Gilles Chénard has over 20 years’ experience in vaccines R&D and Regulatory Affairs. In his position as Regulatory Filing Expert, he currently provides expertise on viral and microbial safety in support of regulatory filings for adenovirus-vectored vaccines at Janssen Vaccines & Prevention, Leiden, The Netherlands. His focus is on Module 3, section 3.2.A.2, Adventitious Agents Safety Evaluation, including presenting the overall safety control strategy in briefing books and drafting the underlying risk assessments. Having been closely involved in Janssen’s Covid-19 vaccine development and regulatory approval process, he has a good appreciation for the role prior knowledge can play in streamlining development and satisfying regulatory requirements without compromising viral safety. Prior to joining Janssen Vaccines and Prevention, he worked in Regulatory Affairs for veterinary vaccine manufacturers, obtaining marketing authorizations in the EU, USA, Canada and a limited number of Middle East and Asian countries. He holds a Master of Science in Biotechnology from the Wageningen University in The Netherlands.