PDA Europe Conference, Exhibition, Education
Vaccines The Parenteral Drug Association presents:
24-25 April 2018 Melia Hotel
Mรกlaga | Spain
LETTER FROM THE CHAIRS Dear Colleagues, SCIENTIFIC PL ANNING COMMIT TEE
• Cristiana Campa, Conference Chair, GSK Vaccines • Nancy Cauwenberghs, Conference Chair, Merck Sharp & Dohme • Martha Folmsbee, PALL • Thierry Gastineau, Sanofi Pasteur • Joachim Leube, Janssen Supply Chain • Annick Vandercammen, GSK Vaccines • Kerstin Wilken, PDA Europe • Sylvia Becker, PDA Europe, Manager Programs & Events
We are delighted to invite you to the 2018 PDA Europe Vaccines conference to be held 24-25 April 2018. The conference will address new trends in vaccine development and life cycle man agement, including (1) use of platform technologies, (2) prior knowledge, (3) dev elopment of novel vaccines comprising therapeutic vaccines and cancer vaccines, and (4) considerations on accelerated development scenarios. In this context Quality by Design principles have now been embedded in various aspects of vaccine development and beyond. The conference will provide an over view of the applicability of QbD in various aspects, from product, analytics and process standpoint and considerations during life cycle management, as well as touch base on newer trends in the regulatory field such as ICHQ12. We aim to continue the discussion around current CMC trends and regulatory stra tegies for emerging diseases, as started in frame of the Ebola vaccine some years ago and which has evolved since then.
We look forward to welcoming you to this special PDA Europe event in Spain!
Sincerely, the Chairs
Cristiana Campa, GSK Vaccines Conference Chair
Nancy Cauwenberghs, MSD Conference Chair
S C H E D U L E AT A G L A N C E 24 April
9:00 – 18:30
Vaccines
24 April
19:30
Networking Dinner
25 April
9:00 – 13:15
Vaccines
For latest information, please visit: pda.org/EU/Vaccines2018 2
pda.org/EU/Vaccines2018
Conference, Exhibition, Poster Session
Conference, Exhibition, Poster Session
WELCOME
TO MÁLAGA
pda.org/EU/Vaccines2018
3
CONFERENCE AGENDA 12 Apr 2018
Tuesday, 24 April 2018 9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD
Session 1: Regulatory Updates 9:10
Regulatory Convergence for Vaccines & Post Approval Changes
Heidi Meyer, Paul-Ehrlich-Institut
9:40
Harmonized Approaches for Vaccine Lifecycle Management
Richard H. Siggers, Health Canada
10:10
Ph. Eur. Hot Topics in the Field of Vaccines for Human Use
GwenaĂŤl CirĂŠfice, European Directorate for the Quality of Medicines & HealthCare, EDQM
10:40
Q&A, Discussion
11:15
Coffee Break, Poster Presentations & Exhibition
Session 2: Platform Technologies & New Products
Moderator: Kerstin Wilken, PDA Europe
11:45
A New TB Vaccine on the Horizon
Leander Grode, VPM
12:10
Next Generation of Glycan-based Vaccines
Arne v. Bonin, Vaxxilion
12:35
Use of Platform and Prior Knowledge to Advance Development of Adenoviral Vector-based Vaccines
Els van Deventer-Troost, Janssen J&J
13:00
Development and Optimization of Viral Platform Manufacturing Processes for Cost Effective and Faster Release of Vaccines
Anissa Boumlic, Merck KGaA
13:30
Lunch Break, Poster Presentations & Exhibition
Session 3: Accelerated Development and Prior Knowledge
4
Moderator: Thierry Gastineau, Sanofi
Moderator: Nancy Cauwenberghs, MSD
14:30
Prior Knowledge - Considerations for Vaccines
Mats Welin, MPA
15:00
Acceleration Strategies for Fast Access of Vaccines to Patients
Amin Khan, GSK Vaccines
15:30
A Vaccine for Ebola Virus - A Case Study on Approaches to Accelerate Joseph P. Califano, MSD Process Development and Characterization Studies
16:00
Q&A, Discussion
16:30
Coffee Break, Poster Presentations & Exhibition
pda.org/EU/Vaccines2018
CONFERENCE AGENDA
Session 4: Risk-based Approaches to Analytical Development and Facility Design for Vaccines
Moderator: Annick Vandercammen, GSK Vaccines
17:00
Application of the QbD Mindset to the Analytical Strategy The Key to Success
Thomas Jacques, GSK Vaccines
17:30
Challenges and Opportunities of QbD Integration in Vaccine Development and Manufacturing
Nausheen Rahman, Sanofi Pasteur
18:00
Risk-Based Biopharmaceutical Facility Design Approaches
Kavita Ramalingam Iyer, MSD
18:30
End of Conference Day 1
19:30
Networking Dinner
The Parenteral Drug Association is proud to invite you to a very special Networking Dinner. Join us for a fabulous evening in a traditional restaurant.
24 April 2018 19:00h Meeting Point: Hotel Lobby Joint Walking Tour 19:30h Dinner, Restorante „Casa Juan Los Mellizos“, Calle de San Ginés 20, 29620 Torremolinos, Málaga 22:00h Walking Tour back to Conference Hotel
pda.org/EU/Vaccines2018
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CONFERENCE AGENDA
Wednesday, 25 April 2018 9:00
Welcome
Kerstin Wilken, PDA Europe Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD
Session 5: Evolving Technical Challenges for Vaccine Manufacturing & Testing 9:05
Monocyte Activation Test: Predicting Pyrogenic Content without Animal Models
Sara Valentini, GSK
9:35
The Challenge of Process Parameters Categorization: A Comprehensive Ranking Process
Geoffroy Geldhof, GSK Vaccines
10:05
Process Validation and Continuous Process Verification of the Sterilization Process of Vaccines
Anton Mangold, tempris
Pre-fillable Syringe Selection Criteria for Vaccines: Technical Comparison of Several Syringe Types
Laurent Jeanmart, GSK Vaccines
10:35
11:05
Alexandre Cassis, GSK Canada
Christian Helbig, SCHOTT
Coffee Break, Poster Presentations & Exhibition
Session 6: Innovative Downstream Processing for Vaccines
Moderator: Martha Folmsbee, PALL
11:35
Case Studies and Successful Submissions: Sterile Filtration of Vaccines and Related Fluids
Erika Pfeiler, US FDA
12:05
Understanding the Sterile Filtration of Vaccine Nanosuspensions
Kalliopi Zourna, PALL
12:35
Filter-based Clarification of Viral Vaccines & Vectors
Youness Cherradi, Merck KGaA
13:00
Q&A, Discussion
13:15
Lunch Break, Poster Presentations & Exhibition
Session 7: Current Regulation & Industry Perspectives – Future Outlook
6
Moderator: Cristiana Campa, GSK Vaccines
Moderator: Nancy Cauwenberghs, Conference Chair, MSD
14:15
The Complexity of Post-Approval Change Management and New Regulatory Approaches: Relevance for Vaccine Products
Andrew Deavin, GSK Vaccines & Thierry Gastineau, Sanofi Pasteur
14:45
Vaccine Shortage - From Words to Action Vaccines Heads of Quality Perspective
Anders Vinther, Sanofi Pasteur & Marcello Colao, GSK Vaccines
15:15
Coffee Break, Poster Presentations & Exhibition
pda.org/EU/Vaccines2018
CONFERENCE AGENDA
15:45
Panel Discussion, Q & A Conference Highlights: Opportunities for Vaccine Development Panelists: Mats Welin, MPA Heidi Meyer, PEI Erika Pfeiler, US FDA Richard H. Siggers, Health Canada Gwenaël Ciréfice, EDQM
16:30
Summary & End of Conference & Farewell
Cristiana Campa, Conference Chair, GSK Vaccines Nancy Cauwenberghs, Conference Chair, MSD Kerstin Wilken, PDA Europe
2018 PDA Europe
Vaccines Committee and Speaker Biographies and many more....find them all online! https://goo.gl/mPZdCv
pda.org/EU/Vaccines2018
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PDA Europe Poster Session Streamlined Approach
Interactive and
Development of a Mass
Application of QbD to
Automated Statistical
to Product and Process
Educational Tools to
Spectrometry Platform
Method Development
Reports to Support QbD
Development Pathway
Support Quality-by-
for OMV Protein
in Analytical Method
to Enable Early Clinical
Design in Vaccines
Characterization
Development
Proof of Principle
Development
1
2
3
4
5
Walter Hoyer, GSK Vaccines
Massimiliano Biagini, GSK Vaccines
Gael de Lannoy, GSK Vaccines
Walter Hoyer, GSK Vaccines
Challenges for the
Analytical Quality by
Potency Evaluation for
Key Enablers for
Early Integration of
Registration of Vaccines
Design
New Vaccines:
Accelerating External
Sterility Assurance
In-vivo vs in-vitro
Tech Transfer of
Concepts into the
Model Suitability
Vaccine Drug Substance
Design of Manufacturing
Evolution to Support
Intermediate
Processes
Daniela Stranges, Giovanna Campanella, GSK Vaccines
Worldwide: CTD Alignment
CQA Definition
6
Mic McGoldrick, MSD
8
pda.org/EU/Vaccines2018
7
Gerard Scheppink, Janssen J&J
8
Claudia Magagnoli, GSK Vaccines
9
Peter Tsai, MSD
10
Giovanna Campanella, GSK Vaccines
Don’t miss the
3 PDA Europe Annual Meeting rd
Global Healthcare of the Present & the Future
Register by 29 April 2018 and SAVE!
26-27 June 2018
pda.org/EU/Annual2018
Berlin | Germany
Marriott Hotel
FLOOR PLAN Exhibitor Veltek
Poster Presenters Daniela Stranges, GSK Vaccines Giovanna Campanella, GSK Vaccines
Veltek
Walter Hoyer, GSK Vaccines
R STE
PO
POSTER SESSION
Massimiliano Biagini, GSK Vaccines Gael de Lannoy, GSK Vaccines Mic McGoldrick, MSD
N
SIO SES
Gerard Scheppink, Janssen J&J Claudia Magagnoli, GSK Vaccines Peter Tsai, MSD
Table Top 2 m x 3 m (6 m2) Catering Poster Session
TO E X H I B IT: PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.895 Euro net (table-top). For more information please contact gomez@pda.org 10
pda.org/EU/Vaccines2018
Over 1 billion containers annually are filled with vaccines for people around the world – made by SCHOTT. Join us at our talk on Wednesday, 25. April 2018, 10.35 am: Pre-fillable Syringe Selection Criteria for Vaccines Speech by: Laurent Jeanmart, GSK Vaccines, Christian Helbig, Head of Glass Syringes Wednesday, 25. April 2018, 10.35 am
SCHOTT AG, Pharmaceutical Systems, www.schott.com/pharmaceutical_systems
INFORMATION VENUE Melia COSTA DEL SOL Paseo Marítimo, 11 29620 Torremolinos Malaga | Spain Tel: (34) 952 38 66 77 Fax: (34) 952 38 64 17 https://goo.gl/Z2tnvg Special Rates Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. D I R EC T I O N S
MELIA COSTA DEL SOL MÁLAGA
GENER AL ADDRESS PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 436 55 08-0 Fax: +49 30 436 55 08-66 CO N F E R E N C E R EG I S T R AT I O N H O U R S Tuesday, 24 April: 7:00 – 17:30 Wednesday, 25 April: 7:00 – 12:00 T O E X H I B I T: 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. S PEC I A L R E QU I R E M E N T S If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration-europe@pda.org.
© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/PYp1oKWDfLA2
CO N TAC T I N FO R M AT I O N Conference Inquiries Melanie Decker Director Events & Exhibitions decker@pda.org Conference Program Inquiries Sylvia Becker programs-europe@pda.org Registration Customer Care Tel: +49 30 436 55 08-10 registration-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 www.lh.com/event-flight-booking and enter the access code DEZJEPH in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available. NOTE: Pop-ups must be enabled otherwise the booking platform window will not open. These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the access code as a reference.
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pda.org/EU/Vaccines2018
Vaccines
For contact at PDA Europe registration-europe@pda.org
24-25 April 2018 Málaga | Spain
3 WAYS TO REGISTER
1
1 ONLINE: pda.org/EU/Vaccines2018 2 FAX: +49 30 4365508-66 3 EMAIL: registration-europe@pda.org
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EARLY BIRD DISCOUNT
By Credit Card
Book by 4 March 2018 to receive € 200* off the conference fee only
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All fees given in Euro and excluding VAT (21 %)
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PDA Europe VAT I.D.: DE254459362 **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.
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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. 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). This special rate does not include one-year PDA membership.
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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 24 March 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 registration-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.
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2 0 1 8
P D A
E U R O P E
E V E N T S IG Berlin, Germany
13 April
Interest Group Meeting Visual Inspection
24-25 April
Vaccines
Málaga, Spain
8-9 May
Virus Forum
Florence, Italy
17 May
Annex 1
Dublin, Ireland
29-30 May
Pharmacopoeia Conference
Vienna, Austria
5-6 June
Advanced Therapy Medicinal Products
Amsterdam, The Netherlands
25 June 25 June 26-27 June
Interest Group Meeting Quality Systems Interest Group Meeting Freeze Drying 3rd PDA Europe Annual Meeting
15-16 October
Pharmaceutical Microbiology
Berlin, Germany
23-24 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
27-28 November
Pharmaceutical Freeze Drying Technology
Seville, Spain
27-28 November
11th Workshop on Monoclonal Antibodies
Seville, Spain
Subject to change
For latest info: europe.pda.org
Shortlist 12 Apr 2018
IG IG Berlin, Germany
Events with additional Education Program. More information – http://t1p.de/7p9z
General Information PDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66
Conference Information Melanie Decker Director Events & Exhibitions Tel: + 49 30 4365508-19 decker@pda.org
Training Course Information Elke von Laufenberg Manager Training & Education Tel: + 49 30 4365508-21 laufenberg@pda.org www.europe.pda.org