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Regulatory Science Forum


Session 4: Body of Evidence

Session Chair(s)

Anne  Morant, PhD, MSc

Anne Morant, PhD, MSc

  • Regulatory Science Specialist, freelance
  • Anne Morant Consulting, Denmark
Session Overview: The ‘Body of Evidence’ session will revolve around generation of substantial evidence of clinical efficacy to support approval of new medicines. With focus on EMA and FDA, the presenters will share results of their regulatory science research on topics such as approvals based on a single pivotal trial; demonstration of clinical relevance; as well as pre- and post-approval evidence pertaining to use of expedited pathways.

Speaker(s)

Petra  Sevcikova

Systematic analysis of evidence supporting expedited approvals by the EMA 2011-2018 and fulfilment of post-marketing obligations

Petra Sevcikova

  • Honorary Senior Researcher, Centre for Regulatory Science
  • Newcastle University, United Kingdom
Lourens  Bloem, PharmD, MSc

Clinical Value Of Oncology Medicines In Europe: Is It Different For Conditionally Approved Medicines?

Lourens Bloem, PharmD, MSc

  • PhD Candidate / Pharmacovigilance Assessor
  • Utrecht University / Dutch Medicines Evaluation Board, Netherlands
Katrine  Schultz-Knudsen, MSc

Providing Substantial Evidence with a single pivotal trial: Discussion of Regulatory trends in the EU and US

Katrine Schultz-Knudsen, MSc

  • Graduate
  • H. Lundbeck A/S, Denmark
João  Duarte, MPharm, MSc

Clinical relevance: an analysis of EMA and FDA Advisory Groups in support of new Marketing Authorisation applications between 2011 and 2015

João Duarte, MPharm, MSc

  • Director, Business Planning & Operations, Global Regulatory Affairs, R&D and Com
  • Alexion Pharmaceuticals, France

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