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Regulatory Science Forum
Session 4: Body of Evidence
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.
Systematic analysis of evidence supporting expedited approvals by the EMA 2011-2018 and fulfilment of post-marketing obligations
- Honorary Senior Researcher, Centre for Regulatory Science
- Newcastle University, United Kingdom
Clinical Value Of Oncology Medicines In Europe: Is It Different For Conditionally Approved Medicines?
Lourens Bloem, PharmD, PhD, MSc
- Assistant Professor Clinical Therapeutics
- Utrecht University, Netherlands
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
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
- Senior Director,Business Planning and Operations, Regulatory and Quality Affairs
- Alexion, Astrazeneca Rare Disease, France