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Regulatory Science Forum
Session 9: Labelling
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.
Introduction of safety-related changes to the drug label following large post-marketing cardiovascular outcome trials
- Masterstudent intern
- CBG-MEB (Medicines Evaluation Board), Netherlands
Reflection of Real-World Evidence in the product information
Maren Ulrike Koban
- Director, Global Regulatory and Scientific Policy
- Merck Healthcare KGaA, Germany
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