#33: European Regulatory Meetings: How Best to Prepare and Perform

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Instructors

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  Steffen Thirstrup, MD, PhD

  • Director, NDA Regulatory Advisory Board
  • NDA Advisory Services Ltd, United Kingdom

  Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency (DKMA) acting as the Danish member of CHMP and additionally CAT at the European Medicines Agency.Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing Division. In March 2013 Prof Thirstrup joined NDA Group where currently is the director of Regulatory Advisory Board at NDA Regulatory Services Ltd.

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  Lisa Peluso

  • Principal Consultant, Strategic Communications
  • PharmApprove, a Member of the NDA Group, United States

  Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped 45+ teams prepare to present and defend their positions at FDA Advisory Committee meetings and EMA Oral Explanations. Lisa also creates and leads dynamic workshops to empower teams to communicate complex science with clarity.