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Parenteral Drug Association Connecting People, Science and Regulation ®

Vaccines

Apr 24 - Apr 25, 2018 |
Apr 25, 2018 |
Meliá Costa del Sol | Malaga, Spain
  • Conference
  • Europe
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Speaker Biographies

Dear Colleagues,

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 management, including (1) use of platform technologies, (2) prior knowledge, (3) development 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 overview 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 strategies 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 next April!

Sincerely, The Chairs

Cristiana Campa, Conference Chair, GSK Vaccines
Nancy Cauwenberghs, Conference Chair, MSD

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Tuesday, 24 April 2018

9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe
Cristiana Campa, Conference Chair, GSK Vaccines
Nancy Cauwenberghs,Conference Chair, MSD

9:10 - 11:15
Session 1: Regulatory Updates
Moderator: Thierry Gastineau, Sanofi

9:10
Regulatory Convergence for Vaccines & Post Approval Changes
Heidi Meyer, Paul-Ehrlich-Institut

09:40
Harmonized Approaches for Vaccine Lifecycle Management
Richard H. Siggers, Biologics and Genetic Therapies Directorate, Health Canada

10:10
Human Vaccines in the European Pharmacopoeia: Latest Developments
Gwenaël Ciréfice, European Directorate for the Quality of Medicines & HealthCare, EDQM

10:40
Q&A, Discussion

11:15 – 11:45
Coffee Break, Poster Session & Exhibition

11:45 - 13:30
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 – 14:30
Lunch Break, Poster Session & Exhibition

14:30 – 16:30
Session 3: Accelerated Development and Prior Knowledge
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 Process Development and Characterization Studies
Joseph P. Califano, MSD

16:00
Q&A, Discussion

16:30 – 17:00
Coffee Break, Poster Session & Exhibition

17:00 – 18:30
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 Reception

Wednesday, 25 April 2018

9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe
Cristiana Campa, Conference Chair, GSK Vaccines
Nancy Cauwenberghs,Conference Chair, MSD

9:05 - 11:05 
Session 5: Evolving Technical Considerations for Vaccine Manufacturing
Moderator: Cristiana Campa, GSK Vaccines

9:05
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
Alexandre Cassis, GSK Canada

10:35
Pre-fillable Syringe Selection Criteria for Vaccines: Technical Comparison of Several Syringe Types
Laurent Jeanmart, GSK Vaccines
Christian Helbig, SCHOTT

11:05 – 11:35
Coffee Break, Poster Session & Exhibition

11:35 – 13:15
Session 6: Innovative Downstream Processing for Vaccines
Moderator: Martha Folmsbee, PALL

11:40
Filtering Confusion from the Review Process: Current Topics in Sterilizing Filtration at FDA/CDER
Erika Pfeiler, US FDA

12:05
Understanding the Sterile Filtration of Vaccine Nanosuspensions
John Welsh, PALL

12:35
Filter-based Clarification of Viral Vaccines & Vectors
Youness Cherradi, Merck KGaA

13:00
Q&A, Discussion

13:15 – 14:15
Lunch Break, Poster Session & Exhibition

14:15 – 17:00
Session 7: Global Industry Perspectives on Current Regulation - Future Outlook
Moderator: Nancy Cauwenberghs, 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 – 15:45
Coffee Break, Poster Session & Exhibition

15:45
Panel Discussion, Q & A - Conference Highlights: Opportunities for Vaccine Development
Mats Welin, MPA
Heidi Meyer, PEI
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

3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • 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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 4 March 2018
1.395 Euro

After 4 March 2018
1.595 Euro

Nonmember

By 4 March 2018
1.695 Euro

After 4 March 2018
1.895 Euro

Govern./Health Authority/Academic

By 4 March 2018
700 Euro

After 4 March 2018
800 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

Melia COSTA DEL SOL
Paseo Marítimo, 11
29620 Torremolinos
Malaga
Spain
Tel: (34)952386677
Fax: (34)952386417
Hotel Website

Located in Malaga, in the resort of Torremolinos, in the heart of the Costa del Sol, and strategically located right on the beach, Meliá Costa del Sol is the best option for unwinding, having fun and working in Malaga, thanks to its excellent location, its complete and comfortable facilities and its superb service

Modern rooms are bright and spacious. They have a terrace overlooking the Mediterranean Sea. All are air conditioned and have a safe, flat-screen satellite TV and well-equipped bathroom. Meliá Costa del Sol offers a buffet and continental breakfast, as well as Mediterranean cuisine for dinner. À la carte options are also available, and there is live music in Bar Barlovento.

PDA Europe has reserved only a limited number of rooms, please make sure to book your room for the PDA Group Rate

Single Room € 99 per night*
Double Room upon request*

*Rates are per room and night, including the following services and benefits:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI) 
  • 10% VAT, Taxes and Service Charge will apply

How to Get There

Malaga Airport – AGP
Airport Phone: +34 902 40 47 04
Hotel direction: 8,1km

Parking

  • Private parking: (reservation is needed)
  • 20 Euros per day

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4059
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