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Kevin Klein

Consultant Exon Consultancy

Kevin Klein (PhD) is a research fellow at Utrecht University and senior consultant at Exon Consultancy working in the field of pharmaceutical policy and regulation. He has a background in Bio-Pharmaceutical Sciences with a specialisation in Science Based Business from Leiden University and over 10 years’ experience in research and consulting.

Kevin obtained a PhD on regulation of complex medicines from the WHO Collaborating Centre for Pharmaceutical Policy and Regulation, of the division of Pharmacoepidemiology and Clinical Pharmacology of Utrecht University. During his work as a consultant he was involved in a number of projects on regulatory science topics around complex medicines, biologics, pharmacovigilance and new regulatory approaches to accelerate patients’ access to medicines.

See Kevin Klein at this event

  • Day 3 Thursday 5 December

Combining strengths: Preparing regulatory systems for combination products for advanced therapies and biologics

09:00 - 10:30 CET / 19:00 - 20:30 AEDT

Session objectives:

  • Raise awareness on the current global regulatory landscape on ATMPs and Drug-Devices combination products (DDCPs).
  • Share regulatory best practices and challenges in the APEC region.
  • Discuss the need for capacity-building activities on ATMPs and DDCPs.
  • Discuss the opportunity to develop for the APEC region a cooperative network of experts and an effective roadmap for a combined approach for ATMPs and DDCPs.