Outsourcing & Contract Manufacturing

Transcription

1 The Parenteral Drug Association presents: 2017 PDA Europe Conference, Exhibition Outsourcing & Contract Manufacturing Getting it Right Throughout the Manufacturing Lifecycle pda.org/eu-outsourcing November 2017 Roomers Design Hotel Munich Germany

2 LETTER FROM THE CHAIR Dear Colleagues, The PDA Europe Outsourcing & Contract Manufacturing conference has been taking place since 2015 and has become a not-to-be-missed event for any professional interested in the field. This year s event will take place from November in Munich, Germany. By featuring different industry approaches, the program focuses on the question of how to successfully collaborate on outsourcing of pharmaceutical products or services. Presentations come from large and small pharma companies, small biotech, academia and governmental representatives, and are based on different case studies, which will provide insights into the elements needed for establishing an effective pharmaceutical development and manufacturing partnership. New types of collaborations and solutions will be presented, and engaging talks by internationally recognized experts will make this an exceptional event. Join us this fall in Munich! Firelli Alonso, PhD, Pfizer Conference Chair SCIENTIFIC PLANNING COMMITTEE 1 Firelli Alonso, Pfizer, Chair 2 Katherine Brandt, Afton Scientific 3 Klaus Buchweitz, Novartis 4 Allison Hardy, Eli Lilly 5 Kim Hejnaes, Hejnaes Consult 6 Gregor Kawaletz, idt Biologika 7 Siegfried Schmitt, PAREXEL 8 Kerstin Wilken, PDA Europe 2 pda.org/eu-outsourcing2017

3 SCHEDULE AT A GLANCE 21 November 9:00 17:30 Outsourcing & Contract Manufacturing Conference, Exhibition 21 November 18:30 21:30 Networking Dinner 22 November 9:00 16:00 Outsourcing & Contract Manufacturing Conference, Exhibition 23 November 24 November 9:00 17:30 9:00 16:30 Risk Management in Technology Transfer Training Course 23 November 24 November 9:00 18:00 9:00 16:30 Practical Guide for Root Cause Investigations Training Course 23 November 24 November 9:00 17:15 9:00 16:45 Outsourcing, Technology Transfer, and CMO-Client Relationships Training Course pda.org/eu-outsourcing2017 3

4 CONFERENCE AGENDA Tuesday, 21 November Nov :00 Welcome and Introduction Kerstin Wilken, PDA Europe Firelli Alonso, Chair, Pfizer Session 1: Global Regulatory Trends in Outsourcing & Contract Manufacturing Moderator: Firelli Alonso, Pfizer 9:10 Flexibility by Design Morten Munk, NNE 9:40 The Role of Organizational Culture in the CMO Selection Process - Are there criteria for a best fit? Michael Walliser, Conscious Performance 10:10 Coffee Break, Poster Session & Exhibition 10:40 QbD in the Development and Validation of Analytical Methods Holger Memmesheimer, Boehringer Ingelheim 11:10 Person in Plant Vincent Bille, Marble Pharma 11:40 European Political Landscape in Light of BREXIT Allison Hardy, Eli Lilly 12:10 Q&A, Discussion 12:30 Lunch Break, Poster Session & Exhibition 13:30 Panel Discussion: Join us for an after-lunch exchange and get to some of the root topics and key issues in Outsourcing! Moderator: Morten Munk, NNE 1) Data & Information Sharing: Best Practice Tools to Ensure Efficiency, Security & Safety 2) Best Practice in Continuous Manufacturing for Legacy Products 3) Artificial Intelligence & Smart Learning Systems in Manufacturing 4) Cell & Gene Therapies - Axenic Manufacturing & Annex 1 Revision Session 2: Contract Manufacturing & Outsourcing Case Studies Moderator: Gregor Kawaletz, idt Biologika 14:00 How to Safely Handle and Transport Bulk Drug Substances: Outsourcing as a Tool for Enhanced Confidence in Liquid BDS Handling Strategies Elisabeth Vachette, Sartorius Stedim FMT SAS 14:30 Data Integrity in CMO & Case Study Silke Schumacher, Novartis 15:00 Coffee Break, Poster Session & Exhibition 15:30 Case Studies of Existing and New US Combination Product Approaches Brian Bird, Novartis 16:00 Flexibility During Early Stage Technology Transfer A Case Study Jaby Jacob, Kemwell Biopharma 16:30 Q&A, Discussion 17:00 Summary & End of Day 1 17:30 Networking Dinner 4 pda.org/eu-outsourcing2017

5 CONFERENCE AGENDA Wednesday, 22 November 2017 Session 3: Effective Oversight of Operations: Different Perspectives Moderator: Allison Hardy, Eli Lilly 9:00 Challenges in CMC Outsourcing Kim Hejnaes, Hejnaes Consult 9:30 Auditing of the Manufacturing Operation David Fisher, Eli Lilly & Co. 10:00 Coffee Break, Poster Session & Exhibition 10:30 Auditing from a CMO Perspective Jessica Walker, Afton Scientific 11:00 Oversight of the Contract Manufacturer from a CMO Perspective Neil Raw, Vectura 11:30 Q&A, Discussion 12:00 Lunch Break, Poster Session & Exhibition The Parenteral Drug Association is proud to invite you to a very special Networking Dinner Join us for a fabulous evening in a traditional Bavarian restaurant! Tuesday, 21 November 18:30h Meeting Point: Hotel Lobby Joint Bus Transfer 19:00h Augustiner Klosterwirt Augustiner Strasse 1, München 21:30h End of Networking Dinner Dress Code: casual proudly supported by Afton Scientific cgmp Processing of Sterile Products

6 PDA INTERACTIVE Session 4: PDA Interactive: Knowledge Meets Discussion Moderator: Kerstin Wilken, PDA Europe Committee members and selected speakers will facilitate lively discussions and exchange around a choice of controversial key issues. Results will be collected and presented as a summary at the end of the day. 13:00 Roundtable Discussions: Participants will rotate every 30 min. Each moderator will prepare a short summary of the discussions and present it to the audience DISCUSSION 1 DISCUSSION 2 DISCUSSION 3 QUALITY AGREEMENTS: How much detail does a quality agreement need? DATA INTEGRITY: How to raise awareness in our companies? MULTI PRODUCT FACILITIES: Change Over, Cleaning, Hazardous Materials, Viral Vectors Moderators: Allison Hardy, Eli Lilly Klaus Buchweitz, Novartis Moderators: Katherine Brandt, Afton Scientific Silke Schumacher, Novartis Moderators: Fi Alonso, Pfizer Kim Hejnaes, Consultant 13:10 GREEN GROUP RED GROUP BLUE GROUP 13:40 RED GROUP BLUE GROUP GREEN GROUP 14:10 BLUE GROUP GREEN GROUP RED GROUP 14:45 Coffee Break & Exhibition 15:15 Summary of Discussions, Q&A Committee Members and Moderators 16:00 Closing Comments & Farewell Kerstin Wilken, PDA Europe 6 pda.org/eu-outsourcing2017

7 FLOOR PLAN ROOMERS DESIGN HOTEL Table Top 2 m x 2 m (4m 2 ) Catering PDA Registration PDA CATERING CONFERENCE ROOM NIPRO 4 Conference Afton PQE CATERING Entrance 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 Euro net (table-top). For more information please contact expo-europe@pda.org pda.org/eu-outsourcing2017 7

8 PDA HEADERHEADLINE Europe Conference, Exhibition, Education The Parenteral Drug Association presents: Parenteral Packaging Container CIosure Best Practices Throughout the Product Life Cycle MARK YOUR CALENDAR February 2018 Marriott t Rome Park Hotel Rome Italy 8 pda.org/eu-outsourcing2017

9 PDA Education Program November 2017 Risk Management in Technology Transfer Two-Day Training Course November 2017 Outsourcing, Technology Transfer, and CMO-Client Relationships Two-Day Workshop November 2017 Practical Guide for Root Cause Investigations Two-Day Training Course

10 TWO-DAY TRAINING COURSE Risk Management in Technology Transfer The Most Important Aspects of PDA Technical Report # 65 Overview Nowadays technology transfer projects are a reality in the pharma markets. For several reasons, manufacturing process and related activities (i.e. analytical, development, quality, operation excellence) are moved intra companies and inter companies. Due to the high number of risks associated with the safe robust and in compliance manufacturing of a drug, an appropriate risk management approach and appropriate skills have to be in place in the transferring and receiving site. Following the main international guidance, such as technical report 65 and ICH, this workshop will guide the attendees through a technology transfer process and its risk management and provide insights and practical guidance for developing internal robust procedures, skills and approaches. Who Should Attend: Subject matter experts coming from different areas such as Production QA Validation Engineering (involved in process/equipment design) RA QC (involved in analytical transfer) Project Managers and Technology Transfer Managers are key Learning Objectives: Understand principles, main documents and main steps of a technology transfer process (internal and external) Identify risks in technology transfer processes Evaluate risks and put in place appropriate mitigation plan Understand main roles and responsibilities of the stakeholders of technology transfer process Create high level internal procedures for handle technology transfer Mirko Gabriele, Global Technology Transfer Senior Manager, Patheon Mirko joined Patheon in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager and Manager of Technology Transfer Responsibility for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies. Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July pda.org/eu/risk-tt-17

11 TRAINING COURSE AGENDA 16 Nov 2017 Thursday, 23 November :00 17:30 9:00 Welcome & Attendees Introduction 9:00 Technology Transfer Definition and Main Principles Opportunities along product lifecycle Regulatory guidance on technology transfer Planning and Social Intelligence Tool for planning 10:00 Technology Transfer Definition and Main Principles (continued) Tool for Social Intelligence Role and responsibility General org chart in technology transfer 11:00 Coffee Break 11:30 Technology Transfer Project Management Tools Timelines Leadership Communication 12:30 Lunch Break 13:30 Technology Transfer Documentation Technology Transfer Plan Technology Transfer Report Feasibility batches Protocol and Report 14:30 Technology Transfer Procedures 15:30 Coffee Break 16:30 Analytical Transfer General approach (transfer vs validation) Analytical Master Plan 17:00 Recap of the Day 17:30 End of Day 1 Friday, 24 November :00 16:30 9:00 Recap of the Main Concepts of Day 1 9:30 Introduction into Technical Report TR 65 Project staging Risks in technology transfer Risk Management in technology transfer 10:30 Introduction into Technical Report TR 65 (continued) Severity/Occurrence/Detection in technology transfer FMEA 11:00 Coffee Break 11:30 TR 65 Case Study 1 Analytical Method Transfer (AMT) Design of Comparative AMT Test Studies Selecting AMT Performance Characteristics AMT Documents 12:30 Lunch Break 13:30 TR 65 Case Study 2 Manufacturing Process Transfer Overvew of Manufacturing Process Transfer Development to Commercialization Technology Transfer Process Intracompany Technology Transfer Process 16:30 End of Course pda.org /eu/risk-tt-17 11

12 TWO-DAY TRAINING COURSE Practical Guide for Root Cause Investigations Methodology & Tool Kit Overview This engaging two-day workshop teaches a step by step, proven process ideal for researching any change/decline in the performance of a product or work process/system, whether it be physical or virtual. It is appropriate for individuals new to this discipline, as well as those who are seasoned veterans looking to improve/refresh their skills, regardless of industry or function within the organization. Simply put, this is one of the most practical and applicable trainings available! On day one, the participants are introduced to the seven step methodology. A Roadmap is provided to guide the participants through the steps and suggest appropriate tools to ensure the right questions are being asked, the right data is being collected, and the right documentation is being made. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strengthening the participants skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team. Participants will be ed a set of electronic templates. These templates, plus the Roadmap, guide the investigator through the methodology and provide the basis for documentation. Who Should Attend: Alumni of this program typically (though not exclusively) have a background in: Quality Risk management Regulatory affairs Compliance Manufacturing Product development CAPA Supply chain & purchasing Production Engineering Project management R&D Fraud management and more Learning Objectives: Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to: Identify the technical root cause(s), that is, the change(s) that occurred. Identify systemic root cause(s), that is, any underlining breakdown in the organizations broader systems that allowed the change(s) to occur. Implement a comprehensive corrective and/or preventive action plan to restore performance. Implement a control plan to minimize and/or prevent recurrence. Rob Weaver, President of Weaver Consulting Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and operations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecommunications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company. 12 pda.org/eu/rci-nov-17

13 TRAINING COURSE AGENDA Thursday, 23 Nov :00 18:00 9:00 Welcome & Introduction Define technical CAPA problem Common investigation mistakes Investigation Roadmap template Introduce 1st participant real life case study 10:00 Step 1: Define the Performance Problem Introduce instructor case study Problem statement Problem description 10:30 Coffee Break 11:00 Step 1: Continued Problem description continued Workshop Flow chart process(es) being investigated & identify key inputs Workshop Time of events Team charter including performance & cost savings goals 12:00 Lunch Break 13:00 Step 2: Collect Data Determine data needed Data collection tools & techniques Data measurement plan Workshop 15:00 Coffee Break 15:30 Step 3: Identify Possible Causes Time of changes Differences between Is & Is Not facts Workshop Changes associated with identified differences Review risk analysis Brainstorming techniques Workshop 16:30 Step 4: Test Possible Causes Test possible causes against facts Summarize testing leveraging contradiction matrix Historical perspective of investigations Workshop 17:30 Step 5: Identify Technical & Systemic Root Causes Verify assumptions Conduct studies/experiments Identify technical root cause(s) Friday, 24 Nov :00 16:30 9:00 Step 5: Continued Identify systemic root causes 9:30 Step 6: Determine Corrective/Preventive Actions Mistake proofing techniques Variation reduction & optimization techniques Corrective/preventive actions Acceptance criteria 10:30 Coffee Break 11:00 Step 6: Continued Risk mitigation Control plan Workshop 11:45 Step 7: Verify Corrective/Preventive Actions Implement & measure corrective/preventive actions Evaluate control plan Determine additional preventive actions 12:00 Lunch Break 13:00 Second Participant Real Life Case Study Introduction Workshop to develop problem statement, problem description, identify possible causes Workshop to collect data Workshop to test possible causes 15:00 Coffee Break 15:30 Second Participant Real Life Case Study Continued Workshop to determine corrective/preventive actions including risk mitigation, control plan, acceptance criteria 16:00 Closing Remarks Compare/contrast this investigation methodology with traditional approach Shortcuts Simple investigations Difficult investigations Investigation report Return on investment References 16:30 End of Course 18:00 End of Day 1 pda.org/eu/rci-nov-17 13

14 TWO-DAY WORKSHOP Outsourcing, Technology Transfer, and CMO-Client Relationships Please Bring Your Laptop Overview A large part of biopharmaceutical companies now rely on outsourcing partners for the development and manufacture of biological drug substance and drug product for clinical studies and commercial supply. The CMC section of a biopharmaceutical project is typically on the time critical path and this can prove a challenge for both the Client (contract giver) and the Contract Manufacturing Organization or CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO. A mutual understanding of risk is a prerequisite for designing the right development and manufacturing program. In addition, a sense of co-ownership of the project adds value in facilitating a seamless contract execution and completion. Topics to be covered: This workshop will discuss the lessons learned from a broad range of biopharmaceutical projects developed successfully by the workshop instructors, who represent both the Client and the CMO sides. The focus of the workshop will be on the key elements to develop a partnership between the parties, covering all phases, from the CMO selection activity, technology transfer of processes and test methods, to project execution including production, testing, and delivery of Clinical Trial Materials (CTM). Additionally, the workshop will include an interactive case study, offering the participants hands-on experience with different CMO selection, risk assessment and mitigation, as well as vendor management tools developed to facilitate cost effective and successful transfer and development of biopharmaceuticals in partnership between the Client and the CMO. Who Should Attend: This workshop is designed for all persons involved in outsourcing activities -- either your job function is on the receiving side (the CMO) or you are representing the contract giver (the Client). Relevant job functions include: Project Management, Process and Analytical Development, Production / Manufacturing, Sourcing, Procurement, Quality Assurance and Control, Business Development, and Senior Management. Learning Objectives: Wear the Hat of a Big Pharma Sponsor in a safe, educational and entertaining environment, allowing you to explore key outsourcing situations in one day, which normally take years to develop. Experience how applying Risk Assessment tools supports the different elements of the process, including: Choose the right CMO, guide you through the contractual agreement, perform technology transfer and produce a clinical batch of monoclonal antibody while keeping within budget and time constraints! Trainers Firelli Alonso, PhD, Senior Director External Supply, Pfizer Jon Crate, Chief Technical Officer, Advantage Analytical Kim Hejnaes, Partner, Hejnaes Consult AB Morten Munk, Global Technology Partner, NNE 14 pda.org//eu/cmo-tt-17

15 WORKSHOP AGENDA 16 Nov 2017 Thursday, 23 November :00 17:15 9:00 Introduction to the Workshop Welcome and introductions instructors & participants Expectations from the workshop Client-CMO relationships 9:30 CMO Selection Process and Tools Selection process parameters Introduction to the CMO selection exercise Morten Munk Firelli Alonso 10:30 Coffee Break 11:00 Group Breakout and Discussion I CMO selection process (50 min) Justification of CMO choice (20 min) 12:30 Lunch Break 13:30 Technology Transfer and Outsourcing Tools Part 1 Process transfer Risk assessment and FMEA Introduction to the FMEA exercise based on CMO choice Kim Hejnaes 14:30 Group Breakout and Discussion II Technology transfer FMEA (45 min) Discussion (15 min) 16:00 Coffee Break 16:30 Closing Remarks Day 1 Lessons learned Participants and instructors feedback 17:15 End of Day 1 Friday, 24 November :00 16:45 9:00 Recap of Day 1 Firelli Alonso, Kim Hejnaes 9:30 Technology Transfer and Outsourcing Tools Part 2 Analytical test methods transfer Introduction to the exercise based on CMO choice Jon Crate 10:30 Coffee Break 11:00 Group Breakout and Discussion III Analytical methods transfer interactive exercise Discussion 12:00 Lunch Break 13:00 Production, Testing, and Delivery of Phase I CTM Project execution and management Introduction to the exercise based on CMO choice Morten Munk 14:00 Group Breakout and Discussion IV Production, testing, and delivery of Phase I CTM Discussion 15:00 Coffee Break 15:30 CMO Performance Management Tools Vendor performance management metrics Firelli Alonso 16:15 Closing Remarks Day 2 Lessons learned 16:45 End of Workshop pda.org//eu/cmo-tt-17 15

16 INFORMATION VENUE Roomers Hotel Munich Landsberger Str München Germany Tel info@roomers-munich.com roomers-munich.com Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. DIRECTIONS HOTEL ROOMERS MUNICH CONFERENCE REGISTRATION HOURS Tuesday, 21 November: 7:00 17:30 Wednesday, 22 November: 7:00 12:00 COURSE REGISTRATION HOURS Thursday, 23 November: 7:00 16:30 Friday, 24 November: 7:00 12:00 TO EXHIBIT: Exhibition and Sponsorship Opportunities are available. 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. Exhibit at PDA events and let your company s products or services become a valuable tool or resource for our attendees. SPECIAL REQUIREMENTS 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. Google For directions click on the picture, scan the QR-code or go to CONTACT INFORMATION Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Registration Customer Care Tel: registration-europe@pda.org Education Program Inquiries Elke von Laufenberg training-europe@pda.org Exhibition/Sponsorship Inquiries Nadjeschda Gomez-Stahl Nadjeschda Gomez-Stahl expo-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 and enter the access code DEZJPAE 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 to lufthansa.mobility@dlh.de and providing the access code as a reference. GENERAL ADDRESS PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: pda.org/eu-outsourcing2017

17 Outsourcing & Contract Manufacturing November 2017 Munich Germany For contact at PDA Europe 3 WAYS TO REGISTER Your Contact Information ONLINE: pda.org/eu-outsourcing2017 FAX: registration-europe@pda.org If this form is an update to a previously submitted form, please check here. Mr. Ms. Dr. Nonmember This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. I want to become a PDA Member. Please send me a subsription form Name (Last, First, MI) * PDA Member ID Number Job Title * Company* Department Mailing Address City Postal Code Country * Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) * This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us. Information about Visa Matters 2 Registration All fees given in Euro and excluding VAT (7 %) Conference (21-22 November) net PDA Member 1495 Nonmember** 1795 Govern./Health Authority/Academic** 750 Poster Presenter please mark here (written approval required, conference fee applies) Two-Day Training Course (23-24 Nov) Risk Management in Technology Transfer All Participants 1495 Two-Day Training Course (23-24 Nov) Practical Guide for Root Cause Investigations All Participants 1495 Two-Day Workshop (23-24 Nov) Outsourcing, Technology Transfer, and CMO-Client Relationships All Participants 1495 **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). 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. 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 us at registration-europe@pda.org. Other discounts cannot be applied. 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 PDA Europe VAT I.D.: DE Billing Address: By Credit Card American Express MasterCard VISA For your credit card information safety: Please send your details by fax only ( ) or register online. By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D Berlin, Germany By Purchase Order Purchase Order Number Your Company VAT I.D.: Same as contact information address above. If not, please send your billing address to: registration-europe@pda.org This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) 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 995 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). This special rate does not include one-year PDA membership. 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 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 21 October 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 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. Organizer: PDA Europe, Am Borsigturm 60, Berlin, Germany pda.org/eu-outsourcing

18 2017 PDA EUROPE CONFERENCES 7-8 November The Universe of Pre-filled Syringes and Injection Devices Vienna, Austria November Outsourcing & Contract Manufacturing Munich, Germany 2018 PDA EUROPE CONFERENCES 26 February 26 February February IG Meeting Pre-filled Syringes IG Meeting Parenteral Packaging Parenteral Packaging IG IG Rome, Italy April Vaccines Location TBC May Virus Forum Florence, Italy May Pharmacopoeia Conference Vienna, Austria 5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands 25 June 25 June 25 June June IG Meeting Visual Inspection IG Meeting Freeze Drying IG Meeting Quality Systems 3rd PDA Europe Annual Meeting IG IG IG Berlin, Germany October Pharmaceutical Microbiology Berlin, Germany October Visual Inspection Forum Berlin, Germany 6-7 November Pharmaceutical Freeze Drying Technology Location TBC 6-7 November 11 th Workshop on Monoclonal Antibodies Location TBC November Outsourcing & Contract Manufacturing Location TBC November Pharmaceutical Cold Chain & Supply Chain Logistics Location TBC Subject to change For latest info: europe.pda.org Shortlist 16 Nov 2017 Events with additional Education Program. More information europe.pda.org Connecting People, Science and Regulation General Information PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: europe. pda.org