Vaccines

24 Apr - 25 Apr 2018
Malaga, Spain

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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

Program Highlights

Regulatory Speakers Confirmed!

  • Mats Welin
    Medical Products Agency, Sweden
  • Heidi Meyer, PhD
    Paul-Ehrlich-Institut
  • Gwenaël Ciréfice, PhD
    European Directorate for the Quality of Medicines & HealthCare, EDQM
  • Richard H. Siggers, PhD
    Biologics and Genetic Therapies Directorate, Health Canada
  • Erika Pfeiler, PhD
    CDER Division of Microbiology Assessment, US FDA

Agenda

Discover What's Happening Each Day
Day 1 24 Apr
Tuesday, 24 April

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

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Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Meliá Costa del Sol

Paseo Marítimo 11
Malaga, Spain Spain
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

Registration

Pricing Options

More information coming soon.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

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

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Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
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training-europe@pda.org
Registration Customer Care