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
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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
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11:15 – 11:45
Coffee Break, Poster Session & Exhibition
11:45 - 13:30
Session 2: Platform Technologies & New Products
Moderator: Kerstin Wilken, PDA Europe
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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
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13:30 – 14:30
Lunch Break, Poster Session & Exhibition
14:30 – 16:30
Session 3: Accelerated Development and Prior Knowledge
Moderator: Nancy Cauwenberghs, MSD
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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
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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
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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
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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
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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
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11:05 – 11:35
Coffee Break, Poster Session & Exhibition
11:35 – 13:15
Session 6: Innovative Downstream Processing for Vaccines
Moderator: Martha Folmsbee, PALL
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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
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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
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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
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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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