2017 PDA Europe The Universe of Pre-filled Syringes and Injection Devices

The Parenteral Drug Association presents:

2017 PDA Europe Conference, Exhibition

The Universe of Pre-filled Syringes & Injection Devices Improving Patient Outcomes with Innovative Drug Delivery

pda.org/EU-UPS2017

7–8 November 2017 Austria Center Vienna | Austria

14th The Universe of Pre-filled Syringes & Injection Devices The Parenteral Drug Association warmly invites you to join the 14th edition of The Universe of Pre-filled Syringes and Injection Devices!

Since its first edition in 2004, the conference has become a fixture in the calendar for the pharmaceutical industry, and a must-attend event for everyone working in the fields related to parenteral drug and device development.

For its 14th year, the European event once again returns to Vienna, one of Europe’s most vibrant cities.

The Austrian capital perfectly integrates tradition and innovation, with an overwhelming cultural offer of the arts and the sciences.

Geographically situated between central and southeastern Europe, with its many neighboring countries, Vienna holds great potential for interaction, exchange of expertise and networking.

By coming to Vienna, you will become part of this cultural melting pot, with unlimited potential for getting involved in the vast professional network of PDA members, speakers and special guests.

Another impressive opportunity to gain access to key decision makers from the pharmaceutical industry as well as government representatives, service providers and manufacturers awaits you!

Join us this fall in Vienna and be part of the world’s largest event on this subject.

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TABLE OF CONTENTS

Introduction

4

Activities at a Glance

4

Pre-Conference Workshops

5

Venue 11 Main Event

12

Letter from the Chairs

13

Conference

14

Conference Agenda

14

Exhibition Floor Plan

20

PDA Education Program

23

Training Course Agendas

23

General Information

33

Registration Form

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ORGANIZER PDA Europe Am Borsigturm 60 13507 Berlin | Germany Tel: +49(0) 30 43 65 50 80 Fax: +49(0) 30 436 55 08 66 info-europe@pda.org VENUE Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna | Austria www.acv.at

RNATION TE

International Pharmaceutical Industry

Supporting the industry through communication

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MEDIA PARTNER

UTICAL IN CE

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ACTIVITIES AT A GLANCE PRE- CONFERENCE WORK SHOPS Monday, 6 November 10:00 – 18:00 Workshop Innovative Drug Delivery Sytems/ Combination Products

8:00 – 18:00 Registration

10:00 – 18:00 Workshop Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals

10:00 – 17:30 Workshop Connected Health & Drug Delivery

CONFERENCE Tuesday, 7 November 7:30 – 18:00

9:00 – 18:00 The Universe of Pre-filled Syringes & Injection Devices

Registration

9:00 – 18:00 Exhibition, Live Demos & Poster Session

19:00 – 22:00 Color the Night Networking Event

Wednesday, 8 November 6:30 – 18:00 Registration

7:00 – 16:00 The Universe of Pre-filled Syringes & Injection Devices

9:00 – 16:00 Exhibition, Live Demos & Poster Session

PDA EUROPE EDUC ATION PROGR A M Thursday, 9 November 8:00 – 18:00 Registration

9:00 – 17:45 Workshop Drug Delivery Systems: Global Technical, Regulatory and Quality Challenges

9:00 – 18:00 Training Course Best Practices and Points to Consider in Aseptic Processing

9:00 – 18:00 Training Course Container Closure Integrity Testing

9:00 – 18:00 Training Course Rapid Microbiological Methods

9:00 – 18:00 Training Course Development and Manufacturing of Pre-filled Syringes

9:00 – 16:30 Training Course Container Closure Integrity Testing

9:00 – 16:30 Training Course Rapid Microbiological Methods

9:00 – 17:00 Training Course Development and Manufacturing of Pre-filled Syringes

Friday, 10 November 8:00 – 12:30 Registration

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8:30 – 17:15 Workshop Drug Delivery Systems: Global Technical, Regulatory and Quality Challenges

9:00 – 16:30 Training Course Best Practices and Points to Consider in Aseptic Processing

9:00 – 17:00 Training Course Container Closure Development

Pre-Conference Workshops 6 November 2017 Innovative Drug Delivery Sytems / Combination Products One-Day Workshop 6 November 2017 Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals One-Day Workshop 6 November 2017 Connected Health & Drug Delivery One-Day Workshop

PRE-CONFERENCE WORKSHOP

Innovative Drug Delivery Systems/ Combination Products From Project Initiation to Life Cycle Management

Workshop Description Increasingly, parenteral products are injected using devices like pen-injectors, auto injectors and wearable pumps. Typically, the primary containers are pre-filled syringes and cartridges. The materials are glass or polymer. Special applications have treated surfaces or coated materials.

Starting with a key note presentation describing the needs of the pharmaceutical and biopharmaceutical industry, this workshop will give an overview of currently used devices. Technical aspects, handling and training, as well as regulations will be highlighted. Device companies will present their products and focus on the most current drug delivery requirements such as: • Mixing technology for liquid/liquid or lyo/liquid formulation combinations

• Large Volume • High Viscosity • High Precision Dosing

Challenges in development impeding a life cycle approach will be one of the themes of the workshop.

Learn from suppliers’ solutions, and hear guest speakers and facilitators share approval and life-cycle management experiences from developing their drug delivery combination products.

Listen to the latest trends in final assembly during drug product manufacturing and what the benefits of target-focused training for users and health care professionals can be. Learn which activities succeeded and hear about the lessons learned. Interact with other participants and speakers during panel discussions and exchange on all issues vital for ensuring success of your product.

Who Should Attend: The target audience for this workshop is from departments like Device Development, Compliance, Operations, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Business Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Control, Clinical Affairs.

Learning Objectives: Upon participation of this workshop you will be able to: • Use combination products to gain market differentiation • Identify to best possible and innovative drug delivery solution for your drug product • Understand the latest trends in drug delivery technology • Implement world class training solutions to prepare for a smooth market entrance • Understand best in class assembly concepts

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WORKSHOP AGENDA 6 Oct 2017

Monday, 6 November 2017

10:00 – 18:00

10:00

Welcome and Introduction

Thomas Schoenknecht, SHL

10:15

Data-driven Discovery: Knowledge Management for Drug Delivery Technologies

Jeffrey Schacherl, Amgen Christian Marc Schmidt, Schema Design

10:45

Life Cycle Approach for Devices

Christian Herget, BD

11:15

Q&A, Discussion

11:30

Device Companies Presentation Overview of Devices by • Becton Dickinson • Bespak

• BIOCORP

• Ypsomed

12:30

Lunch Break

13:30

Device Companies Presentation (cont.)

Overview of Devices by • Dali Medical Devices • Haselmeier • Nypro • Sensile • SHL • Steadymed

• Oval Medical • West

15:30

Coffee Break

16:00

A Novel Autoinjector for High Volume, High Viscosity, and Outstanding Usability

Avi Eliahu, Genentech

16:30

Training for Patients and Medical Professionals

Joe Reynolds, Noble

17:00

Considerations on Lifecycle Management in Scope of Rosemary Gonzalez, SHL the Changing Regulatory Landscape • Recent changes on standards and regulatory expectations/requirements • Considerations on legacy products in light of changing standards

17:30

Q&A on Real Cases, Discussion

18:00

End of Pre-Conference Workshop

Workshop Chair Thomas Schoenknecht, PhD, PDA IG Leader Combination Products, SHL Thomas Schönknecht is currently Executive Director, Business Development at SHL Group, with responsibility for global Business Development, Key Account Management and new Technology Evaluation within SHL’s Medical division. Thomas has over 20 years of experience in pharmaceutical industry in various leading roles in project management, research & development and business development. He received his Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University Goettingen, Germany and a Master’s degree in Chemistry from the University Goettingen. He is currently active as PDA interest group leader combination products in Europe. In addition he had been active as member in various DIN ISO committees regarding primary packaging materials and drug delivery devices.

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PRE-CONFERENCE WORKSHOP

Impact of Pre-filled Syringe Packaging Components on Biopharmaceuticals Workshop Description Parenteral drug delivery using pre-filled syringes and cartridges in combination with devices is of great importance, especially for the application of biopharmaceutical products.

The development of such delivery systems is complex and therefore it is important to consider critical aspects early on in development. This workshop considers the potential influences of primary packaging components on the quality, in particular for biopharmaceuticals. The most relevant aspects are the quality and the chemical and physical interactions of the packaging material with the product. Special considerations are given to the influence of particles, extractables and leachables, silicon oil and handling on the product quality, e.g. aggregation, degradation routes and stability. Experts from academia, the pharmaceutical industry and suppliers of packaging components will share their experiences. There will be plenty of time for discussion, interaction and questions you may have.

Who Should Attend: • Professionals in pharma dealing with development and manufacturing of biopharmaceuticals, container and device development, quality and regulatory functions

Workshop Co-Chairs William Dierick, Terumo William Dierick is Director, Technology Development – Pharmaceutical Solutions of TERUMO, a global research & development company, offering a wide range of innovative products related to drug delivery devices and injection technology, cardiology and cardiovascular systems, transfusion, patient monitoring and clinical systems. With extensive experience in the Medical and Pharma sector for more than 40 years, William has held various positions in Terumo, covering quality assurance, manufacturing, product development & engineering, project management, marketing, corporate planning and business development. He serves as expert of ISO/TC76 and ISO/TC84 and is an active member of Eucomed (MedTech Europe) and volunteer of PDA. John Carpenter, University of Colorado John F. Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado (CU) and Co-Director of the CU Center for Pharmaceutical Biotechnology. His research focuses on mechanisms for protein degradation and stabilization. John has published >270 peer-reviewed papers and holds more than 30 patents. He is an Editor for Journal of Pharmaceutical Sciences and serves on several Editorial Advisory Boards. He has received The Ebert Prize and the American Association of Pharmaceutical Scientists (AAPS) Research Achievement Award in Biotechnology. He is a Fellow of the American Association for Advancement of Science, the AAPS and the National Academy of Inventors.

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WORKSHOP AGENDA 6 Oct 2017

Monday, 6 November 2017 10:00

Welcome

10:00 – 18:00 William Dierick, TERUMO John Carpenter, University of Colorado

KEYNOTE PRESENTATIONS 10:10

Aggregates, Particles and Patient Immunogenicity with Biopharmaceuticals

John Carpenter, University of Colorado

10:40

Factors Affecting Stabilities of Biopharmaceuticals in Pre-filled Syringes

Susumu Uchiyama, Osaka University

11:10

Packaging Components and Biopharmaceuticals: Quality Aspects from Industry Perspective

Hanns-Christian Mahler, Lonza

11:40

Q&A - Discussion

12:00

Lunch Break

Session 1

Aggregation Phenomena

13:00

Protein – Device Compatibility

Flora Felsovalyi, Roche

13:30

Characterization of Particles and Practical Implications

Linda O. Narhi, Amgen

14:00

Ex-Vivo Risk Assessment of Immunogenicity

Mark Fogg, Abzena

14:30

Q&A – Discussion

15:00

Coffee Break

Session 2

Particles

15:30

Particulates in Sterile Drug Products: Testing, Contributions and Mitigation from Packaging Components

Fran DeGrazio, West

16:00

Particles in Packaging Components: Numbers and Chemical Composition

Markus Lankers, Rap.ID

16:30

Q&A - Discussion

Session 3

Extractables & Leachables

16:45

Extractables and Leachables: Impact of Packaging Components on Biopharmaceuticals

Session 4

Functionality

17:15

Needle Clogging of Staked-In-Needle PFS with High Concentration Protein Therapeutics

17:45

Q&A - Discussion

17:55

Closing Remarks by Co-Chairs

18:00

End of Workshop

Piet Christiaens, Toxikon

Monica De Bardi, Roche

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PRE-CONFERENCE WORKSHOP

Connected Health & Drug Delivery

Improved patient convenience and adherence through new technologies

Workshop Description Meanwhile there are a number of technical solutions for smart devices and connected health. In this workshop we will focus on the patient´s perspective. How do patients accept smart devices and what might be challenges for implementation? Patients will talk about their experiences and companies will present approaches they took to get patient´s acceptance.

Who Should Attend: • Professionals from pharmaceutical and supplier companies involved in functions such as clinical, pharmaceutical and container development, as well as business development and marketing, but also people dealing with regulatory issues.

Workshop Chair Markus Bauss, Managing Director, SHL Connect Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology StartUp company ConnectMeSmart GmbH in 2013. In 2015, SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies. From 2004 to 2014, Markus was working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, Markus contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. Markus studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997, prior to moving to the pharmaceutical area.

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WORKSHOP AGENDA 6 Oct 2017

Monday, 6 November 2017

10:00 – 17:30

10:00

Welcome

10:30

The Patient´s Perspective • Expectations of the patient about technology - Two diabetes patients share their experiences

11:00

Products by Patients for Patients Fredrik Debong, mysugr • Experiences, key success factors and lessons learned establishing a mobile health platform for diabetes care

11:30

Injection Devices – How do YOU do it ?

• User centric drug delivery device development • Applying new technology in design process and usability testing to ensure patient convenience

12:00

Discussion

12:30

Lunch Break

Markus Bauss, SHL Connect

Markus Bauss, SHL Connect Jez Clements, Cambridge Design Partnership

TECHNOLOGY & DIGITAL HEALTH PLATFORMS 13:30

The Evolving Perspective of Digital Health

Kal Patel, Flex

14:00

The Internet of Health • Wireless sensors for prevention, cure and care

Chris van Hoof, Imec

14:30

The Move to Connected Devices • Key elements to consider in product design

Andy Schimmoeller, Batelle

15:00

Why Make Your Existing auto-injector “smart” • Comparison of benefits of different accessory form factors and integration into a connected health platform

Brian Lynch, West

15:30

Coffee Break APPLICATIONS IN SPECIFIC THERAPIES

16:00

Connected Health & Rare Diseases • Opportunities through new technology

Dhairya Mehta, Shire

16:30

Creating a Digital Ecosystem to Support Repatha Patients • The potential to support patients before and after the prescription of drug products through complementary digital technologies

Shawn Davis, Amgen

17:00

Panel Discussion

17:30

End of Pre-Conference Workshop

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PRE-CONFERENCE – EXHIBITION FLOOR PLAN

Buffet/Coffee Station Table Top 2 m x 2,5 m (5 m2)

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1

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Workshop Rooms TO EXHIBIT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry.

Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.995 Euro net. For more information please contact expo-europe@pda.org

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Carefully Crafted

Sensitive biopharmaceuticals?

We take the challenge • Drug delivery solutions & technologies for injection and infusion • Expert platforms in pharmaceuticals, polymers, coatings, precision and miniaturization technologies • PLAJEX™ available in staked-needle and integrated luer lock format • Silicone oil-free configuration • Uncompromised Quality and Regulatory Affairs support

www.terumo-ps.com

PS12GB-0616VIN-I(06.16)

• Committed to improved drug delivery and patient comfort

World leader in integrated containment and delivery systems Patient Focus: Sharing our partners’ goals of improving patient health Quality Driven: Delivering high-quality products that meet industry leading specifications Global Reach: More than 50 sales, manufacturing and R&D centers around the world A Trusted Partner: Helping to address the needs of patients and the challenges of our partners for more than 90 years

For more information, contact West today. www.westpharma.com West and the diamond logo is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. © 2017 West Pharmaceutical Services, Inc.

9822 • 0717

VENUE

Austria Center Vienna Level -2 (Brown Level)

G TRACK B

K TRACK C

CONFERENCE AREA

D TRACK A

Speakers Ready Room

Smart Phone Loading Stations Access to Parking

ENTRANCE PDA Registration

WC

Demo Booth 5

Demo Booth 1

EXHIBITION HALL Demo Booth 2

E XHIBIT HALL C AT E R I N G A R E A

EXHIBITION ARE A Demo Booth 3

Demo Booth 4

Demo Booth 6

WC

Demo Booth 7

Demo Booth 8

POSTER SESSION

DETAILED CONFERENCE EXHIBITION FLOOR PLAN ON PAGES 22–23

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MAIN EVENT

Conference 7–8 November 2017 The Universe of Pre-filled Syringes and Injection Devices 7 November 2017 7:30 Registration | Welcome Coffee & Exhibition 8 November 2017 6:30 Registration | Welcome Coffee & Exhibition

proudly provided by

Join our Welcome Party at the Highest Point of Vienna

6 November 2017 19:30 - 22:30 MeliĂĄ Hotel | BAR 57 Donau City Strasse 7 1220 Vienna

Included in full Conference and Exhibition Registration Fee. First come first served. See details on Registration Form.

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LETTER FROM THE CO-CHAIRS Dear Colleagues, During the last decade, PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject. We are looking forward to welcoming you to the 14th edition of this event, to be held 7–8 November 2017 at the Austria Center Vienna.

There is a continued process in the pharmaceutical and biopharmaceutical industry to improve the application of injectables. Starting from primary packaging solutions to devices with increased functionalities, new concepts are being developed to better serve the patient needs. Innovations cover a broad range like new materials, new devices, smart devices, special application systems for challenging formulations. Together with these innovations new manufacturing, handling and testing requirements need to be developed. Furthermore, regulatory demands are constantly changing as well, posing challenges to everyone involved in pharmaceutical science, technology and manufacturing of parenterals.

The Universe of Pre-filled Syringes and Injection Devices brings together industry and regulatory experts annually to share their experiences, new developments, regulatory considerations, trends and best practices.

Do not miss the opportunity to gain access to and network with key decision makers from the pharmaceutical industry as well as suppliers and manufacturers.

The Austria Center in Vienna has proven to be the ideal location for PDA Europe‘s largest event, offering seemingly endless space and possibilities to create a very unique atmosphere, thereby contributing to the event‘s tremendous success in 2015. Austria‘s largest conference centre is located in the heart of the United Nations’ City Department of Vienna, only a few minutes from the center of one of Europe’s most vibrant cities.

Join us there, the perfect place to explore and get immersed in the pre-filled syringes universe!

Sincerely, the Co-Chairs

SCIENTIFIC PROGR AM PL ANNING COMMIT TEE Mathias Romacker, Conference Co-Chair, Pfizer Hanns-Christian Mahler, Conference Co-Chair, Lonza Markus Bauss, SHL Group Michael Betz, Roche/Genentech Christina Braden-Moore, BD Medical William Dierick, Terumo Olivia Henderson, Amgen Laurent Jeanmart, GlaxoSmithKline Lei Li, Eli Lilly & Co. Manfred Maeder, Novartis Brigitte Reutter-Härle, Vetter Mike Schäfers, West Michael Selzer, Regeneron Ian Thompson, Ypsomed Georg Roessling, PDA Europe Sylvia Becker, PDA Europe

Mathias Romacker, PhD Conference Co-Chair, Pfizer

Hanns-Christian Mahler, PhD Conference Co-Chair, Lonza

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CONFERENCE AGENDA

Tuesday, 7 November 9:00

Welcome: Opening Remarks & Introduction

Georg Roessling, PDA Europe Mathias Romacker, Pfizer Hanns-Christian Mahler, LONZA, Conference Co-Chairs

Opening Plenary: Current Trends & Future Outlook

Moderator: Mathias Romacker, Pfizer

Our conference on Pre-filled Syringes and Injection Devices aims to highlight future technology and regulatory trends of all aspects related to application device technology. At the center of our Universe of Pre-filled Syringes and Injection Devices, however, is the patient. Working in the pharmaceutical industry, regulatory agencies or industries supplying and enabling us to develop and to market these cutting-edge pharmaceutical products and delivery systems, we all are committed to serving patients both in developing countries as well as industrial nations. Safe and efficient application of complex biologics, whether to merely reduce fear of needle and pain, or to increase patient´s adherence, improve compliance, reduce waste, etc., are our core goals. Smart devices and connected technologies will open up new horizons in our healthcare universe, providing patients with easier, safer and more effective solutions of drug administration. This and more key drivers for advancing the development of pre-filled syringes and injection devices will be presented over the course of these two days!

Hall D

KEYNOTE PRESENTATIONS

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9:10

Drug Delivery Needs in Developing Countries

WHO invited

9:40

The Evolving Perspective of the Pharma Company on Devices and Connectivity

Simon Wilson, Pfizer

10:10

Coffee Break, Poster Session & Exhibition Featuring live Demo Booths

11:00

Finding the Right Solution for the Patient: Using Novel Devices to Deliver Molecules from an Increasingly Complex Pipeline

Sheldon Moberg, Amgen

11:30

Device Development for Biosimilars

Florian Turk, Sandoz Biopharmaceuticals

12:00

Smart Devices - How to Unlock their Potential in the Real World

Tobias Handschuh, Ernst & Young

12:30

Discussion, Q&A

12:45

Lunch Break, Poster Session & Exhibition Featuring live Demo Booths

13:45

Transition to Parallel Tracks

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CONFERENCE AGENDA

PARALLEL TRACKS Hall D

Hall G

Hall K

TRACK A

TRACK B

TRACK C

Patient-Device Interface

Manufacturing and Technology

Marketing and Business Development

Session 1 New Applications & Challenges

Development

Marketing & Lifecycle Management

Moderator: Christina Braden-Moore, BD

Hanns-Christian Mahler, LONZA

Manfred Maeder, Novartis

14:00

Foundational Research on Subcutaneous Injection Physiology to Improve Biologics Delivery Systems and Patient Experience

Formulation & Administration of Ocular Dosage Forms – Requirements and Challenges

Syringe Auto Injector Portfolio Commercialization Development – Challenges and Opportunities

Michael W Harrison, Eli Lilly Graham Jones, Tufts Medical School

Dhanajay Jere, Lonza AG

Chris Mitchener, Eli Lilly

Advances in Intradermal Drug Delivery - From Vaccines to Immunotherapy and Beyond

High Volume Injectors: Case Study of an Assessment & Compatibility Test with a Biologic Drug Product

A Case Study: Development of a Pre-Filled, Wearable, Single-Use, Infusion Pump

Gal Admati, NanoPass Technologies

Pierre Goldbach, Roche

Peter Noymer, SteadyMed

Lucentis Pre-filled Syringe – Challenges and Opportunities

Control Strategy for Combination Products

Commercial Success of a 3rd Generation Digital-Auto Injector: Commercialization, Sustain­ability and Environmental Impact

Marie Picci, Novartis

Christof Golla, Novartis

Steven Lynum, Panasonic-Healthcare Takashi Hanada, JCR Pharmaceuticals

15:15

Q&A, Discussion

Q&A, Discussion

Q&A, Discussion

15:30

Coffee Break, Poster Session & Exhibition Featuring live Demo Booths

16:15

Transition to Parallel Tracks

14:25

14:50

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CONFERENCE AGENDA

PARALLEL TRACKS Hall D

Hall G

Hall K

TRACK A

TRACK B

TRACK C

Patient-Device Interface

Manufacturing and Technology

Marketing and Business Development

Session 2 Smart Devices

Manufacturing

Investment

Moderator: Markus Bauss, SHL Connect

Mike Selzer, Regeneron

Mathias Romacker, Pfizer

16:30

Highlights of Smart Devices Pre-Conference Workshop

Challenges in the Filling of Drug Product Formulations

Pharma Perspective on Device and Development Models and Investment

Markus Bauss, SHL Connect

Simon Hanslip, GSK Vaccines

Nic Bowman, Pfizer

16:55

17:20

17:45

18:10

The Changing Diabetes Building a Flexible Robotic Landscape – Linking Diagnostics Small Scale Filling Line with Injection

Technical Integration of Device Systems and Associated Business Process to Accelerate Innovation

Aileen Kinsella, WEST

Martin Bultmann, AbbVie

Justin Wright, Eli Lilly Marty Coyne, Matchstick

Smart Drug Delivery Devices for Home Use

Clinical Manufacturing Flexibility

Funding and Building a Business that Provides Pharma Innovations in Drug Delivery

Martin Koch, Roche

Susanne Resatz, Vetter

John Merhige, Credence MedSystems

Improving Patient Outcomes Pre-fillable Syringe Selection with Mixed Reality and Artificial Criteria for Vaccine: Technical Intelligence Technologies Comparison of Several Syringe Types

Case for Re-Usable Autoinjector

Kai Worrell, Worrell

Laurent Jeanmart, GSK Nicolas Eon, SCHOTT

BjĂśrn Knud Andersen, Medicom

Q&A, Discussion

Q&A, Discussion

Q&A, Discussion

19:00 Networking Event Color the Night

Networking Event 7 NOVEMBER 2017

19:00 h AUSTRIA CENTER

I n c l u d e d i n f u ll C o n f e r e n c e a n d E x h i b i t i o n R e g i s t r a t i o n F e e . F i r s t c o m e f i r s t s e r v e d . S e e d e t a i l s o n R e g i s t r a t i o n F o r m .

CONFERENCE AGENDA

Wednesday, 8 November Morning Session: PDA Interest Group Meeting Packaging Science

Moderators: Bettine Boltres, WEST Derek Duncan, LIGHTHOUSE

8:45

Welcome Coffee, Poster Session & Exhibition

Hall D

7:30

PARALLEL TRACKS Hall D

Hall G

Hall K

TRACK A

TRACK B

TRACK C

Patient-Device Interface

Manufacturing and Technology

Marketing and Business Development

Session 3 Clinical Needs

Processing & Assembly

Market Trends & Reimbursement

Moderator: Mike Schäfers, WEST

Michael Betz, Roche

Brigitte Reutter-Haerle, Vetter

9:00

Future of Parental Drug Delivery - Wearable Injector: Latest Trends Development and Innovation

Injectable Drug Delivery Market Trends & Rethinking Best Practice in Developments Manufacturing based on Smart Objects & Intelligent Machinery

Sudeshna Dutta Ray, Amgen

Markus Bauss, SHL Connect

Brigitte Reutter-Haerle, Vetter

De-risking Clinical Trial Outcomes through Preclinical In-Vivo Models for Large Volume Subcutaneous Injections

Finished Pre-filled Syringes Integrity Testing: Method Development, Validation and 100% in-line High Speed Solution

Influence of Outcomes-based Reimbursement on Drug Delivery Technologies

Natasha Bolick, BD Medical

Giovanni Golinelli, Bonfiglioli Engineering

Scott Gibson, Amgen

Assessing the Pain in Different Injection Sites

Device Assembly: Best Practices and Lessons Learned for Successful Device Assembly Execution and Industrialization

Payer Perspectives on the Drug Delivery Device Value Proposition: Opportunities, Challenges and Implications

Chris Muenzer, Roche

Jovo Dragicevic, AbbVie

Max Cambras, LEK

9:30

10:00

10:30

Coffee Break, Poster Session & Exhibition Featuring live Demo Booths

11:00

Transition to Parallel Tracks

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CONFERENCE AGENDA

PARALLEL TRACKS Hall D

Hall G

Hall K

TRACK A

TRACK B

TRACK C

Patient-Device Interface

Manufacturing and Technology

Marketing and Business Development

Session 4 Human Factors

Inspection

Business Strategies

Moderator: Ian Thompson, Ypsomed

Hanns-Christian Mahler, LONZA

William Dierick, Terumo

11:15

New Methods of Measuring Device Usability: Bridging The Gap Between Human Factors and Clinical Studies

High Speed Automated Inspection with Container Closure Integrity Testing for Pre-filled Syringes

The Crossroads of Pharma Lifecycle Management - How Best Practices Determine Winners and Pitfalls

Vladimir Matejak, Pfizer

Wes Maharas, Eli Lilly Rene de Munk, Seidenader

Christian Herget, BD Medical

An Actual-Use Human Factors Study for an Autoinjector

A Case Study for Mitigation of Visual Particulate in Glass Syringe Manufacturing

The Furosemide Story: Transforming a Heart Failure Drug from IV to SC On-body Injection

Florian Wildenhahn, Roche

Luis Baez, Amgen Anthony Vico, OMPI

Gerhard Mayer, Sensile-Medical Troy Ignelzi, SCPharmaceuticals

11:35

11:55

Application of Eye-Tracking for A New Option: Silicone-Free the Development of New SelfPlunger and Bare Glass Barrel Injection Systems: Insights from the SmartPilot Case Study

Autoinjector Selection Process for a Pharmaceutical Drug Product

Andreas Schneider, Ypsomed

Russell Hornung, WL Gore

Jรถrg Sielemann, Roche

12:15

Q&A, Discussion

Q&A, Discussion

Q&A, Discussion

12:30

Launch Break, Poster Session & Exhibition Featuring live Demo Booths

Hall D

Closing Plenary

22

Moderator: Georg Roessling, PDA Europe

14:00

Manufacturing Highlights: Syringe Filling, Device Manufacturing

Jerry Cacia, Roche

14:30

The Future of Parenteral Drug Delivery in a Connected Health Ecosystem

Andrew Ratz, Eli Lilly

15:00

Closing Panel Discussion

Moderators: Manfred Maeder, Novartis Laurent Jeanmart, GSK

16:00

Farewell & End of the Conference

Georg Roessling, PDA Europe

pda.org/EU-UPS2017

®

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OEM/pda/ad/ob/0917/7

EXHIBITION FLOOR PLAN Overview

G TRACK B

Legend

K

Regular Booth

TRACK C

CONFERENCE AREA

Sponsor Package 12m2 Sponsor Package 6m2 D

Demonstration Booth

TRACK A

Innovation Gallery Lounge Area

Speakers Ready Room

Catering Area

Smart Phone Loading Stations Access to Parking

X

ENTRANCE PDA Registration

Demo Booth 1

Y

E XHIBIT HALL C AT E R I N G A R E A

Emergency Exit

Demo Booth 5

EXHIBITION HALL EXHIBITION AREA Demo Booth 2

Charging Station

WC

Demo Booth 6

Demo Booth 3

Demo Booth 7

Demo Booth 4

Demo Booth 8

WC

Hydrant

POSTER SESSION

WARDROBE

MAIN ENTRANCE H

CATERING

H H

B AR

Schlauchkasten freihalten

PDA REGISTRATION

CO M M U N I CAT I O N S CO RN E R

Y05

Y06

Y07

Y08

Y09

Y10

G1 H

G2

G3

Vetter

Portal Instruments

G4

G5

INNOVATION GALLERY

NOBLE WORKING LOUNGE

G6

G7

G8

G9

G10 Biocorp

Zenius

Y41

Primeequal

Y42

Y33

Y34

Connecticut Spring & Stamping

IMA Medtech

Plas-Tech Getinge

ZEON

Y47

Y62 POST E R SE SSI ON

4 M ACHINERY BOOTH 12m 2 total 24m 2

Ated

Afton

Y58

Y59

Y60

Y61

Y69

Y70

Y71

Y72

POSTER SESSION

H

H

Halle:

ACV

EXHIBITION AREA Y 24

pda.org/EU-UPS2017

Auftragsnr.:

Kunde:

Standnr.:

X3

Alle Angebotsunterlagen bleiben Eigentum der Expoxx

EXHIBITION AREA X OWEN MUMFORD WORKING LOUNGE

Conference Area Fareva

Zahoransky

Rommelag

Heuft

SCScoatings

Bausch

Lighthouse Raumetic

Bosch

Plas tech

Credence

Nipro Europe

Bausch & Ströbel

Steris

Copernicus

X20

Exhibition Area X Flextronics

Cook Pharmica

Rovi

Zwick

IGS

Team Consulting

PTI

WhiteHouse Labs

Steriline

APEX

Baumann Federn

PC

Noble

TeamTechnik

Panasonic

H

Ypsomed

E3D ACA LTD Nemera

Bühler Motor

VanRx

One World

Mikron

Haselmeier

Merck

Aptar

WC Yukon Sumitomo

X60

X61

OMPI OMPI

Terumo

Sartorius

Fargo

Cambridge Consultants

Insight

Sio2

Dali

CC Biotech.

Phillips Medisize West

Sensile

OPTIMA

X77

MGC

SHL

Sonceboz

Multivac

Vetter

VETTER Lounge WORKING Area LOUNGE

BESPAK Lounge Area WORKING LOUNGE

CATERING

WC Toxikon

X105

Lonza rap.ID

SCHOTT

Reserved for Bespak 12m2 Sponsor Package

BD

Oval Technl.

Kahle Datwyler

Dara

BD BioCorp

Brevetti CEA

Insulet Triboglide

3P

Tasi Test

X103

Camb.

Design

Fresenius Kabi

groninger Gerresheimer

Brevetti Lyophilization Angela Smithers & Rapra

DuoJect

2 X113 X114 MACHINERY

Owen Mumford

BOOTH 12m 2 X127 X1282 total 24m

Gateway Analytical Transcoject

Preh IMA

Schreiner Medipharm

Gore

X119

X96

Eveon Enable injections

Reserved for 6m2 Sponsor Package

Fuhr

Batelle

TPP

X124

Weidmann Medical

X126

Rovi

X128

Topas

X130 Coffee

CATERING

Catering

ROCHE LoungeLOUNGE

DATWYLER WORKING LOUNGE

H

Zng-Nr

Plan-Nr

001

002

Messe:

Projektleiter:

PDA Europe M:

Blatt:

1: 80

A0

Benennung:

-------

TO EXHIBIT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry.

Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 2.995 Euro net (excl. booth charges). For more information please contact expo-europe@pda.org M.Ebner

Datum:

04.10.2016

Bearbeiter:

PH

EXPOXX MESSEBAU GmbH Messeplatz 1, Postfach 277, A-1021 Wien T: +43 (0) 1 / 727 20-6101 F: +43 (0) 1 / 720 19-6109 info@expoxx.at - UID-Nr.: ATU 37633003

x Messebau GmbH und können jederzeit zurückverlangt werden.

Sie dürfen nicht vervielfältigt oder Dritten zugänglich gemacht werden.

pda.org/EU-UPS2017

25

People are different and so are diseases.

That’s why we are committed to discovering and developing personalised medicines and targeted diagnostic tests to help people live better, longer lives.

BE PART OF THE PDA

INNOVATION GALLERY

Each glass showcase is available for 1995 € and includes the following benefits: • 1 Free Exhibition Ticket for Booth Personnel (450 € for additional expo-only tickets) • Prominent location with showcase, bar stool (total space of 2 x 2 meters) • Online Exhibitor Listing on PDA Europe Website • Listing in the event app including Company Description and Logo • Personal Support On-Site • Admission to Networking Event (7 November) • All Lunches & Coffee Breaks served in the Exhibition Area Apply by submitting a brief abstract description of 200 words including picures and movies (if available) to demonstrate why your product is eligible to receive focussed attention!

Deadline :

31 August 2017

Be at the center of the Exhibition Area Y!

Please send your proposal directly to gomez@pda.org

Training & Education Program

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pda.org/EU-UPS2017

PDA

Education offers courses that are developed and taught by experts. They are uniquely targeted to professionals involved in the development and manufacturing of quality pharmaceutical and biopharmaceutical products.

Facts that Make a Difference Up-to date training courses and workshops taught by internationally renowned instructors Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation Customized in-house training courses and workshops available

9 November 2017 Container Closure Development One-Day Training Course 9–10 November 2017 Container Closure Integrity Testing: Regulations, Test Methods, Application Two-Day Training Course 9–10 November 2017 Rapid Microbiological Methods Two-Day Training Course 9–10 November 2017 Best Practices and Points to Consider in Aseptic Processing Two-Day Training Course 9–10 November 2017 Development and Manufacturing of Pre-filled Syringes - A Hands-on Training Course Two-Day Training Course 9–10 November 2017 Drug Delivery Sytems: Global Technical, Regulatory and Quality Challenges Two-Day Workshop pda.org/EU-UPS2017

29

ONE-DAY TRAINING COURSE

Container Closure Development Overview The course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered, like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.

For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.

Who Should Attend: •

Scientists in Drug Product Development

•

Scientists/ Engineers in Packaging Development

•

Regulatory Affairs Experts

Learning Objectives: •

Set-up of a target product profile of a container closure system

•

Select appropriate container closure materials, components, and systems

•

Apply the appropriate regulations and standards to container closure systems for parenteral formulations

•

Prepare a development plan of a container closure systems from the early development until market phase

•

Specify container closure system regarding technical aspects and regulatory requirements

•

Understand compendial requirements and quality as well as technical standards regarding container closure components and systems

Jörg Zürcher, Senior Scientist, Bayer Jörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.

30

pda.org/eu/CCD2017

TRAINING COURSE AGENDA 6 Oct 2017

Thursday, 9 November 2017 9:00

Welcome & Introduction

9:10

Setting up a Target Profile • Influence of formulation (small molecule, biological) • Use of product (patient, nurse, physician....)

• Regulatory requirement

9:30

Material Selection • Ph.Eur. / USP / JP • Plastic vs. glass • Coating of material • Stopper material

10:30

Coffee Break

11:00

Selection of Packaging Solution

11:30

Assessment of Packaging Solutions – Development Data • Testing of injection vials/bottles and their respective components • Testing of pre-filled syringes (PFS) and their respective components • Extractables & Leachables (E&L) testing • Mechanical and functional testing

12:30

Lunch Break

13:30

Manufacturing of Packaging Solutions • Test runs • Process validation (risk assessment, critical parameters) • Container closure integrity (physical vs. microbiological testing – USP 1207) • Shipping test for PFS

14:00

Setting of Specifications • Technical drawings • Technical / quality specification • Testing standard, defect evaluation list • Examples

15:00

Coffee Break

15:30

Preparing the Submission • Relevant eCTD sections (drug substance and drug product) • Regulatory drawings • DMF for US

16:00

Routine and Release Testing • Certificates • Routine E&L testing • Reduced testing

16:15

Change Management • EU requirements

16:30

Wrap-up, Discussion, Q & A

17:00

End of Training Course

9:00 - 17:00

pda.org/eu/CCD2017

31

TWO-DAY TRAINING COURSE

Container Closure Integrity Testing Overview This workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The Workshop will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this Workshop, participants gain critical problem solving skills through: •

interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers

•

hands-on testing training on the newest innovations and state-of-the-art instruments

•

real-world case studies.

Who Should Attend • Parenteral drug packaging engineers and formulation scientists

Presentation of Technology, Instruments Demo and Hands-on Training kindly supported by different manufacturers of testing instruments

• Laboratory scientific staff and managers • Parenteral manufacturing staff • Sterility Quality Assurance • Regulatory affair scientists • Pharmaceutical packaging component manufacturing staff

Learning Objectives This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laserbased gas headspace analysis, mass extraction leak test.

• Understanding up-to-date regulatory and pharmacopeia requirements on CCI.

• Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.

• Defining CCI requirements for various container and drug product types using a risk-based approach.

• Defining CCI testing method development and validation approach and best practices.

• Explaining working principles of various CCI testing techniques and their practical applications, with focus on

• Avoiding common issues and pitfalls in CCI testing applications

Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain distribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

32

pda.org/eu/CCI2017

TRAINING COURSE AGENDA

Thursday, 9 November 2017

9:00 – 18:00

Friday, 10 November

9:00 – 16:30

9:00

Welcome

9:00

Day-1 Review

9:30

CCI Introduction, Regulatory Requirements, and Industry Trends • Introduction to container closure integrity • Regulatory requirements

9:30

Development of CCI Testing Strategy • Testing requirement definition • Testing strategy development • Examples and case study exercise

10:30

Coffee Break

10:00

11:00

CCI Introduction, Regulatory Requirements, and Industry Trends (Continued) • Compendia updates: USP 1207 revision updates, EP • PDA TR 27 revision updates

Approaches to CCI Testing Method Selection • Method selection considerations • Testing method selection guidance • Examples and case study exercise

11:30

Introduction to CCI Test Methodologies • Classification: deterministic vs probabilistic; microbiological vs physicochemical methods; by limit of detection • Key method performance characteristics • Laboratory bench-top testing v.s. online 100% inspection • CCI v.s. Seal Integrity Testing

10:30

Coffee Break

11:00

Instrument Demo and Hands-on Training: 1. HVLD station 2. Vacuum decay 3. Mass Extraction

12:30

Lunch Break

13:30

Instrument Demo and Hands-on Training: 4. Headspace 5. Helium leak detection 6. Seal quality tests

14:30

Coffee Break

15:00

Development and Validation of Integrity Test Methods • Method development best practices • Method validation strategy • Pitfalls and solutions

16:00

Course Summary

16:30

End of Workshop

12:00

Lunch Break

13:00

Advanced CCI Testing Technologies and Seal Quality Testing Technologies 1. Vacuum decay 2. Mass Extraction 3. Headspace analysis 4. Headspace moisture

15:00

Coffee Break

15:30

Advanced CCI Testing Technologies and Seal Quality Testing Technologies 5. HVLD 6. Helium lead detection 7. Seal quality test

17:30

Day-1 Summary; Case Study Assignment

18:00

End of Day 1 Jennifer Roark, B.S., Manager Chemistry & Container Testing, Eurofins Medical Device Testing

As Manager of Chemistry and Container Testing, Jennifer Roark oversees testing to support the container and package testing needs of both pharmaceutical and medical device clients. Her group specializes in various CCI testing technologies such as vacuum decay, high-voltage leak detection, FMS oxygen headspace, pressure decay, and dye immersion. She also supervises the physiochemical testing associated with the USP, EP, and JP General Chapters on plastics, elastomeric closures, glass, and container performance testing. Jennifer has more than 22 years of analytical testing experience and serves as one of Eurofins’ leading subject matter experts for Extractables and Leachables Testing. She currently serves on ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, Subcommittee E55.04 General Biopharmaceutical Standards, leading the efforts to draft standard WK43945. Jennifer Roark has been involved with small molecule methods development and validation for over 12 years, and has co-published a series of articles on method validation. pda.org/eu/CCI2017

33

TWO-DAY TRAINING COURSE

Rapid Microbiological Methods Overview This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans. Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

Who Should Attend: • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QP • Level of Expertise: Senior Management, Scientists/Technicians • Job Function: Supervisor, Researcher, Analyst, Operative Personnel

Learning Objectives: • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods • Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures; explore case studies and actual workflows for dozens of commercially-available technologies • Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels • Develop business plans and return on investment justifications, follow an actual case study in significant cost savings and cost avoidances by implementing a RMM for environmental monitoring • Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, the new USP 1223 chapter and the proposed Ph. Eur. Chapter 5.1.6 Michael J. Miller, PhD, President, Microbiology Consultants, President Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies. Michael currently serves on a number of PDA’s program and publication committees and advisory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.

34

pda.org/eu/RMM2017

TRAINING COURSE AGENDA 6 Oct 2017

Thursday, 9 November 2017 9:00

Welcome

9:15

Introduction to RMMs, Applications, Implementation Strategies, Opportunities

9:00 – 18:00

Growth-based RMMs; Scientific Principles, Applications and Case Studies 10:30

Coffee Break

11:00

Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO

12:30

Lunch Break

13:30

Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies Viability-based RMMs; Scientific Principles, Applications and Case Studies

15:30

Coffee Break

16:00

Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies

18:00

End of Day 1

Friday, 10 November 2017

9:00 – 16:30

9:00

Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies

10:30

Coffee Break

11:00

MEM-based RMMs; The Future of Alternative Technologies Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics

12:30

Lunch Break

13:30

Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, the New USP 1223 and the Proposed Ph. Eur. 5.1.6 A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations

15:00

Coffee Break

15:30

References, On-line Resources and Final Remarks

16:30

End of Training Course

pda.org/eu/RMM2017

35

TWO-DAY TRAINING COURSE

Best Practices and Points to Consider in Aseptic Processing Overview Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all.

Who Should Attend: Personnel involved in Aseptic Processing from sterile production departments such as: • Production Management and Shop Floor Supervisors • QA and QC Microbiologists • Qualified Persons • Personnel from technical department A basic understanding of Aseptic Processing is a prerequisite.

Learning Objectives: • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.

• Understand key requirements and challenges in parenteral production • Understand the importance of a good quality culture within a company • Apply the executed and presented case studies and team exercises in her/his daily job • Get answers and interpretations about - potentially - unresolved questions and problems • Gain confidence for audits

Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH For the past five years, the microbiologist Guenther Gapp has been working as an independent consultant with different clients and contractors worldwide. In many projects he has been engaged as “Aseptic Processing Expert” for projects worldwide in remediation of companies cited with Warning Letters, audits and other assignments. In his previous career, Guenther spent 20 years in the pharmaceutical industry as Head of QA/ QC Microbiology and as Sterility Assurance Expert and Troubleshooter. During this period, he gained in-depth experience in aseptic processing key elements. He has been a subject matter expert in more than 20 FDA audits. Guenther also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of sterile products, and this method is now in use worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. Since 2017 he is also member of PDA Task Force groups regarding Aseptic Processing Industry Survey and the EU Annex 1 revision, and member of the PDA Science Advisory Board. A brand new initiative is to assess and improve the current hygiene conditions and aseptic working practices in local Austrian hospitals, aiming to reduce the threatening “nosocomial infection rates” of patients.

36

pda.org//bestpractices-aseptic

TRAINING COURSE AGENDA 6 Oct 2017

Thursday, 9 November 2017

9:00 – 18:00

9:00

Welcome

9:30

Introductional Test about Selected Hot Topics in Aseptic Processing - Discussion of Answers

10:30

Coffee Break

11:00

Importance of a Good Quality Culture in Aseptic Processing – What May Go Wrong

11:30

Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

12:30

Lunch Break

13:30

Aspects of Clean Room Concepts and Good Aseptic Working Practices - Conventional Filling Lines, RABS Systems and Isolators

14:30

Team Exercise: Preparing a New Concept for Start-Up of an Aseptic Filling Line

15:30

Coffee Break

16:00

Hot Topics in Pharmaceutical Water Systems and Best Control Practices

16:30

Effective Oversight at the shop-floor, Good Training Methods

18:00

End of Day 1

Friday, 10 November 2017

9:00 – 16:30

09:00

Guidance How to Execute in Media Fills and Process Simulations (Definition of Worst Case Criteria), Sterile Active Product Ingredients, PDA TR 22

10:00

EU Annex 1: What Are the Changes

10:30

Coffee Break

11:00

Important Aspects in Environmental Monitoring and Team Exercise, PDA TR 30

12:30

Lunch Break

13:30

Applications of Risk Assessments for Microbial Contamination Control and for Supporting Decisions in Case of EM-Deviations (HAZOP and FMEA)

14:30

Selection of Case Studies About Microbiological Deviations, Related Root Causes and CAPAs in Aseptic Processing

15:30

Coffee Break

16:00

Summary & Discussion of Open Questions

16:30

End of Course

pda.org//bestpractices-aseptic

37

TWO-DAY TRAINING COURSE

Development and Manufacturing of Pre-filled Syringes A Hands-on Training Course Overview This two-day interactive course will provide an overview of relevant practical aspects and trends of developing and processing of bulk and pre-sterilized primary packaging systems, especially pre-filled syringes. It will also address relevant regulatory aspects and topics such as container handling in the filling process, glass defects, particulates and visual inspection and the relevant test methods. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology. There are discussion and Q&A sessions with real case examples.

Who Should Attend This course offers valuable insights and updates for anyone involved in development, production, quality, auditing, project management and purchasing

Learning Objectives Upon end of this course you know about and have an overview of: • Processes involved in primary packaging manufacturing, filling and processing • Test methods for development, IPCs and quality testing • Relevant machines and test equipments Learn about the complexity and interdependencies of the development and manufacturing of Pre-filled Syringes and get an understanding what to consider for a successful project.

Faculty Moderator: Egmont Semmler, PhD, Director Research & Development, Groninger Speaker: Erik Berndt, Industry Manager Medical/Pharmaceutical, Zwick Alessandro Morandotti, Product Manager Syringes, Nuova Ompi Christa Jansen-Otten, Director Marketing PFS Europa, West Horst Koller, CEO, HK-Packaging Consulting Oliver Valet, PhD, Managing Director, rap.ID Bernd Zeiss, Manager Technical Support Medical Systems, Gerresheimer

38

pda.org/eu/dev_syringe

TRAINING COURSE AGENDA 6 Oct 2017

Thursday, 9 November 2017

9:00 – 18:00

9:00

Welcome

Egmont Semmler, Groninger

9:05

Advantages of Pre-filled Syringes and Market Trends in Primary Packaging • Properties and advantages of Pre-filled Syringes • Market overview of the injectables markets • Trends in parenteral applications

Christa Jansen-Otten, West

9:30

Development and Regulatory Aspects of Primary Packaging • The relevant guidelines • Vial- syringe life cycle management considerations

Horst Koller, HK Packaging

10:00

The Complete Manufacturing Process of Pre-filled Syringes • Washing, endotoxin testing • Siliconization, types of silicon oils and application • Sterilization and silicon oil fixing • Ready to fill glass syringe handling

Egmont Semmler, Groninger

10:30

Coffee Break

11:00

The Complete Manufacturing Process of Pre-filled Syringes (cont.)

• Filling methods, pumps • Stoppering methods • Selection criteria for filling and stoppering

11:30

Q&A on Manufacturing

12:00

Lunch Break

13:00

Testing of Pre-filled Syringes (Siliconization, Visual Inspection) • Silicon oil layer measurements • Visual inspection, criteria

Oliver Valet, rap.ID

13:30

Testing of Pre-filled Syringes (ISO 11040-4 and more) • The ISO standards • Needle penetration test • Flange and Luer cone • Pull-off forces on tip caps breakage resistance • Test equipments • Glide force tests • Luer-lock tests

Erik Berndt, Zwick

14:00

Q&A on Testing

14:30

Coffee Break

15:00

Interactive Hands-on Session • Manufacturing machines: Siliconization, filling procedures, stoppering methods • Testing equipment: Silicon layer, particle identification, glide force and methods acc. to ISO 11040-4 • Container closure integrity testing

17:00

Q&A, Discussion and Real Case Examples • What can go wrong and how to avoid or fix it

18:00

End of Day 1

Egmont Semmler, Groninger

pda.org/eu/dev_syringe

39

TRAINING COURSE AGENDA

Friday, 10 November 2017

40

9:00 – 17:00

9:00

Glass Syringes • Manufacturing of glass • Glass forming • Physical and chemical properties • Bulk and Ready to fill concepts • Quality aspects

Alessandro Morandotti, Nuova Ompi

9:45

Polymer Syringes • Materials • Physical and chemical properties • Processing and quality

Bernd Zeiss, Gerresheimer

10:15

Q&A

10:30

Coffee Break

10:30

Elastomeric Closures for Pre-filled Syringes and Cartridges • Manufacturing of elastomers • Physical and chemical properties • Processing: washing / siliconization • Quality aspects / coated and uncoated /bulk and ready to use

12:00

Q&A

12:30

Lunch Break

13:30

Assembly of Syringes into Devices • ISO Standards 11608 • Tests of the primary containers • Tests on the assembled primary container-device • Equipment and test procedures

14:15

Q&A

14:30

Coffee Break – Parallel to next Agenda Topic

14:30

Interactive Hands-on Session, small groups: • Polymer and glass syringes • Elastomer types and selection criteria • Devices • Test Methods

16:00

Q & A, Discussion with Real Life Examples

17:00

End of Course

pda.org/eu/dev_syringe

Christa Jansen-Otten, West

Erik Berndt, Zwick

FOR BETTER TREATMENT OF CHRONIC DISEASES. Across the healthcare continuum, BD is the industry leader in parenteral delivery devices that help health systems treat chronic diseases. We not only continually advance clinically proven, prefillable drug delivery systems, we do so with a vision to help healthcare providers gain better understanding of how patients self-inject their chronic disease therapies outside the healthcare setting. This is why we partner with leading pharmaceutical and biotech companies worldwide to develop digitally-connected self-injection devices—including wearable injectors and autoinjectors— to capture valuable data that can be shared with caregivers. Discover how BD brings new ideas and solutions to customers, and new ways to help patients be healthy and safe. Discover the new BD.

BD Libertas™ wearable injector

BD Libertas™ wearable injector with Smart option

Learn more at bd.com/Discover-BD1 BD Libertas™ wearable injector, BD Libertas™ wearable injector with Smart option and BD Intevia™ autoinjector are products in development; some statements made are subject to a variety of risks and uncertainty. © 2017 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BDPS24234

BD Intevia™ autoinjector

TWO-DAY WORKSHOP

Drug Delivery Systems: Global Technical, Regulatory and Quality Challenges Overview The FDA started to address Drug Delivery Systems as combination products almost 20 years ago and have more recently instituted a growing number of unique ways to regulate the development, registration and control of these products. To make issues more complicated, there are an increasing number of regions that are also starting to treat these products differently. One of these examples is the upcoming Medical Device Regulation (MDR) to be considered also for Drug Device Combinations in Europe. Independent of the regulations, the number, scope and complexity of these products is expanding exponentially. This workshop will provide attendees with insight into the challenges, and potential solutions to dealing with the requirements and regulations related to the development, registration and control of Drug Delivery Systems. The workshop will include speakers from regulators and industry and allow interactive audience participation with panels of experts on each issue to provide a forum for information and discussion on navigating the challenges presented by these products.

Who Should Attend: This course will be geared towards individuals who are responsible for, have input into, oversight for or actively participate on, drug delivery product development teams. This includes the following practitioners, managers and directors in Medical Device, Pharmaceutical or consulting companies:

Workshop Leader Lee Leichter, P/L Biomedical Manfred Maeder, Novartis

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• • • • • • • •

Project Management Marketing Regulatory Affairs Quality Assurance Clinical Affairs Product Safety Human Factors Engineering Device Development Engineering

• • • •

Quality Engineering Formulation Testing laboratories Design Verification Department

WORKSHOP AGENDA 6 Oct 2017

Thursday, 9 November 2017 9:00

Welcome and Introduction

9:00 – 17:45 Manfred Maeder, Novartis Lee Leichter, P/L Biomedical

Current Challenges and Changes Due to New Regulatory Expectations 9:10

Recent and Upcoming Changes and Challenges in the EU

Manfred Maeder, Novartis

9:50

Recent and Upcoming Changes and Challenges in the USA

Lee Leichter, P/L Biomedical

10:30

Coffee Break Regulatory Considerations – How to Submit a Drug Device Combination Worldwide?

11:00

Global perspective on Drug Delivery Submissions - Regulatory

Chin-Wei Soo, Genentech

11:45

Global perspective on Drug Delivery - Quality Requirements - Separate products/Combined Products

Speaker invited

12:30

Lunch Break

13:30

Regulatory Considerations for Drug Device Combinations

Nick Lee, HPRA - Irish Agency

14:15

Notified body position – How will this be implemented?

Bassil Akra, TUEV Sued

15:00

Panel Discussion

15:15

Coffee Break When There are Two Separate Products, How Do the Companies Coordinate?

Labeling/Promotion/Distribution/Complaints/PMS/Changes

15:45

Device perspective on reusable device

Nicolas Brandes, West

16:30

Global perspective on Device Combinations

Speaker invited, Amgen

17:15

Panel Discussion

17:45

End of Day 1 Lee H. Leichter, RAC, MBA, President P/L Biomedical

Lee Leichter has over 40 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 20. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. Serving as an independent expert on ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices and Human Factors committees, he assists in establishing international standards for safety and performance of these products. He initiated, and leads the ISO Workgroup developing a standard for On Body Delivery Systems (OBDS). His education includes a Bachelor’s degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast University. Lee is currently certified in USA and EU Regulatory Affairs from RAPS and was certified as a Quality Engineer from ASQ. pda.org/EU-UPS2017

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WORKSHOP AGENDA

Friday, 10 November 2017

8:30 – 17:00

Technical Considerations During Drug Device Combination Products Development 8:30

Development and testing for success in multiple jurisdictions

Mark Chipperfield, Corvus Device

9:00

How can pharma benefit from a well-defined and robust delivery device platform

Thomas Schoenknecht, SHL

9:45

Platform Technology

Ian Thompson, Ypsomed

10:15

Coffee Break Human Factors Considerations

10:45

US FDA Position/Expectations

Irene Chan, FDA

11:15

MHRA Position/Expectations

Elizabeth Baker, MHRA (invited)

11:45

Industry Perspective

Muriel Didier, Novartis

12:15

Panel Discussion

12:45

Lunch Break Life Cycle Management Activities of Drug Device Combinations [eg. Changes, PMS, …..]

13:45

Company position – ISO Standard – Risk based approach to combination product change management

Suzette Roan, Biogen

14:15

PMS - EU

Elizabeth Baker, MHRA (invited)

14:45

Discussion

15:15

Coffee Break

15:45

Risk Management – Activities during development and Life Cycle Management

Alice Maden, BD

16:15

Using risk management to establish product risk benefit as part of the Development process per ISO 14971 , ICHQ9 and future GMP Annex 1

Horst Koller, HK Packaging

16:45

Processes/systems for Risk Based Decisions for Specification etc.

Lee Leichter, P/L Biomedical

17:15

End of Workshop Manfred Maeder, PhD, Head Device Development & Commercialization of BTDM, Novartis

Since 2015 Manfred Maeder is Head Device Development & Commercialization of BTDM (Biologics Technical Development and Manufacturing) at Novartis. Before that he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development starting in 2011. Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs at Ypsomed. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site.

Before then, being based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products.

Prior to that, he held several positions in QA and QC. By training he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.

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9 S U X9 IT H IS T V OO B

AT

TAKE THE POD CHALLENGE

Visit Insulet’s booth and see why the Omnipod® is trusted by more than 100,000 people every day.

For every demo Insulet will donate $5 to the Juvenile Diabetes Research Foundation For more details on how Omnipod® Delivery Systems can work for you, call +1 978-600-7000 or visit www.insulet.com

Insulet Corporation Ranked #4 on Forbes 2017 The World's Most Innovative Growth Companies List

© 2017 Insulet Corporation. Omnipod and the Omnipod logo are trademarks or registered trademarks of Insulet Corporation. All rights reserved. Forbes is a registered trademark of Forbes Media LLC. 19320-5A-AW R1 09/2017

what’s next?

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INFORMATION CO N TAC T I N FO R M AT I O N Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Registration Customer Care Tel: +49 30 4365508-10 registration-europe@pda.org Education Program Inquiries Elke von Laufenberg training-europe@pda.org Exhibition/Sponsorship Inquiries Nadjeschda Gomez-Stahl expo-europe@pda.org GENER AL ADDRESS PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66

VENUE Austria Center Vienna Bruno-Kreisky-Platz 1 A-1220 Vienna www.acv.at How to find the Venue:

AUSTRIA CENTER VIENNA Š Google – For directions click on the picture, scan the QR-code or go to

https://goo.gl/maps/oHDeG

H OT E L ACCO M M O DAT I O N PDA Europe is cooperating for hotel accommodation with:

If you have any questions regarding hotels or reservations, please get in touch with optiMICE directly.

Contact: Sven Wilfling; swilfling@opti-MICE.de optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017. We recognize that attendees have many options with area hotels and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

Special offer: Discounted travel with Lufthansa Group Airlines Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lh.com/event-flight-booking and enter the access code DEZJPAN in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available.

Please note that Exhibition Housing Services (EHS) do not represent PDA Europe or its events, nor have we authorized them to use our name or trademarks on information they send out to exhibitors and participants. If you are contacted by EHS using our name or the name of our events, offering advertising space in Event-Fair Guides, website or hotel reservation services, please do neither respond nor sign anything.

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These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the access code as a reference.

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The Universe of Pre-filled Syringes & Injection Devices

Registration Form Page 1

7–8 November 2017 | Vienna | Austria

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.

Your registration is only complete upon filling in and submitting both pages of this form.

1

Registration

LATE REGISTRATION FEE: All registrations received after 3 November will be subject to a 200€ late fee All fees given in Euro, excluding VAT (20%)

Pre-Conference Workshop Innovative Drug Delivery Sytems / Combination Products 6 November

795

All Participants

Pre-Conference Workshop Impact of Pre-filled Syringe Packaging Components for Biopharmaceuticals 6 November

All Participants

795

All Participants

795

Pre-Conference Workshop Connected Health & Drug Delivery 6 November

Conference

The Universe of Pre-filled Syringes & Injection Devices

PDA Member

7–8 November

* Regulatory Early Bird 850 €

Nonmember

Regulatory, Academic

2295

950*

1995

**

Discount for Exhibiting Companies

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1345 € per ticket. No further discounts are applicable with this option (as PDA Membership discount or Group Ticket discount).

One-Day Training Course 9 November

Container Closure Development

Two-Day Training Course 9–10 November

Best Practices and Points to Consider in Aseptic Processing

Two-Day Training Course 9–10 November

Rapid Microbiological Methods

Two-Day Training Course 9–10 November

Container Closure Integrity Testing

Two-Day Training Course 9–10 November

Development and Manufacturing of Pre-filled Syringes

Two-Day Workshop 9–10 November

Drug Delivery Sytems: Global Technical, Regulatory and Quality Challenges

All Participants

845

All Participants

1495

All Participants

1495

All Participants

1495

All Participants

1495

All Participants

1495

The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.

Conference Registration Fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies). **

Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free.

For more information on group discounts please contact Antje Petzholdt at petzholdt@pda.org. Other discount cannot be applied.

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Registration Form Page 2

The Universe of Pre-filled Syringes & Injection Devices 7–8 November 2017 | Vienna | Austria

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.

3 WAYS TO REGISTER

1 ONLINE: pda.org/EU-UPS2017 2 FAX: +49 30 436 55 08-66 3 EMAIL: registration-europe@pda.org

1 Your Contact Information

If this form is an update to a previously submitted form, please check here.

Mr.

Ms.

Dr.

I want to become a PDA Member.

Please send me a subsription form

Nonmember PDA Member

Name (Last, First, MI) *

ID Number

Job Title * Company*

Department

Mailing Address City

Postal Code

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Email *

Business Phone

Fax

Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the member ship fee.)

* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

2 Information about Visa Matters

• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.

• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)

• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

3 Payment Options

By Bank Transfer Beneficiary: PDA Europe gGmbH IBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

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This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)

Your registration is only complete upon filling in and submitting both pages of this form.

Date

Mandatory Signature

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 10 September 2017, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

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51

PDA Europe Conference, Exhibition, Education

Parenteral Packaging The Parenteral Drug Association presents:

Container CIosure Best Practices Throughout the Product Life Cycle

MARK YOUR CALENDAR

27-28 February 2018 Marriott Rome Park Hotel Rome | Italy

NE W

The single-use, large volume wearable injector.

Pre-filled and pre-assembled for easy patient training and use Attach, inject and dispose for simple and ergonomic handling Clearly communicates via audio and visual signals before, during and after injection Sterile ready-to-fill cartridge and needle unit for easy drug filling and final assembly Unique electromechanical drive system offers flexibility for a range of viscosities and fill volumes

For more information visit www.ypsomed.com/yds Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland T +41 34 424 41 11 // info@ypsomed.com

2017 PDA EUROPE CONFERENCES 10-11 October

Pharmaceutical Cold & Supply Chain Logistics

Prague, Czech Republic

7-8 November

The Universe of Pre-filled Syringes and Injection Devices

Vienna, Austria

21-22 November

Outsourcing & Contract Manufacturing

Munich, Germany

2018 PDA EUROPE CONFERENCES 27-28 February

Parenteral Packaging

Rome, Italy

15-16 May

Virus Forum

Florence, Italy

29-30 May

Pharmacopoeia Conference

Vienna, Austria

5-6 June

Advanced Therapy Medicinal Products

Amsterdam, The Netherlands

26-27 June

3rd PDA Europe Annual Meeting

Berlin, Germany

September

Vaccines

Location TBC

11-12 September

Pharmaceutical Freeze Drying Technology

Munich, Germany

11-12 September

11th Workshop on Monoclonal Antibodies

Munich, Germany

Events with additional Education Program. More information – http://t1p.de/7p9z

15-16 October

Pharmaceutical Microbiology

Berlin, Germany

23-24 October

Visual Inspection Forum

Berlin, Germany

6-7 November

Outsourcing & Contract Manufacturing

Location TBC

6-7 November

Pharmaceutical Cold Chain & Supply Chain Logistics

Location TBC

Subject to change

For latest info: pda.org/pda-europe

Shortlist 6 Oct 2017

Events with additional Education Program. More information – www.pda.org/pda-europe

Connecting People, Science and Regulation®

General Information PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66 info-europe@pda.org

pda.org/ pda-europe