Pharmacopoeia 2019 PDA EUROPE. The 2 nd Annual PDA Conference on International Developments in the Pharmacopoeial Landscape PEOPLE SCIENCE AND

Transcription

1 pda.org/eu/pharma PDA EUROPE Pharmacopoeia The 2 nd Annual PDA Conference on International Developments in the Pharmacopoeial Landscape CONNECTING PEOPLE SCIENCE AND REGULATION MAY 2019 GENEVA, SWITZERLAND EXHIBITION: MAY 2019

2 LETTER FROM THE CHAIRS Dear Colleagues, At the 2018 inaugural conference, representatives from globally recognized pharmacopoeias shared their authorities' and organisations approaches to international convergence, harmo nization & the future direction of pharmacopoeias with respect to the overall framework of regulations and guidelines. This resulted in valuable discussion and exchange and generated momentum we now intend to use and continue our efforts to delve deeper into issues relevant to manufacturers of active pharmaceutical ingredients, excipients and medicinal products. SCIENTIFIC PROGRAM PLANNING COMMITTEE Susanne Keitel, Chair, EDQM Nadine Ritter, Co-Chair, Global Biotech Experts Vinny Browning III, Amgen Graham Cook, Pfizer Once again, we kindly invite you to contribute your professional insights, views and best-practices in the effective and efficient implementation of international pharmacopoeial requirements. See you in Geneva! Frithjof Holtz, Merck KGaA Ruth Miller, PDA Janeen Skutnik-Wilkinson, Biogen Paolo Tozzi, Novartis Falk Klar, PDA Europe Sylvia Becker, PDA Europe, Senior Manager Programs & Events Susanne Keitel, PhD, EDQM, Chair Nadine Ritter, PhD, Global Biotech Experts, Co-Chair 2 pda.org/eu/pharma2019

3 WELCOME TO GENEVA SCHEDULE AT A GLANCE 16 May 9:00 18:00 Pharmacopoeia Conference, Exhibition 16 May 18:30 21:30 Networking Reception 17 May 9:00 16:30 Pharmacopoeia Conference, Exhibition For latest information, please visit: pda.org/eu/pharma2019 pda.org/eu/pharma2019 3

4 CONFERENCE AGENDA Thursday, 16 May Apr :00 Welcome and Introduction Falk Klar, PhD, PDA Europe Susanne Keitel, PhD, EDQM, Conference Chair Nadine Ritter, PhD, Global Biotech Experts, Conference Co-Chair Session 1: Working Principles of Pharmacopoeias in Their Regulatory Framework In this opening session, invited international representatives will share specifics with respect to Legal Status Governing Bodies Decision-making Methods & Tech Transfer: Minimum Requirements from a Pharmacopoeial Perspective Acceptance of Alternative Methods / Definition of Alternative Methods European Directorate for the Quality of Medicines and HealthCare, EDQM United States Pharmacopoeia, USP Pharmaceuticals and Medical Devices Agency, PMDA, Japan 10:30 Coffee Break, Poster Session & Exhibition ANVISA, Brazil Indian Pharmacopoeia Commission, IPC World Health Organization, WHO 13:00 Lunch Break, Poster Session & Exhibition Session 2: Introduction to Breakout Session This session will set the stage for the afternoon roundtable discussions by providing overviews, summaries and current key issues of each of the three main featured topics. 14:00 Analytical QbD and the Pharmacopoeia British Pharmacopoeia / MHRA Evolution of the Compendial Landscape Product Specific Monographs for Biotherapeutics Continuous Manufacture of Drug Products and Drug Substances EDQM & Janssen J&J GSK & Pfizer on behalf of EFPIA 15:30 Coffee Break, Poster Session & Exhibition 16:00 Breakout & Roundtables ANALYTICS BIOTHERAPEUTICS MANUFACTURING Interchangeability and Validation of Analytical Methods, Acceptance Criteria, QbD, etc. ATMPs, Monoclonal Antibodies, Biosimilars / Biobetters, etc. Continuous Manufacturing, PAT, Control of Impurities, etc. 17:00 Summary and Closing of Day 1 18:30 Networking Reception in Geneva 4 pda.org/eu/pharma2019

5 CONFERENCE AGENDA Friday, 17 May 2019 PARALLEL TRACKS Session 3 TRACK A TRACK B REFERENCE STANDARDS MANUFACTURE AND CHARACTERIZATION 9:00 Use of Compendial Reference Standards for Instrument Qualification and Method Validation EDQM Latest Developments in USP Biologics Performance Standards USP PRACTICAL EXAMPLES OF MONITORING, ASSESSMENT AND IMPLEMENTATION OF PHARMACOPOEIAL CHANGES Case Study: A Process for Monitoring and Engaging with Pharmacopoeias Biogen Compendial Compliance in a Global Environment & Global Process of Compendial Review Global Pharmacopoeia Solutions 10:00 Coffee Break, Poster Session & Exhibition Bioassay International Standards for Monoclonal Antibodies: New Reagents for New Challenges NIBSC Compendial Equivalence of In-house Reference Standards - Learnings and Key Challenges of the Process Novartis Control Strategy for Particulate Matter in Biopharmaceutical Drug Products - an Industry Perspective Hoffmann La Roche Challenges and Potential Risk of Not Having Harmonized Pharmacopeia Requirement: A Case Study Novo Nordisk 11:30 Q&A, Discussion 12:00 Lunch Break, Poster Session & Exhibition Session 4: Process for Prioritization in Convergence of Monographs and Maintenance of Convergent Status 13:00 Update on Recent PDG Developments and the New Maintenance Procedure on the ICH Q4B Annexes Adopted by the ICH Assembly Bilateral Working Principles: Pharmacopoeial Harmonization An Effective Process for Monitoring, Assessing, and Implementing Compendial Changes at a Global Pharmaceutical Company EDQM Novartis on behalf of EFPIA Eli Lilly Q&A, Closing Panel Discussion 15:00 Coffee Break, Poster Session & Exhibition Closing Keynote Joint Reflection from Pharmacopoeia & Industry EDQM & Pfizer 16:30 Summary & End of Conference Draft Program, all details subject to change without prior notice. pda.org/eu/pharma2019 5

6 FLOOR PLAN CONFERENCE 5 6 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 decker@pda.org 6 pda.org/eu/pharma2019

7 pda.org/eu/annual th PDA Europe Annual Meeting Global Healthcare of the Present and the Future JUNE 2019 AMSTERDAM, THE NETHERLANDS EXHIBITION: JUNE REGISTER BEFORE 28 APRIL AND SAVE UP TO 200!

8 INFORMATION VENUE Crowne Plaza Geneva Avenue Louis Casai Geneva Switzerland Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. DIRECTIONS TO E XHIBIT: 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/Exhibition/Sponsorship 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 GENERAL ADDRESS PDA Europe ggmbh Am Borsigturm Berlin, Germany Tel: Fax: CONFERENCE REGISTRATION HOURS Thursday, 16 May: 8:30 18:00 Friday, 17 May: 8:30 15:00 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 DEZQWLO 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. PDA Europe Supports the Children's Hospice Sonnenhof BUY A PACKAGE OF CHEWING GUMS AT THE REGISTRATION DESK. THANK YOU! To know more about the Sonnenhof Hospice, please visit 8 pda.org/eu/eventname2019

9 Pharmacopoeia Conference May 2019 Geneva Switzerland For contact at PDA Europe 3 WAYS TO REGISTER online: pda.org/eu/pharma2019 FAX: registration-europe@pda.org This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 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 subscription 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.) Information about Visa Matters 2 Registration 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 All fees given in Euro and excluding VAT (7,7%) Conference (16-17 May) PDA Member 1695 Nonmember 1995 Govern./Health Authority/Academic Early Bird Poster Presenter please mark here (written approval required, conference fee applies) 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 Conference Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies). 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) 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 3 colleagues for the conference at the same time and receive the 4 th registration free. For more information on group discounts please contact us at registration-europe@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 1195 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 31 March 2019 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 pda.org/eu/pharma2019 9

10 PDA EUROPE EVENTS 2019 europe.pda.org May Pharmacopoeia Geneva, Switzerland May 24 May Visual Inspection Week Interest Group Meeting Visual Inspection Berlin, Germany 4-5 June Advanced Therapy Medicinal Products Vilnius, Lithuania 24 June 24 June June Workshop: The Digital Robot Pharma Fab Interest Group Meeting Quality Systems 4 th PDA Europe Annual Meeting Amsterdam, The Netherlands 2 September 2 September 3-4 September Interest Group Meeting Freeze Drying Interest Group Meeting Technology Transfer BioManufacturing Munich, Germany 5 September Project Management in the Pharmaceutical Industry Munich, Germany September Pharmaceutical Freeze Drying Technology Berlin, Germany September Particles in Injectables Berlin, Germany 21 October 21 October 21 October October Workshops: Impact of Pre-filled Syringe Components on Biopharmaceuticals Innovating the Journey from Manufacturing to the Patient Innovative Drug Delivery Systems/Combination Products The Universe of Pre-filled Syringes and Injection Devices Gothenburg, Sweden November Pharma Logistics & Outsourced Operations Lisbon, Portugal Subject to change For latest info: europe.pda.org Shortlist 4 Apr 2019 CONNECTING PEOPLE SCIENCE AND REGULATION GENERAL INFORMATION PDA EUROPE GGMBH AM BORSIGTURM BERLIN, GERMANY TEL: FAX: INFO-EUROPE@PDA.ORG