Webinar

Know Your Market: US and EU Regulatory Expectations for Combination Products

The increased prevalence of combination products requires a deeper understanding of what regulators expect in different markets and the kinds of studies required. Manufacturers will need to consider how to manage the different regulatory activities, such as usability testing and bridging studies, that are involved with drug and device development.

Watch the webinar

Through a series of panel discussions, we aim to provide valuable insights for regulatory professionals involved in the development and regulation of combination products, ultimately enhancing their understanding and approach to navigating the complex landscape of drug-device development.

Key learnings

  • Differences in regulation between the US and EU for combination products.
  • The impact of new regulatory guidance on the market space.
  • Considerations regarding usability studies and clinical trials.
  • The potential need for strategies to address bridging studies.
  • The co-existence of design control and drug development activities.

Speakers

Audrey Toulemonde

Associate Director at Cencora PharmaLex UK

Thomas Stover, Ph.D.

Principal Consultant, Development Consulting and Regulatory Affairs, US, Cencora PharmaLex.

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