TOPRA IN Benelux CMC Aspects of Vaccines: Seasonal Influenza

TOPRA IN Benelux CMC Aspects of Vaccines: Seasonal Influenza
The TOPRA IN Benelux Steering Group is pleased to present this webinar about the Chemistry, Manufacturing and Controls (CMC) aspects of vaccines. As we are rapidly approaching the end of the year again, the time has come for many of us to receive another influenza vaccine. We will also devote some attention to the history of vaccines, the manufacturing process and the regulatory aspects of a flu vaccine.



Date: 09/12/2025
Time: 13:00 - 14:00 GMT / 13:00 - 14:00 CET

Duration: 1 hour
   
Suitable for
TOPRA members and non-members and other healthcare regulatory professionals.

Benefits for participants:
      - Learn about the history of influenza vaccines, their manufacturing process and regulatory aspects.
     


The main webinar presentation will run for approximately 30-40 minutes, which will then be followed by a Q&A session.  


Moderator


Ralph Hermanns, CMC/RA consultant at ReAl CMC Consulting B.V.
Ralph is a CMC expert with 25+ years of experience in drug product development, regulatory affairs, and analytical development. He has an extensive track record in lifecycle management, technology transfers, regulatory compliance gap assessments, and successful CMC dossier submissions leading to multiple EU approvals. He is skilled in implementing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, optimising development and validation strategies, and driving cross-functional collaboration to ensure regulatory and quality excellence.

Speakers


Stefano Di Giacomo, Regulatory and Quality Consultant at Capgemini Engineering
Stefano has an MSc in Biotechnology and is a regulatory affairs and quality consultant. After building solid R&D expertise through 10 years of experience working in different laboratories in Italy and Belgium, Stefano has transitioned into global CMC Regulatory Affairs in the past four years. Stefano successfully managed the CMC regulatory lifecycle for several established vaccines across global markets, and his work included developing submission strategies and efficiently handling numerous variations, commitments, scientific advice and Health Authority Questions from worldwide regulatory agencies.



Bruno Speder, Regulatory Affairs Lead at AstriVax, Leuven, Belgium
Bruno is a bioengineer by training and has almost 20 years of experience in supporting global regulatory development programs at various stages of development and leading discussions with the U.S. Food and Drug Administration (FDA) , the European Medicines Agency (EMA) and other regulators. He has supported a multitude of vaccine developments across a wide range of therapeutic areas, ranging from Respiratory syncytial virus (RSV) and influenza to malaria and dengue.

PRICING

TOPRA Members: Free 
Non-member: £60





 
When
09/12/2025 13:00 - 14:00
Where
ONLINE
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