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Regulatory Science Forum


Session 9: Labelling

Session Chair(s)

Anne  Morant, PhD, MSc

Anne Morant, PhD, MSc

  • Regulatory Science Specialist, freelance
  • Anne Morant Consulting, Denmark
The ‘Labelling’ session will include presentations of regulatory science research focusing on how clinical evidence of efficacy and safety translates into label claims for communication to health care providers and patients. Three different angles will be covered: Patient Experience Data, Real-World Evidence, and post-approval label changes related to safety. A brief panel discussion will to provide the opportunity for discussion and Q&As.

Speaker(s)

Fatima  Tarrahi

Introduction of safety-related changes to the drug label following large post-marketing cardiovascular outcome trials

Fatima Tarrahi

  • Masterstudent intern
  • CBG-MEB (Medicines Evaluation Board), Netherlands
Maren Ulrike  Koban

Reflection of Real-World Evidence in the product information

Maren Ulrike Koban

  • Director, Global Regulatory and Scientific Policy
  • Merck Healthcare KGaA, Germany
Anders Blaedel Lassen, LLM, MA, MSc

FDA’s Patient-Focused Drug Development Initiative: Does Patient Experience Data Translate into Drug Label Claims?

Anders Blaedel Lassen, LLM, MA, MSc

  • Head of Regulatory Science & Advocacy
  • Lundbeck, Denmark

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