2017 2nd PDA Europe Annual Meeting

The Parenteral Drug Association presents:

2nd PDA Europe Annual Meeting Global Healthcare of the Present & the Future

13-14 June 2017 Hilton Berlin Berlin | Germany

LETTER FROM THE CO-CHAIRS Dear Colleagues, SCIENTIFIC PROGR AM PL ANNING COMMIT TEE

Stephan Rönninger, Amgen, Chair Véronique Davoust, Pfizer, Co-Chair Ivo Backx, Siemens Borke van Belle, Janssen J&J Mario Bott, Fraunhofer IPA Tor Gråberg, AstraZeneca Maik Jornitz, G-CON Manufacturing Toni Manzano, BigFinite Yves Mayeresse, GlaxoSmithKline Mike Morris, Ext. HPRA Chris Procyshyn, Vanrx Pharmasystems Ryan Smith, Sight Machine Falk Klar, PDA Europe Georg Roessling, PDA Europe

On behalf of the scientific program planning committee, we would like to invite you to the 2nd PDA Europe Annual Meeting held in Berlin / Germany, 13-14 June 2017.

The topic of this Annual Meeting is Global Healthcare of the Present & the Future, spanning a bridge between current demands in the global healthcare industry, big data issues as well as promising personalized medicine and medicinal products.

The meeting will also include presentations from regulatory, industry and technology representatives from around the world.

A comprehensive exhibition including a Poster Session to catch up on the latest developments will give you the opportunity to network and interact with speakers and fellow attendees.

As customary for PDA, the event will be accompanied by an excellent Education Program, with a Workshop on Annex 1 and a training on Aseptic Processing Principles - just to name some of the highlights.

Check the schedule on the next page for a detailed overview of all events.

We look forward to meeting you in Berlin!

Stephan Rönninger, Amgen, Conference Chair

2

pda.org/eu-AnnualMeeting2017

Véronique Davoust, Pfizer, Conference Co-Chair

S C H E D U L E AT A G L A N C E 12 June

9:00 – 18:00

Quality by Design (QbD) for Biopharmaceuticals

Training Course

12 June

10:00 – 17:00

Revision of Annex 1

Pre-Conference Workshop

12 June

13:00 – 17:00

Business Opportunities Iran

Pre-Conference Workshop

12 June

9:00 – 18:00

Cleaning and Disinfection

Training Course

13 June

9:00 – 18:30

2nd PDA Europe Annual Meeting

Conference, Exhibition

13 June

19:00 – 22:30 Networking Event at “Pier 13”

14 June

8:30 – 16:00

2nd PDA Europe Annual Meeting

Conference, Exhibition

15 June 16 June

9:00 – 18:00 9:00 – 17:00

Introduction to Aseptic Processing Principles

Training Course

15 June 16 June

9:00 – 17:45 9:00 – 16:30

Practical Approach to Quality Culture

Training Course

For latest information, please visit: pda.org/eu-AnnualMeeting2017

pda.org/eu-AnnualMeeting2017

3

PRE CONFERENCE AGENDA

Revision of Annex 1 Monday, 12 June 2017 10:00

Welcome

10:00 – 17:00 Falk Klar, PDA Europe Gabriele Gori, GlaxoSmithKline Vaccines

Opening: Regulatory Update: Revision of Annex 1 10:10

Regulatory Perspectives on Inspectional Findings and the Revision of the EU GMP Annex 1

Andrew Hopkins, MHRA

10:40

Inspector’s Perspective: Needs for Annex 1 Revision

Beate Reutter, Landesamt für Soziale Dienste

11:10

Q&A, Urgent Questions for Regulators

11:20

Coffee Break & Exhibition

Session 1: Quality Risk Management for Aseptic Processing

Moderator: Vincent O’Shaughnessy, Amgen

11:50

QRM and the Aseptic Processing Control Strategy

Kelly Waldron, Val Source

12:10

Risk Based Process Design for a Sterile Suspension

Geert Vandenbossche, Novartis

12:30

Roundtable Discussion: Identifying Key Questions for Regulators

12:50

Panel Discussion with Regulators

13:10

Lunch Break & Exhibition

Session 2: Contamination Control: From Cleanroom to Isolator

4

Moderator: Gabriele Gori, GlaxoSmithKline Vaccines

14:10

Advanced Aseptic Manufacturing with Barrier Systems Annex 1’s Impact in the Fill / Finish Process Environment

14:30

Roundtable Discussion: Identifying Key Questions for Regulators

14:50

Panel Discussion with Regulators

15:10

Coffee Break & Exhibition

pda.org/eu-AnnualMeeting2017

Moderator: Gabriele Gori, GlaxoSmithKline Vaccines Johannes Rauschnabel, Robert Bosch GmbH

PRE CONFERENCE AGENDA

Session 3: Contamination Control: Container Closure Systems

Moderator: Geert Vandenbossche, Novartis

15:40

Meaningful Control Strategy for Container Closure Integrity

16:00

Roundtable Discussion: Identifying Key Questions for Regulators

16:20

Panel Discussion with Regulators

16:40

Summary Remarks

Derek Duncan, LIGHTHOUSE

Falk Klar, PDA Europe Gabriele Gori, GlaxoSmithKline Vaccines

17:00

End of Workshop

pda.org/eu-AnnualMeeting2017

5

PRE CONFERENCE AGENDA

Business Opportunities Iran Following the success of the first PDA Conference in Teheran (Iran) in September 2016, PDA Europe is organizing the workshop “Business Opportunites In Iran” previously to the 2nd PDA Europe Annual Meeting. This workshop has been specially designed for companies interested in establishing business contacts in Iran and sharing information to further develop successful collaborations. The workshop will feature several speakers from different companies and institutions and will foster personal exchange within its participants.

Monday, 12 June 2017 Welcome & Introductions Pharmaceutical Landscape in Iran

Farzad Peiravian, IFDA invited Georg Roessling, PDA Europe Moderator: Georg Roessling, PDA Europe

Regulatory Perspective & Regulatory Framework

Farzad Peiravian, IFDA invited

Doing Pharma Business in Iran Experiences of a European Company

Saad Moimini, Novo Nordisk

The Iranian Pharma Industry Opportunities in Post-Sanctions Era

Alireza Zahraee

Update on PICs

Zohre Bazaz, IFDA

Technology Trends

Moderator: Georg Roessling, PDA Europe

Modern Concepts of Primary Packaging - Ready to fill Concept

Lorenza Bonaldi, OMPI

Visible Particulate Matter Control Strategy – USP <1790>

Oliver Valet, rap.ID

Benefits of Modularity and Rapid Bio-Decontamination for Processing in Small Scale Aseptic Filling Line

Paolo Liverani, Getinge

Product Portfolio and Trends

Christa Janssen-Otto, West

Q&A, Discussion with Exhibitors and Conference Participants 15:45

Coffee Break & Exhibition Equipment and Manufacturing Machines Solutions with Multi-Use Filling Lines

Basem Gerges, Optima

Non-destructive, Deterministic Inspection Technologies for CCIT on Ampoules, IV Bags and the Trends for Vials and Syringes

Jaime Cobo, Wilco

Title to be confirmed

Michael McGowan, SHL

Q&A and Panel Discussion with Exhibitors and Conference Participants 18:00 6

Moderator: Georg Roessling, PDA Europe

End of Workshop

pda.org/eu-AnnualMeeting2017

The Parenteral Drug Association presents:

2017 PDA Europe Conference, Exhibition

Outsourcing & Contract Manufacturing

Register by 24 Sep 2017 and SAVE!

pda.org/EU-Outsourcing2017

21-22 November 2017 Roomers Design Hotel Munich | Germany

CONFERENCE AGENDA

Tuesday, 13 June 2017 9:00

8

Welcome & Introductions Opening Remarks & PDA Interactive: Quo Vadis, Pharma Industry?

Falk Klar, PDA Europe

Keynote 9:30

Current Political Landscape and the Future of Our Industry

Martin Lush, NSF Health Sciences

Opening Plenary

CURRENT DEMANDS

10:00

International Regulations of Pharmaceuticals in the Future

Emer Cooke, WHO

10:30

GMP Harmonisation - Challenges and Opportunities

Paul Hargreaves, MHRA / PIC/S

11:00

Medical Products & Regulatory System in Iran

Rassoul Dinarvand, IFDA

11:30

Coffee Break, Poster Session & Exhibition

12:00

Challenges in Vaccines Development and Manufacturing

12:30

Q&A, Discussion

13:00

Lunch Break, Poster Session & Exhibition

pda.org/eu-AnnualMeeting2017

Stephan Roenninger, Amgen Véronique Davoust, Pfizer Anja Ebers, Meeting Facilitator

Moderator: Stephan Roenninger, Amgen

Rahul Singhvie, Takeda

CONFERENCE AGENDA

PAR ALLEL TR ACKS Session 1

TRACK A

TRACK B

TRENDS IN MODERN ENGINEERING

HUMAN FACTORS

Engineering has always been an applied science, improving technology to deliver cost effective and optimal solutions. New factories and old are built and retrofitted to become more flexible in all of the operations involved. Different tools are available and can be activated to achieve this goal: new operational models, single-use systems, continuous processing and modular approaches. A comparison of different cleanroom designs with the associated benefits and drawbacks will be presented in this session.

The world becomes increasingly digital, and also in manufacturing, all the processes along the lifecycle need to become more interconnected. Digital simulation and modelling of any future project helps evaluate the potential for improvement. Feasibility studies, through commissioning, plant management and even maintenance and service need to be made interdependent. Integration allows not only an increase in efficiency, but also a reduction in cost and improvement in overall process and product quality.

All these topics will be discussed in detail during this session.

The human factor in relation to pharmaceutical products deserves an end-to-end focus. Providing solutions for patients and healthcare workers requires full understanding of the user-to-product interface, the patient’s condition and application conditions. This information and insight needs to be built into the product during Research and Development. On the other hand, Good Manufacturing Practices and regulatory expectations applying to supply and distribution chains safeguard the companies and patients through a number of preventive requirements and corrective controls to manage potential impact of the human factor. In this session, we will focus on this end-to-end view, and learn how the patient as ultimate customer is centric in understanding the human factor as being key for the success of a pharmaceutical product.

Moderator: Yves Mayeresse, GSK

Moderator: Borke Van Belle, Janssen J&J

Comparison of Cleanroom Designs & Structures Cost and Benefit Review

User Centered Design: Exploring Physical Capabilities of Intended Users

Maik Jornitz, G-CON Manufacturing

Nicholas Stones, Novartis

Flexibility by Design – Flexibility and Innovation in Facility Design for Manufacturing of Tomorrow’s Vital Biopharmaceutical Products

The Patient Perspective

Alex Severin, NNE

Jez Clements, Cambridge Design Partnership

From Integrated Engineering to Integrated Operation

How Mixed Reality Will Drive the Future of Drug Delivery Product Development

Fabio Paganelli, Siemens

Serge Dubeau & Matt Gottschalk, Worrell

15:30

Q&A, Discussion

Q&A, Discussion

16:00

Coffee Break, Poster Session & Exhibition

14:00

14:30

15:00

pda.org/eu-AnnualMeeting2017

9

CONFERENCE AGENDA

PAR ALLEL TR ACKS Session 2

TRACK A

TRACK B

SECURING THE SUPPLY CHAIN

MANAGING THE QUALITY-COST DILEMMA

Quality requirements in the supply chain are increasing in an effort to prevent counterfeits and drug shortages. This session will focus on and provide an insight on how risk of drug shortages can be addressed and what manufacturers can do. A tool for managing single and multi-source challenges for drug availability will provide a practical example on how manufacturers and/or Marketing Authorization holders but also wholesalers can manage continued supply. Finally, we will receive an overview on current expectations on the distribution of medicines, highlighting pitfalls from an inspector’s point of view.

Is there any contradiction between quality and cost? Or is it simply the way that lack of quality will immediately increase the cost? This potential dilemma will be scrutinized in conjunction with the importance of Quality Culture both from an industry perspective as well as the view of regulators.

Attendees will gain an understanding of the importance to facilitate quality in combination with cost awareness as well as the paramount need for a clear Quality Culture.

Moderator: Stephan Roenninger, Amgen

Moderator: Tor Gråberg, AstraZeneca

Managing Single- and Multi-Source Supply Chain Challenges: A Practical Tool

Total Cost of Quality: Speaking Business Language

Emma Ramnarine, Genentech / Roche

Borke van Belle, Janssen J&J

Reducing Risk of Drug Products Shortages

Developing a Culture of Quality

Yvonne Stewart, GSK

Frederik Åsell, AstraZeneca

Experience with GDP Inspections

Are Quality Costs Fully Calculable?

A GMP-Inspector’s View

Terence Madigan, MHRA

Rainer Gnibl, District Government of Upper Bavaria

18:00

Q&A, Discussion

Q&A, Discussion

18:30

End of Day 1 & Networking Event at Pier13

16:30

17:00

17:30

2017 PDA Europe Annual Meeting Speakers https://goo.gl/P8bVvI

Summer in Berlin nd a B PDA g Live! in Play anged by H ea d

b

PLEASE JOIN US FOR OUR NETWORKING EVENT AT “PIER 13”, TUESDAY, 13 JUNE 2017 Meeting Point: Hilton Berlin Hotel Lobby 19:00 - Shuttle Bus leaving 19:30 - Dinner & Party 22:30 - Shuttle Bus returning to the Hotel

CONFERENCE AGENDA

Wednesday, 14 June 2017 7:30

PDA Orientation Breakfast

8:30

Welcome Coffee, Poster Session & Exhibition

PAR ALLEL TR ACKS Session 3

TRACK A

TRACK B

ADVANCED ASEPTIC PROCESSING & ENVIRONMENTAL MONITORING

CONNECTIVITY, SMART DEVICES & ANALYTICS

With the increased focus on advanced processes, the limits of traditional environmental monitoring methods are being stretched. Experts from a range of companies will provide insight into their experiences with new monitoring technologies, as well as the practical implementation of these technologies into new automated, closed aseptic processes. Attendees will gain an understanding of the regulatory implications and a view to the future.

Do we know the real implication of the digital transformation in the industry? Industrial Internet of Things or Machine to Machine are terms that begin to sound familiar in pharma and that are a reality in the health, automotive and energy sectors. When the cloud concept is added to these ingredients, new concerns arise. The industrial digitalization obviously requires innovative technology, but also a new mindset able to advance people into a new generation driven by connectivity: the era where existing knowledge becomes part of production.

Moderator: Christopher Procyshyn, Vanrx

Moderator: Toni Manzano, Bigfinite

Continuous Microbiological Monitoring for Aseptic Manufacturing

Driving Digital Transformation: Best Practices for Realizing Value from New Technology within your Organization

Jeffrey Weber, Pfizer

Ryan Smith, Sight Machine

New Advanced Aseptic Filling Technology in a New Greenfield Manufacturing Facility

Digital Transformation Systems in Healthcare

Aidan Harrington, DPS Engineering

Saso Jezernik, Altran

Repeatable H₂O₂ Measurement during Bio-Decontamination: Measurement Tech­ nology, Relative Humidity vs. Relative Saturation and Material Selections

Internet of Things for Predictive Analytics

Irene Zakrzewski, Vaisala

Wim De Bruyn, Ghent University

10:30

Q&A, Discussion

Q&A, Discussion

11:00

Coffee Break, Poster Session & Exhibition

9:00

9:30

10:00

12

pda.org/eu-AnnualMeeting2017

CONFERENCE AGENDA

PAR ALLEL TR ACKS Session 4

11:30

12:00

12:30

TRACK A

TRACK B

FACILITY DESIGN & MODELLING

CONNECTIVITY, HANDLING BIG DATA & DATA MANAGEMENT

Moderator: Mike Morris, exHPRA

Moderator: Ryan Smith, Sight Machine

Organising the Interface between GMP and GCP for Production and Clinical Application of Advanced Cell and Gene Therapeutics

Big Data, Internet of Things, Machine Learning, Artificial Intelligence: How to Transform Pharma Manufacturing & Biotech Processes

Lutz Uharek, Charité Berlin

Thomas Unger, Bigfinite

Process Design – Migration to a Modelling Based Workflow

From Bits to Bedside: Developing a Learning Digital Health System to Evaluate Pigmented Skin Lesions

Mateusz Landowski, DPS Engineering

Dexter Hadley, University of California, San Francisco

Risk-based Tools for Designating Appropriate Room Classification for Biopharmaceutical Operations in Conceptual Design

Discovering Novel Biomarkers by Robotic Molecular Diagnosis

Lars Hovmand-Lyster, Novo Nordisk

Nathan Boley, DRIVER

13:00

Lunch Break, Poster Session & Exhibition

Closing Plenary

TECHNOLOGIES & PHARMA OF THE FUTURE

14:00

Light and Life: How Spectroscopy Supports the Life Sciences

Jürgen Popp, Leibniz Institute of Photonic Technology

14:30

Reimbursement and Cost of Quality

Richard Brand, BeyondSpring Pharma

15:00

Panel Discussion

Richard Brand, BeyondSpring Pharma

Quo Vadis, Pharma Industry?

Paul Hargreaves, MHRA

• Global Disease Management and Medicines, Challenges,

Moderator: Véronique Davoust, Pfizer

Demands & Future Opportunities • Insurance & Coverage, Novel Technologies, Funding & Availability • Paradigm Shifts: Interconnect R&D, Industry, Patient & Payers

Richard Johnson, PDA Martin Lush, NSF Health Sciences Yves Mayeresse, GlaxoSmithKline Christopher Procyshyn, Vanrx Lutz Uharek, Charité Berlin

16:00

Closing Remarks End of Conference & Farewell

Falk Klar, PDA Europe Stephan Roenninger, Amgen Véronique Davoust, Pfizer pda.org/eu-AnnualMeeting2017

13

EXHIBITION

CURRENT DEMANDS, UNDERSTANDING MANUFACTURING & MODERN ENGINEERING, SECURING THE SUPPLY CHAIN, USING MODELLING TO ENHANCE UNDERSTANDING, HUMAN FACTORS, CONNECTIVITY, HANDLING BIG DATA & DATA MANAGEMENT, MANAGING THE QUALITY-COST DILEMMA, MEDICINAL PRODUCTS

2 DAYS CONFERENCE MORE THAN 300 ATTENDEES

TRAININGS: CLEANING & DISINFECTION/ SUPPLY CHAIN STRATEGIES FOR API AND DRUG PRODUCT/ QUALITY BY DESIGN FOR BIOPHARMACEUTICALS/ INTRODUCTION TO ASEPTIC PROCESSING PRINCIPLES/ QUALITY CULTURE

EXHIBITION WITH SOLUTION PROVIDERS FROM AROUND THE GLOBE

AUTHENTIC NETWORKING OPPORTUNITIES IN THE HEART OF BERLIN

TO E X H I B IT: 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 2.495 Euro net (table-top).

For more information please contact expo-europe@pda.org 14

pda.org/eu-AnnualMeeting2017

FLOOR PLAN - HILTON HOTEL BERLIN

35 34 PDA Lounge

39

Table Top 2 m x 2 m (4m2) PDA Registration/Lounge Catering Poster Session

33

41

32 19 17

30

23

29 24 27

25 16

TO CONFERENCE

22

Poster Session

15

11 12

14

9 Catering

8 7

TO CONFERENCE

13

10

6 5 PDA

1

2

3

ENTRANCE

pda.org/eu-AnnualMeeting2017

15

Training & Education Program europe.pda.org

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 experts Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation Customized in-house training courses and workshops available

PDA Education Program 12 June 2017 Quality by Design (QbD) for Biopharmaceuticals One-Day Training Course 12 June 2017 Cleaning and Disinfection One-Day Training Course 15 – 16 June 2017 Introduction to Aseptic Processing Principles Two-Day Training Course 15 – 16 June 2017 Practical Approach to Quality Culture Two-Day Training Course

ONE-DAY TRAINING COURSE

Quality by Design (QbD) for Biopharmaceuticals A practical approach

Overview The principles and practices of Quality by Design (QbD) for biopharmaceutical, biosimilar, and other biologic manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), identification of critical quality attributes (CQAs) and justification of critical process parameters (CPPs). The principles and practices of QbD are applicable for both in-house and contracted-out biopharmaceutical development, manufacturing and testing.

Unfortunately, there is so much confusion today about what QbD is and isn’t: What is so different about QbD? Must QbD include a thorough multi-variate analysis of design space? Does QbD guarantee regulatory freedom to independently make future manufacturing process changes? Does QbD mean no future manufacturing problems?

Before launching into QbD, biopharmaceutical manufacturers must first have a firm understanding of the unique challenges facing biologics, and then a complete understanding of the International Council on Harmonization (ICH) strategic guidances (Q8, Q9, Q10, Q11) for this enhanced approach.

Practical suggestions to help your company apply QbD to your biopharmaceutical, biosimilar or other biologic development program will be provided by examining what has worked already for other companies. The six (6) key steps of QbD will be examined and discussed carefully. Also, this course will identify the limitations of the QbD approach.

Who Should Attend:

Learning Objectives:

This course is designed specifically for those involved or interested in an enhanced control system for biopharmaceuticals, including

Upon completion of this course, you will be able to:

• • • • • •

Senior Management Directors and Managers/Supervisors QA/QC Regulatory Affairs Manufacturing Process Development

•

Explain the importance and underlying principles of an effective QbD approach for biopharmaceuticals, biosimilars and other biologics

•

Gain a firm understanding to apply the principles of QbD to all types of biologic products – recombinant proteins, monoclonal antibodies, biosimilars, gene therapy products and cell-based medicines

John Geigert, PhD, BioPharmaceutical Quality Solutions John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. He has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biotech Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics (2nd Edition). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic / Analytical Chemistry from Colorado State University.

18

pda.org/eu/QBD2017

TRAINING COURSE AGENDA 7 June 2017

Monday, 12 June 2017

9:00 – 18:30

9:00

Welcome & Introduction

9:10

Applying QbD Requires Understanding the Challenges Due to the Complexity of Biologics

10:30

Coffee Break

11:00

Applying QbD Requires Understanding the Systematic Principles Laid Out in ICH Q8, Q9, Q10 and Q11 – Quality Risk Management, Knowledge Management

12:30

Lunch Break

13:30

Six Steps to an Effective Implementation of a Biopharmaceutical Control System

15:00

Coffee Break

15:30

Practical Examples Illustrating Successfully Applied QbD For Biopharmaceuticals

18:30

End of Course

pda.org/eu/QBD2017

19

TRAINING COURSE AGENDA 7 June 2017

Monday, 12 June 2017 9:00

Welcome & Introduction

Module 1: Outsourcing Strategies for EU and US 9:15

• • • •

How to set up your strategy?

When is the right time for outsourcing?

Which are the key-aspects to be considered at different stages of development?

What is essential from a GMP and regulatory perspective in EU and US?

10:45

Coffee Break

Module 2: Process Transfers of Drug Substances & Drug Product 11:15

• • • •

How to plan a Process Transfer?

What are the essential parts of Technology Transfer Package?

How can you minimize Risks and Delays?

Typical Examples (Drug Substance, Tablets, Sterile Product)

12:45

Lunch Break

Module 3: Workshop: Project Management for a Typical Technology Transfer Project 13:30

• • •

Planning Key-Milestones Documentation

15:15

Coffee Break

Module 4: Outsourcing: QC and QA-Perspective 15:30

• • • • •

When will you outsource analytics and why?

How will you choose your Contract Lab? What are the points to be considered for an analytical transfer?

What needs to be considered for the GMP-Agreement?

What is essential for inspections?

Module 5: Outsourcing: Success Factors

20

16:30

• • • •

How will you select and evaluate your potential partners?

How will you monitor the transfer activities?

How will you cope with unplanned changes?

How can you manage your project successfully?

17:15

Summary of the Day

17:30

End of Training Course

pda.org/eu/supplychain-api

9:00 – 17:30

ONE-DAY TRAINING COURSE

Cleaning and Disinfection A practical approach Overview This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The information shared will encompass regulatory aspects, Environmental Monitoring, contamination sources, selection of disinfectants and cleaning agents, the validation and how they should be used properly.

Who Should Attend:

Learning Objectives:

• • • •

At the end of the workshop attendees should be able to develop or evaluate an existing cleaning and disinfection program in line with regulatory expectations and facility’s requirements for contamination control of classified areas.

Production management Operators responsible for/involved in C&D Quality/Microbiology management Quality personnel involved in C&D

Monday, 12 June 2017 9:00

9:00 – 18:00

Welcome & Introduction Subject Introduction | General Framework | Directives | Guidelines | Expectations

10:30

Coffee Break Environmental Monitoring and Risk Analysis | Root Cause of Contamination

12:30

Lunch Break

13:30

Selection Criteria | Validation | Means and Methods

15:30

Coffee Break Practical Approach | Supplies and Tools | Case Studies

18:00

End of Training Course

Peter Koger, MSc., Technical Sales Manager International, Veltek Associates Inc. Peter Koger has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects related to Aseptic Manufacturing and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice level in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is Technical Sales Manager responsible for Europe and part of Asia. pda.org/cleaning-and-disinfection2017

21

TWO-DAY TRAINING COURSE

Introduction to Aseptic Processing Principles Overview This course is intended to provide individuals with an understanding of the fundamental principles governing aseptic processing.

The course will cover the systems associated with aseptic processing and how they work together to help ensure a sterile product.

The Key Topics are:

• • • • • • •

Facility/Equipment/Process Design Environmental Monitoring Gowning/Aseptic Technique Sterilization Cleaning and Disinfection Process Simulations (Media Fills) Recent Regulatory Activity

Who Should Attend:

Learning Objectives:

This course is ideal for those who are either new to the industry or new to aseptic processing.

Participants from disciplines such as mechanics, HVAC technicians, cleaning and disinfection personnel, and microbiology technicians will also benefit from this course even if they are minimally involved in the aseptic manufacture of drugs, but need to understand the systems associated with it.

Upon completion of this course, you will be able to:

• Be able to describe some of the critical elements (“Hot Topic”) associated with aseptic processing

• Be able to discuss basic concepts of cleanroom operation and monitoring

• Have an understanding of the current regulatory concerns and industry interpretations of the regulations

Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe, and has been engaged in more than 30 projects: recently at US- Lachman Consultants as “Aseptic Processing Expert”, e.g. in assignments for remediation of companies cited with a Warning letter.

In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic Processing key elements, training and motivation of operators, media fill practices of finished dosage forms and bulk products, environmental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits. He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years.

Since 2017 he is also a member of the 2017 PDA Annex 1 Workshop committee and Task Force, which deals with the revision of the important European guidance Eudralex Annex 1 “Manufacture of Sterile Medicinal Products”. 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.

22

pda.org /eu/TCAseptic2017

TRAINING COURSE AGENDA 7 June 2017

Thursday, 15 June 2017 9:00

9:00 – 18:00

Introductions / Scope • Welcome & Introduction • Aseptic Processing vs. Terminal Sterilization • Describe the importance of each component of aseptic processing • Discuss how the components of aseptic processing are interrelated

Friday, 16 June 2017 9:00

9:00 – 17:00

Environmental Monitoring • Environmental monitoring techniques for various applications.

• Discuss choosing monitoring locations.

• Discuss alert and action limits.

Coffee Break

Facility Design / HEPA Filters / Differences between Isolators and Conventional Processing • Identify key components of facility design and controls • Define regulatory requirements of critical and clean area control parameters • Discuss HEPA filter construction / function / testing • Identify differences between aseptic processing in isolators and conventional lines

CIP / SIP / Depyrogenation • Describe how CIP and SIP can lower risk of contamination and minimize manual interventions • Identify key CIP / SIP process steps and types of equipment that can be CIP / SIP’d • Discuss principles of depyrogenation and its importance to injectable products

Coffee Break

Aseptic Processing Simulation Studies (Media Fills) • Review background and objective of APS • Review elements of study design • Best practices how to keep overview of routine operations and media fills • Brief Introduction to the usage of Risk Assessments for making better decisions

Working in Unidirectional Flow and Good Aseptic Working Practices • Describe concepts of airflow and “first air” • Understand risk of product contamination when not following first air principles • Real- Life examples about good and bad practices in cleanrooms (videos / pictures) Lunch Break Basic Microbiology • Describe qualities and types of microorganisms • Describe modes of microorganism transport • List growth requirements and sources • Explain methods and importance of identification • Introduction to Pharmaceutical Water Systems: what are the contaminations risks and points to consider in monitoring

Lunch Break

Coffee Break Regulatory Trends and a Summary of Hot Topics in Aseptic Processing • Recent trends in regulatory citations End of Training Course

Coffee Break Cleaning and Disinfection / Bio-Decontamination • List appropriate application methods • Describe the importance of cleaning and disinfection • Understand the basis of chemical selection use and application • Detail the proper order of cleaning • Describe bio-decontamination methods for isolator / barrier systems Gowning, Personnel Qualification and Aseptic Technique and Cleanroom Behavior • Explain acceptable personnel behavior • Discuss what should be included in personnel qualification program • Describe why training and qualification minimize contamination End of Day 1

pda.org /eu/TCAseptic2017

23

TWO-DAY TRAINING COURSE

Practical Approach to Quality Culture Overview A good quality culture is established when all employees starting from CEO to shop floor workers are accountable for quality.

The following attributes are important indicators for quality culture: management communication emphasizing that quality is everyone’s responsibility, established quality improvement objectives, quality topics included in relevant meetings, and an implemented error prevention process.

These quality attributes are related to management responsibility and are elements of the continuous improvement of the pharmaceutical quality system as mentioned in the ICH Q10 guideline.

Quality culture is a key management element for success. However, quality culture does not establish itself but requires empowerment, communication and daily quality awareness.

Who Should Attend:

Learning Objectives:

Functions:

This training course is interactive, hands-on, and will empower you to measure, develop and improve the quality culture of your company:

• • • • • •

Middle Management Managers with employee responsibility Group Leaders Department Heads Directors Executive Level

•

Learn to measure quality attributes and quality behaviors

•

Identify weaknesses and deficits in quality behavior

•

Investigate root causes and define effective CAPAs for improvement

•

Optimize your measures with respect to cost, time and quality

Departments: • • • • • • • •

Quality Assurance Quality Control Production Purchasing Regulatory Affairs R&D Human Resources Controlling

Thomas Krieger, PhD, KU-Pharma Consulting Thomas Krieger is founder and CEO of Krieger Unternehmensberatung - Pharma (KU-Pharma) since 2009. KU-Pharma is mainly specialized on providing quality consulting for the pharmaceutical industry. In addition, KU-Pharma is providing career-readiness-training to high-potentials and coaching to managers who take on new tasks or assume new legal functions according to the drug law. Thomas studied pharmacy and obtained his Ph.D. degree in Pharmaceutical Chemistry from the University of Tuebingen, Germany. He graduated as specialized pharmacist of Pharmaceutical Analysis. Since 25 years he holds the legal qualification and has professional experience as a Qualified Person pursuant to Directive 2001/83/EC. During 20 years Thomas Krieger has held different legal functions according to the drug law and various senior management and leadership positions in quality control, quality assurance, regulatory affairs and scientific departments. He worked for several pharmaceutical companies within the range from Global Players with more than 50,000 employees to private owned companies with less than 100 employees.

Martin Haerer, Senior Director R&D/Qualified Person,Holopack Verpackungstechnik GmbH After the Ph.D. in Pharmacy, Martin started his career at Holopack Verpackungstechnik in 1990. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production. In 2006 he was appointed Production Manager and Qualified Person. Currently he is responsible for Business Development, Technology Transfer and Research, and still acting as Qualified Person with QA responsibilities. Martin was voted Member of the Board of the BFS-IOA Association as Regulatory Officer. He is member of the German QP Association and Board Member of Federal German Pharmacist Advanced Training Organisation (BAK).

24

pda.org/eu/quality-culture2017

TRAINING COURSE AGENDA 7 June 2017

Thursday, 15 June 2017

9:00 – 17:45

Friday, 16 June 2017

9:00 – 16:30

9:00

Welcome & Introduction

9:00

Recap of Day 1

9:10

Lecture 1: Definition: What Does Quality Mean?

9:15

Interactive Session 4: Exercise

9:30

Interactive session 1: Where Do We Find Quality Culture?

10:00

9:45

Lecture 2: Quality Behaviors • What are quality behaviors?

• What are “good” quality behaviors?

• What are “bad” quality behaviors?

• How are they measured?

Lecture 5: Principles of CAPA • What are effective CAPA? • What are efficient CAPA? • How and when to measure effectiveness of CAPA? • What to do in case of re-occurrence?

11:00

Coffee Break

11:30

Interactive session 5: Exercise

12:15

Lecture 6: Cost-Time-Quality Dilemma • Total quality cost • Develop understanding for triangle Cost-Time-Quality • What is the “ideal” point within that triangle?

• What are the consequences of the 3 extreme positions [Point A: 0% Time and cost, 100% quality; Point B: 0% time and quality, 100% cost, Point C: 0% cost and quality, 100 % time] • Value of well-done investigations

13:00

Lunch Break

14:00

Lecture 6 (cont.): Cost-Time-Quality Dilemma • Review CAPA from interactive session 5 in terms of cost

14:30

Lecture 7: What is an Ideal Quality Culture in a Company?

15:15

Interactive Session 6: Exercise

16:15

Q&A

16:30

End of Training Course

10:30

Interactive session 2: Quality Behavior with Interactive Exercise

10:45

Coffee Break

11:15

Interactive Session 3: Assessment Exercise • Self-assessment of own company • Interpretation of PDA survey results • What does this result mean for pharma industry in general?

12:15

Lunch Break

13:15

Lecture 3: Investigation Principles • Which functions should be in the investigation team?

• Which skills are necessary for investigation team members?

• How to identify the root cause?

• What is the right extend and width of an investigation?

14:45

Coffee Break

15:15

Lecture 4: Toolbox for Improvement of Quality Behaviors • Communication • Risk management • Project management • Stakeholder analysis • SIPOC method • KPI/quality metrics • Fishbone diagram • 5 W questions • Fault tree • Advantage and disadvantage of tools

17:45

End of Day 1

pda.org/eu/quality-culture2017

25

HILTON HOTEL BERLIN

INFORMATION

VENUE Hilton Berlin Mohrenstraße 30 10117 Berlin Germany Tel: +49 30 20 23 00 http://hilton-berlin.hotel-in-berlin.org/

GENER AL ADDRESS PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66

Special Rates PDA Europe has reserved a limited number of bedrooms until the 14 May 2017. Book your group rate for PDA. Single Room 189€ per room and night Double Room 209€ per room and night Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.

S PEC I A L R E QU I R E M E N T S If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration-europe@pda.org

D I R EC T I O N S

HILTON HOTEL BERLIN

© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/7g4fN3ARyGk

CO N TAC T I N FO R M AT I O N Registration Customer Care Tel: +49 30 4365508-10 registration-europe@pda.org

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 DEZJPRG 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.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

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.

Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Education Program Inquiries Elke von Laufenberg training-europe@pda.org Exhibition / Sponsorship Inquiries Nadjeschda Gomez-Stahl expo-europe@pda.org pda.org/eu-AnnualMeeting2017

27

2nd PDA Europe Annual Meeting

Registration Form Page 1

13-14 June 2017 | Berlin | Germany

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 All fees given in Euro, excluding VAT (7 %)

13-14 June

Conference only

Conference Fee

2nd PDA Europe Annual Meeting

PDA Member

1595

**Nonmember

1895

* Early Bird 700 â&#x201A;Ź **Regulatory/Academic

800

Poster Presenter please mark here (written approval required, conference fee applies) 12 June

Pre-Conference Workshop

Revision of Annex 1

12 June

Pre-Conference Workshop

Business Opportunities Iran 12 June

One-Day Training Course

One-Day Training Course

Two-Day Training Course

Introduction to Aseptic Processing Principles 15-16 June

695

Nonmember

895

Workshop Fee

Two-Day Training Course

Practical Approach to Quality Culture

295

Training Course Fee All Participants

Quality by Design for Biopharmaceuticals 15-16 June

PDA Member

All Participants

Cleaning & Disinfection 12 June

Workshop Fee

845

Training Course Fee All Participants

845

Training Course Fee All Participants

1495

Training Course Fee 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. **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 registration-europe@pda.org. Other discounts cannot be applied.

Discount for Exhibiting Companies

Join PDA and receive the Membership Rate Today!

Please go to: www.pda.org/membership

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1250 Euro per ticket.

No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

28

pda.org/eu-AnnualMeeting2017

2nd PDA Europe Annual Meeting

Registration Form Page 2

13-14 June 2017 | Berlin | Germany

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-AnnualMeeting2017 2 FAX: +49 30 4365508-66 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

Country

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

Your Company VAT I.D.:

By Credit Card

Purchase Order

American Express

MasterCard

VISA

Purchase Order Number

For your credit card information safety: Please send your details by fax only.

Billing Address:

Same as contact information address above.

If not, please send your billing address to: registration-europe@pda.org PDA Europe VAT I.D.: DE254459362

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 13 May 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 registration-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.

pda.org/eu-AnnualMeeting2017

29

2017 PDA EUROPE CONFERENCES 30 May – 1 June

Virus & TSE Safety Forum

Dubrovnik, Croatia

13 – 14 June

2nd PDA Europe Annual Meeting

Berlin, Germany

27 – 28 June

Advanced Therapy Medicinal Products

Valencia, Spain

19 – 20 September

Pharmaceutical Freeze Drying Technology

Cologne, Germany

26 – 27 September

Particles in Injectables

Berlin, Germany

26 – 27 September

10th Workshop on Monoclonal Antibodies

Berlin, Germany

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

Subject to change

For latest info: pda.org/pda-europe

Shortlist 7 June 2017

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

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

Connecting People, Science and Regulation ®

www.pda.org/pda-europe