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
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Activities at a Glance
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Pre-Conference Workshops
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Venue 11 Main Event
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Letter from the Chairs
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Conference
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Conference Agenda
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Exhibition Floor Plan
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PDA Education Program
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Training Course Agendas
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General Information
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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
PHARMA
DU
AL
STRY IN
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. 8
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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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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
pda.org/EU-UPS2017
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
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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
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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
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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.
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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.
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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
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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
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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
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© 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
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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.
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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) *
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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.)
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Your registration is only complete upon filling in and submitting both pages of this form.
Date
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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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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