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Virtual Event

Sep 28, 2020 2:00 PM - Sep 30, 2020 6:00 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

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

CBG-MEB (Medicines Evaluation Board), Netherlands

Masterstudent intern

Maren Ulrike Koban, PhD

Reflection of Real-World Evidence in the product information

Maren Ulrike Koban, PhD

Merck Healthcare KGaA, Germany

Director, Global Regulatory and Scientific Policy

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

Lundbeck, Denmark

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