3 rd PDA Europe Annual Meeting

Transcription

1 PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: 3 rd PDA Europe Annual Meeting Global Healthcare of the Present & the Future Register by 29 April 2018 and SAVE! pda.org/eu/annual June 2018 Marriott Hotel Berlin Germany

2 LETTER FROM THE CHAIRS SCIENTIFIC PLANNING COMMITTEE Jette Christensen, Novo Nordisk, Conference Chair Borke Van Belle, Janssen J&J, Conference Chair Barbara Allen, Eli Lilly Mario Bott, Fraunhofer IPA Maik Jornitz, G-Con Engineering Aidan Harrington, DPS Engineering Ulrike Malordy, PQE Toni Manzano, Bigfinite Yves Mayeresse, GSK Vaccines Christopher Procyshyn, Vanrx Ryan Smith, Sight Machine Falk Klar, PDA Europe Sylvia Becker, PDA Europe, Manager Programs & Events Dear Colleagues, On behalf of the scientific program planning committee, we would like to invite you to the 3 rd PDA Europe Annual Meeting held in Berlin / Germany, June The ongoing theme of the European Annual Meeting is Global Healthcare of the Present & the Future, as it intends to continue spanning a bridge between current demands within the global healthcare industry, the amounting advanced technological and analytical opportunities and the promising prospects personalized medicine and medicinal products bring. 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 is customary for PDA, the event will be accompanied by Interest Group Meetings, a thorough Education Program, and a diverse Exhibition Floor, offering plenty of food for thought, inspiration and networking opportunity. We look forward to meeting you in Berlin this summer! Sincerely, The Chairs, Jette Christensen, Novo Nordisk, Conference Chair Borke Van Belle, Janssen J&J, Conference Chair 2 pda.org/eu/annual2018

3 MEDIA PARTNER

4 SCHEDULE AT A GLANCE 26 June 9:00 18:00 3nd PDA Europe Annual Meeting Conference, Exhibition 26 June 18:00 22:30 Networking Event 27 June 9:00 16:30 3nd PDA Europe Annual Meeting Conference, Exhibition 28 June 29 June 9:00 17:45 9:00 16:30 Practical Approach to Quality Culture Training Course 28 June 29 June 9:00 17:00 9:00 16:30 Best Compliance Practice in a GMP Regulated Testing Laboratory Training Course 28 June 29 June 9:00 17:45 9:00 15:30 Test-Methods for Pre-filled Syringe Systems Training Course on Twitter and post pictures and highlights of this meeting! #pdaeuannual Follow us on LinkedIn

5 CONFERENCE AGENDA Tuesday, 26 June Mar :00 Welcome & Opening Remarks Introduction & Awards Falk Klar, PDA Europe Jette Christensen, Chair, Novo Nordisk Borke Van Belle, Chair, Janssen J&J Keynotes: Pharmaceutical Industry Highlights - Past, Present, Future 9:15 Sustainable cgmp Compliance is Spelled with 4Cs: Compliance, Culture, Competencies, Capacity Moderator: Borke Van Belle, Chair, Janssen J&J Sanofi Cutting the Gordian Knot How to Tame Rising Operating Model and Manufacturing Complexity The Patient s Perspective: Past, Present & Future of Diagnosis and Therapy Accenture Patient Speaker Q&A, Discussion 11:00 Coffee Break, Poster Session & Exhibition Session 1 International Regulatory Updates Moderator: Jette Christensen, Novo Nordisk 11:30 EMA Update including Annex 1 Revision EMA Speaker, invited PDA Task Force Annex 1 Revision: Industry Comments Activity Update on PUPSIT ValSource GCON Manufacturing Q&A, Discussion 13:30 Lunch Break, Poster Session & Exhibition TRANSITION TO PARALLEL TRACKS Networking Reception 26 June, 18:00h Join us and your colleagues to enjoy drinks and conversation in a casual atmosphere. pda.org/eu/annual2018 5

6 CONFERENCE AGENDA Session 2 TRACK A TRACK B 14:30 Big Data Managing Manufacturing Moderator: Ryan Smith, Sight Machine Big Data Integrity: How to Succeed in the Challenge Using the Cloud Bigfinite Managing the Digital Transformation Industry 4.0 Maturity Center PDA Big Data Task Force Update Pfizer Q&A, Discussion Moderator: Borke Van Belle, Janssen J&J Enabling Agile Digitalization towards Industry / Pharma 4.0 Parametric Technology Process, Product, Patient Advanced Process Control in Manufacturing Janssen J&J A Continuous Improvement Metric for Bio-Pharmaceutical Manufacturing Apotex Q&A, Discussion 16:00 Coffee Break, Poster Session & Exhibition PARALLEL TRACKS Session 3 TRACK A TRACK B 16:30 Engineering Digital Health & Precision Medicine Moderator: Yves Mayeresse, GSK Targeted Innovation Management & Examples in Fill & Finish Janssen J&J Robotic Process Automation (RPA) Novo Nordisk Factories of the Future to Factories of the Here and Now New Generation Biologics DPS Global Q&A, Discussion Moderator: Chris Proceshyn, VanRX Introducing a New Age of User-Centricity - Applying Eye-tracking to the Development of New Combination Products Ypsomed Why Better Human Understanding is the Only Future Greensand Empowering Chronotherapy through Connected Devices and Digital Technologies Altran Q&A, Discussion 18:00 End of Day 1 & Networking Event 6 pda.org/eu/annual2018

7 CONFERENCE AGENDA Wednesday, 27 June 2018 PARALLEL TRACKS Session 4 TRACK A TRACK B 9:00 Smart Industry Regulatory Perspectives Moderator: Toni Manzano, Bigfinite The Smart Industry: An Affordable Reality takes Courage Novo Nordisk The Digital Robot Pharma Factory One One Eleven Smart Packaging as an Enabler for an Outcome Based Healthcare System Schreiner MediPharm Q&A, Discussion Moderator: Barbara Allen, Eli Lilly ICH Q12 and Post Approval Change: PDA Innovation for Availability of Medicines (PAC iam) Novartis & Genentech Establishing Effective Knowledge Management in the Pharmaceutical Industry Amgen Assessing and Improving Quality Culture: Tools and Resources Regulatory Compliance Associates Q&A, Discussion 10:45 Coffee Break, Poster Session & Exhibition PARALLEL TRACKS Session 5 TRACK A TRACK B 11:15 Young Professionals in PDA Data Integrity Moderator: Jette Christensen, Novo Nordisk Moderator: Aidan Harrington, DPS Data Integrity: Eliminating Risk & Human Error in Manufacturing and Laboratory Processes Charles River PDA especially invites young professionals, SMEs and Start-ups to get involved by sharing short presentations. Group Rates are available! Contact us for more information! Data Integrity Governance & Metrics to Mitigate Regulatory Risks Across Corporate Networks PQE Industry Coalition Position Paper on Audit Trail Review Novartis 12:45 Q&A, Discussion Q&A, Discussion 13:00 Lunch Break, Poster Session & Exhibition

8 CONFERENCE AGENDA CLOSING PLENARY 14:00 Future Opportunities and Directions for Pharmaceutical Manufacturing A Global View Future Challenges and Opportunities for Manufacturing Site Operations Pfizer Eli Lilly 15:00 Coffee Break, Poster Session & Exhibition Healthcare of the Future: Multi Organ Chip Technologies TissUse Closing Panel Discussion, Q & A 16:30 Summary, Conclusions Closing Remarks End of Conference & Farewell Coffee Jette Christensen, Novo Nordisk Borke Van Belle, Janssen J&J Falk Klar, PDA Europe 8 pda.org/eu/annual2018

9 PDA Scientific Poster Presentation Exhibit your Work 85 cm (33,4646 in) To join our scientific poster session, please send a printable PDF file according to the following specifications: Document size of the PDF: 85 cm x 206 cm (33,4646 x 81,1024 in) portrait format Slug / Bleed: 2 mm (0,0787 in) Canvas size to work on: 85 cm x 120 cm (33,4646 x 47,2441 in) portrait format Slug / Bleed: 2 mm (0,0787 in) Images: 120dpi (low) - 150dpi (high) depending on size. All Images color Profile ISO Coated v2 (ECI) Deadline: 1 June cm (81,1024 in) 20 cm (7,87402 in) max. 15 cm (5,90551 in) All posters will be printed by PDA and displayed as part of the exhibition. Poster Display is included in the regular conference registration fee. Please send your file and poster title to Nadjeschda Gomez-Stahl gomez@pda.org.

10 FLOOR PLAN Grand Ballroom Berlin Exit POSTER SESSION Conference Room PDA MEDIA LIBRARY PDA Elevators Stairs En Atrium 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 10 pda.org/eu/annual2018

11 Exhibitor Table Top TSI 1 Terumo 2 Brevetti Angela 4 Altran 12 Datwyler 13 OMPI 14 Rommelag 15 Vanryx CRL 18 PQR 19 Veltek 20 SKAN Steriline 22 Wilco Rapid Microbio. Tech PTI 29 Novatec LIGHTHOUSE 31 trance 1 14 Table Top 2 m x 3 m (6 m 2 ) Catering Poster Session PDA Media Library PDA Registration pda.org/eu/annual

12 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

13 PDA Education Program June 2018 Practical Approach to Quality Culture Two-Day Training Course June 2018 Best Compliance Practice in a GMP Regulated Testing Laboratory Two-Day Training Course June 2018 Test-Methods for Pre-filled Syringe Systems Two-Day Training Course

14 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 Functions: Middle Management Managers with employee responsibility Group Leaders Department Heads Directors Executive Level Departments: Quality Assurance Quality Control Production Purchasing Regulatory Affairs R&D Human Resources Controlling Learning Objectives This training course is interactive, hands-on, and will empower you to measure, develop and improve the quality culture of your company: 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 Faculty Thomas Krieger, PhD, KU-Pharma Consulting Thomas Krieger is founder and CEO of Krieger Unternehmensberatung - Pharma (KU-Pharma) since KU-Pharma is providing quality consulting in quality assurance, in value-based Quality Culture and support as a Qualified Person for the pharmaceutical industry. After the Ph.D. in Pharmacy, Thomas graduated as specialized pharmacist of Pharmaceutical Analysis. For 25 years he holds the legal qualification and has professional experience as a Qualified Person pursuant to Directive 2001/83/EC. For 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, 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 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). 14 pda.org/euannual2018

15 TRAINING COURSE AGENDA Thursday, 28 June :00 17:45 9:00 Welcome & Introduction Friday, 29 June :00 16:30 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? 9:45 Lecture 2: Quality Behaviors What are quality behaviors? What are good quality behaviors? What are bad quality behaviors? How are they measured? 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? 10:00 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? 14:45 Coffee Break 15:15 Interactive Session 6: Exercise 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 16:15 Q&A 16:30 End of Training Course 17:45 End of Day 1 pda.org/eu/annual

16 TWO-DAY TRAINING COURSE Best Compliance Practice in a GMP Regulated Testing Laboratory Overview This course provides detailed understanding regarding the implementation of respective cgmp requirements in a state-ofthe-art quality control laboratory in a pharmaceutical company. The course does not just provide an overview about the most important cgmp regulations (OOS management, sample management, method validation, training, documentation, data management). In extensive workshops those regulations are further explained and extensively discussed within the group and solutions for the implementation are developed. Those results are further discussed with the trainers and with all attendees. This approach will not only provide the respective knowledge but also the ability to implement those solutions in the laboratory of the attendees. Who Should Attend The course should be attended by operators and supervisors in quality control laboratories of the pharmaceutical industry which are faced with the challenge to implement those, sometimes complex cgmp regulations into their daily business in an efficient and effective manner. Laboratory personal Head of quality control laboratories Supervisors Quality Assurance personal focusing on quality control topics, for example quality-on-the-floor personal Learning Objectives Understanding how the most important cgmp requirements can be implemented in the quality control laboratory Development of approaches regarding the implementation of cgmp compliance within the quality control laboratory considering German and international regulations Competence regarding the implementation of data integrity compliance in the quality control laboratory, for example audit trail review. Self-contained management of OOS-results Development of sampling protocols using statistical tools Implementation of training programs in quality control laboratories Faculty Dirk Feldmann, PhD, Head of Quality Operations, QP, Bausch & Lomb, Berlin Dirk Feldmann studied Pharmacy at the FU Berlin and finished his PhD thesis in Food Chemistry at the TU Berlin. In 1996 he became the laboratory head of several analytical laboratories of the German military forces in Berlin. Since 2006, he has held various positions at Bausch & Lomb, Berlin (Head of laboratory for bulk, finished goods and stability control and deputy head of QC, Head of Quality Assurance, Qualified Person, Head of Manufacturing). Currently Dirk Feldmann holds the position of Head of Quality Operations/Batch Release and QP at Bausch & Lomb, Berlin. Furthermore, between 2010 and 2012 he held the position of a pharmacist at Saint Luke Foundation / Kilimanjaro School of Pharmacy in Moshi, Tanzania as part of his work in an international development aid project. Klaus von Jan, PhD, CRS Compliance & Regulatory Services After his studies of chemistry at the TU Stuttgart and his PhD in Organic Chemistry about the synthesis and characterization of the structure of Oligonucleotides, Klaus von Jan joined Millipore BioSyntech GmbH, Hamburg, as Head of Quality Control and Quality Assurance in In 1995 he joined Chiron Vaccines Germany in Marburg as Director Quality Assurance Bulk Manufacturing Germany. Since 2006, Klaus von Jan is an independent consultant in the pharmaceutical industry focusing on aseptic manufacturing, vaccines and biologics, quality control, computer system validation, data management, FDA inspections and interims management. He has been the co-founder of Compliance Systems GmbH in 2006 as well as co-founder and co-owner of the Swiss-based pmc-support GmbH. 16 pda.org/euannual2018

17 TRAINING COURSE AGENDA Thursday, 28 June :00 17:00 9:00 Welcome & Introduction Friday, 29 June :00 16:30 09:00 Recap Day 1, Open Questions 9:45 cgmp-requirements in the Quality Control Laboratory - A Short Overview OOS-management, aborted tests Method Validation / Method Verification Sample Management Sampling Data Management Documentation Training 10:45 Coffee Break 11:15 Case Study 1 / Workshop: OOS-Management, Practical Example Case explanation Expectation of the teamwork Presentation of results Best Practice discussion 12:30 Lunch Break 13:30 The QP in the Quality Control Laboratory Typical issues / failures in the daily business Failure during sampling Development of sampling protocols Statistical tools for determination of sample size 15:00 Coffee Break 15:30 Case Study 2 / Workshop: Development of a sampling protocol and determination of the sample size based on the presented methods Presentation of results and Best Practice discussion 17:00 End of Day 1 9:30 Introduction to Data Management 21 CFR Part 11, Annex 11 Expectations of authorities (MHRA, FDA) Data integrity Batch related audit trail review Documentation and data security 10:45 Coffee Break 11:30 Case Study 3 / Workshop Management of an FDA 483 observation regarding data integrity Implementation and documentation of a batch related audit trail review Presentation of results and Best Practice discussion 12:30 Lunch Break 13:30 Case Study 4 / Workshop Method Validation / Method Specification Development of an activity protocol for the relocation of a sterility laboratory Presentation of results and Best Practice discussion 14:30 Coffee Break 15:00 Case Study 5 / Workshop: Development of a Training Program for a Quality Control Laboratory How can you organize a wide range of trainings in an efficient and effective manner Success controls Development of a training program 16:00 Summary, Open Questions, Feedback 16:30 End of Training Course pda.org/eu/annual

18 TWO-DAY TRAINING COURSE Test-Methods for Pre-filled Syringe Systems Overview The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a PFS from the idea to finished marketed product. Who Should Attend The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System Engineers and Managers in Device Development and all other technical functions surrounding syringe systems Quality Personal / Regulatory Personal Clinical and commercial Drug Product Manufacturing Learning Objectives Upon completion of the course the participants will have solid knowledge of Materials used for PFS Systems Luer Cone and Luer Lock Compliance Testing Requirements for the empty sterile sub-assembled syringe ready for filling Test Methods for Drug Product Filled Syringes PFS used in Delivery Systems Faculty Horst Koller, CEO, HK Packaging Consulting Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany. Roman Mathaes, PhD, Senior Group Leader, Lonza Drug Product Services Roman is leading the Lonza particle lab and the container closure integrity testing. In this role, he is responsible for container closure integrity testing of vials and Pre-filled syringes and process development of capping / crimping. Prior to this assignment, Roman was working within Roche / Genentech network supporting process development of the commercial manufacturing vial capping process. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King s College London. He holds a PhD in Pharmaceutical Technology from the University of Munich for work on subvisible particle characterization. 18 pda.org/euannual2018

19 TRAINING COURSE AGENDA Thursday, 28 June :00 17:45 9:00 Welcome 9:15 Introduction to Syringe Systems and Components Coffee Break 11:00 Regulatory Requirements of Finished Pre-filled Syringes Part 1 System Characterization / Physical Characterization 12:30 Lunch Break 13:30 Regulatory Requirements of Finished Pre-filled Syringes Part 2 Pharmaceutical Characterization 15:30 Coffee Break 16:00 Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes 17:30 Wrap-up of Day 1 Friday, 29 June :00 15:30 9:00 Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1 Cone Breakage / Flange Breakage / Leakage 10:15 Coffee Break 10:45 Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1 (cont.) Cone Breakage / Flange Breakage / Closure Testing 11:45 Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 2 Break Loose and Gliding Force / Needle Testing / Particulate Matter 13:15 Lunch Break 14:15 Additional Testing for Use in Delivery Devices 15:15 Wrap-up of Day 2 15:30 End of Training Course 17:45 End of Day 1 pda.org/eu/annual

20 INFORMATION VENUE Berlin Marriott Hotel Inge-Beisheim-Platz Berlin Germany Tel: Special Rates PDA Europe has reserved a limited number of rooms until the 12 May Book your group rate for PDA. Single Room 195 per room and night Double Room 215 per room and night including breakfast, VAT and Service charge. City tax applies. 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 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. BERLIN MARRIOTT HOTEL BERLIN 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 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 DEZJESE 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. 20 pda.org/eu/annual2018

21 PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: Pharmaceutical Microbiology Simulcast Conference October Berlin Germany October Bethesda USA Register by 26 August 2018 and SAVE! October 2018 Marriott Hotel Berlin Germany

22 3 rd PDA Europe Annual Meeting Reg Form Page June 2018 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 EARLY BIRD DISCOUNT Book by 29 April 2018 to receive 200* off the conference fee only 25 June Interest Group Meeting IG Meeting Fee Freeze Drying All Participants June Interest Group Meeting IG Meeting Fee Quality Systems All Participants June Conference only Conference Fee 3 rd PDA Europe Annual Meeting PDA Member 1695 Poster Presenter please mark here (written approval required, conference fee applies) **Nonmember 1995 * Early Bird 750 **Regulatory/Academic June Two-Day Training Course Training Course Fee Best Compliance Practices at the GMP Testing Laboratory All Participants June Two-Day Training Course Training Course Fee Practical Approach to Quality Culture All Participants June Two-Day Training Course Training Course Fee Test-Methods for Pre-filled Syringe Systems 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 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 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). 22 pda.org/eu/eannual2018

23 Reg Form Page 2 3 rd PDA Europe Annual Meeting This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 3 WAYS TO REGISTER ONLINE: pda.org/eu/annual2018 FAX: registration-europe@pda.org June 2018 Berlin Germany 1 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. 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. 2 3 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 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 29 April 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. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info-europe@pda.org or fax to 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/annual

24 P D A E U R O P E E V E N T S 13 April Interest Group Meeting Visual Inspection IG Berlin, Germany April Vaccines Málaga, Spain 8-9 May Virus Forum Florence, Italy 17 May Annex 1 Dublin, Ireland May Pharmacopoeia Conference Vienna, Austria 5-6 June Advanced Therapy Medicinal Products Amsterdam, The Netherlands 25 June 25 June June Interest Group Meeting Quality Systems Interest Group Meeting Freeze Drying 3 rd PDA Europe Annual Meeting IG IG Berlin, Germany October Pharmaceutical Microbiology Berlin, Germany October Visual Inspection Forum Berlin, Germany 6-7 November Outsourcing & Supply Chain - A 360 View Seville, Spain 22 November Project Management in the Pharmaceutical Industry Challenges & Possibilities Berlin, Germany November Pharmaceutical Freeze Drying Technology Seville, Spain November 11 th Workshop on Monoclonal Antibodies Seville, Spain Subject to change For latest info: europe.pda.org Shortlist 28 Mar 2018 Events with additional Education Program. More information General Information PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: Conference Information Melanie Decker Director Events & Exhibitions Tel: decker@pda.org Training Course Information Elke von Laufenberg Manager Training & Education Tel: laufenberg@pda.org