Outsourcing & Supply Chain A 360 View

Transcription

1 PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: Outsourcing & Supply Chain A 360 View 6-7 November 2018 Hotel Meliá Sevilla Seville Spain

2 LETTER FROM THE CHAIR Dear Colleagues, On behalf of the program planning committee, please be invited to join us for the PDA Europe Conference Outsourcing and Supply Chain - A 360 View, to take place in Seville, Spain, 6-7 November SCIENTIFIC PLANNING COMMITTEE Allison Hardy, Eli Lilly, Conference Chair Firelli Alonso, Pfizer Henry Ames, Sensitech Christoph Antz, European Institute for Pharma Logistics Katherine Brandt, Afton Scientific Xavier Duburcq, Altran Richard Harrop, Topa Packaging Gregor Kawaletz, IDT Biologika Holger Memmesheimer, Boehringer-Ingelheim Siegfried Schmitt, PAREXEL Elisabeth Vachette, Sartorius Stedim Kerstin Wilken, PDA Europe Teresa Schubach, PDA Europe, Manager Programs & Events This newly designed conference will cover the whole supply chain from raw materials to last-mile distribution. One main topic of this event will be the interaction and dependencies between all the functions involved, such as developers, suppliers, manufacturers, logistics providers and storage companies, as well as testing labs. Only a few big players can execute all these functions with their own resources the reality has proven that smaller companies must partner with other companies to succeed. With this conference, PDA offers a new platform for all professionals involved in this field to explore and discuss new developments and opportunities. Join us and be a part of this exciting interaction! We look forward to welcoming you to Seville! Sincerely, Allison Hardy, PhD, Eli Lilly, Conference Chair 2 pda.org/eu/2018outsourcing

3 SCHEDULE AT A GLANCE 6 November 9:00 18:15 Outsourcing & Supply Chain Conference, Exhibition 6 November 18:45 21:45 Networking Event 7 November 9:00 16:30 Outsourcing & Supply Chain Conference, Exhibition 8 November 9 November 9:00 17:30 9:00 16:30 Risk Management in Technology Transfer Training Course 8 November 9 November 9:00 18:00 9:00 16:30 Practical Guide for Root Cause Investigations Training Course For latest information, please visit: pda.org/eu/2018outsourcing WELCOME TO SEVILLE pda.org/eu/2018outsourcing 3

4 CONFERENCE AGENDA 30 Oct 2018 Tuesday, 6 November :00 Welcome and Introduction Kerstin Wilken, PDA Europe Allison Hardy, Eli Lilly, Conference Chair Session 1 Outsourcing in the Midst of Increasing Complexity Moderator: Firelli Alonso, Pfizer The KISS Principle states that most systems work best if they are kept simple rather than made complicated; therefore, simplicity should be a key goal in design, and that unnecessary complexity should be avoided. However, this remains to be a real challenge in the world of biologics and pharmaceuticals, be it for animal pharma, for maintenance of data integrity in complex supply chains, or for sourcing of complex medicines, like antibody-drug conjugates. Listen to what these experts have to say, and how they have overcome this challenge! 9:15 Outsourcing of Pharmaceutical Development in Animal Health - A Comparison with Human Pharma 9:45 Effective GxP Data Integrity Governance in Complex Supply Chains 10:15 Challenges and Successes in the Externalization of the ADC Supply Chain Monika Brink, Boehringer Ingelheim Rachel Carmichael, NSF Health Sciences Firelli Alonso, Pfizer 10:45 Q&A, Discussion 11:00 Coffee Break, Poster Session & Exhibition Session 2 Supply Chain Management Moderator: Henry Ames, Sensitech We are so used to supply chains running smooth and extremely fast at least this is our private home experience. Now, the real world for pharmaceuticals looks very, very different. The challenges are formidable: temperature controls, traceability, prevention of theft and fraud, or simply getting a single vial to a patient in a far-flung corner of this world. The presenters have a wealth of practical experience and will show how these obstacles can be overcome, for the benefit of all patients. 11:30 How Patient Centricity Changes the Clinical Supply Chain Andrea Zobel, PAREXEL 12:00 More Confidence Less Paper How Digitalization of Environmental Monitoring in Your Supply Chain Can Help Increase Your Efficiency 12:30 Practical Issues Around Protection of Cargo on the Tarmac at an Airport Markus Haase, Testo Steve Brabbs, DuPont 13:00 Q&A, Discussion 13:15 Lunch Break, Poster Session & Exhibition 4 pda.org/eu/2018outsourcing

5 CONFERENCE AGENDA Session 3 Speed Business Exchange 14:15 Open to all exhibitors and conference attendees: Responding to a growing demand in having better opportunities for professional networking, PDA offers this special session to connect solution seekers with solution providers. Participants: Contract manufacturers: Contract testing labs: Supply Chain Handling: contract giver / contract acceptor contract giver / contract acceptor contract giver / contract acceptor Click Mark here your and preference mark your for preference the Speed Business for the Speed Exchange Business directly Exchange on directly on the Registration Form. Save and to registration-europe@pda.org 15:45 Coffee Break, Poster Session & Exhibition Session 4 Regulatory Perspectives Moderator: Allison Hardy, Eli Lilly 16:15 CGMPs for the Outsourced Pharmaceutical Supply Chain Kathleen Culver, US FDA 16:45 Risks in the Supply Chain from the Inspector s Perspective Manuel Ibarra, AEMPS 17:15 Learnings from Outsourcing Arrangements: The Regulations, Operational Challenges and Opportunities Paula Katz, Covington & Burling 17:45 Panel Discussion 18:15 End of Conference Day 1 18:45 Networking Event pda.org/eu/2018outsourcing 5

6 The Parenteral Drug Association is proud to invite you to a very special Networking Dinner. Tuesday, 6 November :45 Meeting Point: Hotel Lobby Joint Walking Tour and Sightseeing in Seville 19:45 Dinner, Ristorante La Raza, Avda. Isabel the Catholic 2, Seville 21:15 Walking Tour back to Conference Hotel Join us for a fabulous evening in a traditional Spanish Restaurant. Restaurant La Raza: In the park of Maria Luisa, opposite the Casino Exhibition and Teatro Lope de Vega, surrounded by extensive vegetation and several outdoor terraces, is a privileged place in the city that has become a benchmark for an evening out in Seville. 6 pda.org/eu/2018outsourcing

7 CONFERENCE AGENDA Wednesday, 7 November 2018 PARALLEL TRACKS Session 5 Track A Tech Transfer Track B Transportation and Cold Chain Distribution 9:00 Following approval, products have to be manufactured on a large scale up to hundreds and thousands of batches per year. To ensure market supply, complex supply chains often include different internal and external sites that need to be established. Robust developed products and reliable and efficient transfer processes are the cornerstone to deliver high quality medicines to the patient. In this session we will learn from experts more about challenges and success factors in this surrounding. 9:00 Technology Transfer: Learn the Journey about Strategy, Risk Analysis, Process Flow and Tips to Achieve an Efficient Transfer Olivier Michel, Altran 9:30 Improving Product Quality During Technical Transfers Eric Good, ProPharma Group 10:00 Tech Transfer Standard Work for Success Integration of Value Stream Mapping and Risk Assessments with Tech Transfer Rachael Atlee, Merck Moving products through a distribution chain can present many challenges in terms of thermal and physical damage to pharmaceutical products, and any protective shipping solutions used to limit this impact need to be fully understood in terms of their capabilities. Within this session our speakers will explore new product innovations designed to reduce product damage, present insights into best practices for the qualification of solutions and share news of an industry wide collaboration, who are publishing guidelines for the effective return and reuse of cold chain solutions. How to Speed Up Process Validation for Bulk Drug Substances Transportation Elisabeth Vachette, Sartorius Stedim Biotech Active Systems Qualification - Family Approach Eric Stener, Sanofi Pasteur Industry Collaboration: Return & Reuse - Best Practice Guidance Anthony Rizzo, Cold Chain Technologies 10:30 Q&A, Discussion Q&A, Discussion 10:45 Coffee Break, Poster Session & Exhibition Session 6 Track A Trends in Digitalization Track B Case Studies 11:15 We have moved past the point where businesses can consider digital opportunities as an option to a situation today where digital know-how is essential as a core competency. In this session we will explore 3 practical applications, starting with the digital twin of a manufacturing plant and its benefits, followed by the impact of digitalization on outsourcing strategies and the supply chain, and finally an evaluation of the impact of virtual cold chain to improve line risk assessments. Accelerated growth and demand in drug supply has prompted the development for more complex networks composed of multiple entities with many new challenges. Case studies presented in this session provide concepts, strategies and practical insights either from a CMO or a contract giver perspective which have been successfully implemented. pda.org/eu/2018outsourcing 7

8 CONFERENCE AGENDA 11:15 The Factory of the Future: How a Digital Twin of your Plant will Help You to Increase the Industrial Performance Valerio Di Giovanni, Altran 11:45 Digitalization and its Impact on Outsourcing Strategies and the Supply Chain Chances and Risks Natascha de Raad, Med-X-Press 12:15 How the Virtual Cold Chain can Improve Lane Risk Assessment Stefan Braun, SmartCAE Realizing the Benefits of Single-Use in BioPharm. Manufacture Philip Hall, Fujifilm Diosynth Biotechnologies A Global Single-Use Platform Approach Sonja von Orlikowski, Boehringer Ingelheim Case Study on Delegating Supplier Management Responsibilities to your CM Partner William J Campagna Jr, Eli Lilly 12:45 Q&A, Discussion Q&A, Discussion 13:00 Lunch Break, Poster Session & Exhibition Closing Challenges in Commercial Contract Manufacturing Choosing the right CMO for a specific need can be a demanding task. Once the partner is identified, establishing a good working relationship and ensuring the quality oversight throughout the process may ensue specific challenges. In this session the speakers will present their approaches and ideas on this essential topic in contact manufacturing. 14:00 Contract Manufacturing - Moving from Oversight to Partnership Models 14:30 The Use of Contract Services for the Quality Oversight of Complex Supply Chains Sarah Hockey, Novartis Neil Raw, Raw Quality Associates 15:00 Coffee Break, Poster Session & Exhibition 15:30 Development Meets Routine Manufacturing Robustness of Inhalation Products Holger Memmesheimer, Boehringer Ingelheim 16:00 The Journey to Succeed: Choosing your CDMO Damaso Molero, 3P Biopharmaceuticals 16:30 Closing & End of Conference Allison Hardy, Eli Lilly, Conference Chair Kerstin Wilken, PDA Europe 8 pda.org/eu/2018outsourcing

9 FLOOR PLAN to Conference Afton 17 Table Top 2 m x 3 m (6 m 2 ) Catering PDA Registration Onset Topa FedEx and TNT PDA Sensitech POSTER SESSION Testo 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 gomez@pda.org pda.org/eu/2018outsourcing 9

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11 PDA Education Program 8-9 November 2018 Risk Management in Technology Transfer Two-Day Training Course 8-9 November 2018 Practical Guide for Root Cause Investigations Two-Day Training Course

12 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-18

13 TRAINING COURSE AGENDA 30 Oct 2018 Thursday, 8 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, 9 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-18 13

14 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. 14 pda.org/eu/rootcause2018

15 TRAINING COURSE AGENDA Thursday, 8 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, 9 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/rootcause

16 INFORMATION VENUE Meliá Seville Calle Dr. Pedro de Castro Sevilla Spain Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. DIRECTIONS GENERAL ADDRESS PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: 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 highlyqualified, 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 Teresa Schubach 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 gomez@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 DEZJEGJ 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. 16 pda.org/eu/2018outsourcing

17 HEADERHEADLINE Uninterrupted monitoring - with a single system testo Saveris Pharma Solutions: Assist you with the comprehensive monitoring of all audit-relevant parameters and measurement data. Reduce human error sources and improve control along the value chain. Enable timely intervention in the event of deviations before they have any far-reaching consequences. pda.org/eu/2018outsourcing 17

18 Outsourcing & Supply Chain A 360 View Reg Form Page November 2018 Seville Spain 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 (21 %) 6-7 November Conference only Conference Fee Outsourcing & Supply Chain A 360 View PDA Member 1595 Nonmember 1895 Regulatory/Academic 800 Poster Presenter please mark here (written approval required, conference fee applies) 8-9 November Two-Day Training Course Training Course Fee Practical Guide for Root Cause Investigations All Participants November Two-Day Training Course Training Course Fee Risk Management Technology Transfer All Participants 1495 Contract Manufacturer looking for a solution offering solutions Contract Testing Lab looking for a solution offering solutions Supply Chain Handling looking for a solution offering solutions Your consent is important. We manage your personal data responsibly. For more information, please visit pda.org/privacy-policy RESPONSE REQUIRED By checking the box(es) below, I consent to: My contact information (name, company, job title, city, state, country) being printed on the attendee list distributed at the event. PDA recording and/or photographing me and using those recordings and/or photographs in future PDA promotional and marketing materials. PDA sending me promotional information via . PDA sending me promotional information via post The fee includes event 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 petzholdt@pda.org. Other discounts cannot be applied. 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 1095 per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). 18 pda.org/eu/2018outsourcing

19 Reg Form Page 2 Outsourcing & Supply Chain A 360 View This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 3 WAYS TO REGISTER ONLINE: pda.org/eu/2018outsourcing FAX: registration-europe@pda.org 6-7 November 2018 Seville Spain 2 Your Contact Information If this form is an update to a previously submitted form, please check here. Mr. Ms. Dr. Nonmember I want to become a PDA Member. Name (Last, First, MI) PDA Member ID Number Job Title Company Department Mailing Address City Postal Code Country Business Phone Substituting for Fax (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) 3 4 Information about Visa Matters Payment Options 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). By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D Berlin, Germany By Credit Card American Express MasterCard VISA For your credit card information safety: Please send your details by fax only. Purchase Order Purchase Order Number Billing Address: Same as contact information address above. If not, please send your billing address to: petzholdt@pda.org Your Company VAT I.D.: This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) PDA Europe VAT I.D.: DE 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 payment 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 23 September 2018, 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. Onsite 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 pda.org/eu/2018outsourcing 19

20 P D A E U R O P E E V E N T S 6-7 November Outsourcing & Supply Chain - A 360 View Seville, Spain 22 November Project Management in the Pharmaceutical Industry Berlin, Germany November Pharmaceutical Freeze Drying Technology Seville, Spain November 11 th Workshop on Monoclonal Antibodies Seville, Spain 11 December Annex 1 Workshop Berlin, Germany P D A E U R O P E E V E N T S March Parenteral Packaging Venice, Italy May Pharmacopoeia Geneva, Switzerland 4-5 June Advanced Therapy Medicinal Products Vilnius, Lithuania June 4 th PDA Europe Annual Meeting Amsterdam, The Netherlands 3-4 September BioManufacturing Berlin, Germany September Pharmaceutical Freeze Drying Technology Berlin, Germany September Particles in Injectables Berlin, Germany 8 October Project Management in the Pharmaceutical Industry Berlin, Germany October The Universe of Pre-filled Syringes and Injection Devices Gothenburg, Sweden Subject to change For latest info: europe.pda.org Shortlist 30 Oct 2018 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: info-europe@pda.org europe. pda.org