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Session 4: Body of Evidence
Session Chair(s)
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)
Systematic analysis of evidence supporting expedited approvals by the EMA 2011-2018 and fulfilment of post-marketing obligations
Petra Sevcikova
Newcastle University, United Kingdom
Honorary Senior Researcher, Centre for Regulatory Science
Clinical Value Of Oncology Medicines In Europe: Is It Different For Conditionally Approved Medicines?
Lourens Bloem, PharmD, PhD, MSc
Utrecht University, Netherlands
Assistant Professor Clinical Therapeutics
Providing Substantial Evidence with a single pivotal trial: Discussion of Regulatory trends in the EU and US
Katrine Schultz-Knudsen, MSc
H. Lundbeck A/S, Denmark
Graduate
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
Alexion, Astrazeneca Rare Disease, France
Senior Director,Business Planning and Operations, Regulatory and Quality Affairs
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