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From Indication-Based Labels to a New Era of Evidence Generation – What Are the Future Roles of Regulators and HTA Bodies?
Session Chair(s)
Jordi Llinares Garcia, MS
Head of Research and Innovation
European Medicines Agency, Netherlands
Defining the indication has direct consequences for downstream actions. Regulator and HTA collaboration increases mutual understanding and facilitating availability to medicines while help developing new models for data generation and assessment.
Learning Objective : Discuss how collaboration between regulators and HTAs helps facilitating patient access to medicines by clarifying the process to define and evidence supporting an indication Present the rationale from the CHMP on wording of indications Discuss and identify areas for development in view of new evidence generation trends
Speaker(s)
Panelist
Edith Frénoy, MA, MSc
MSD Europe Inc., Belgium
Director, European Public Policy – Strategic EU Advocacy Lead
Regulatory considerations when wording indications
Kristina Dunder, MD, PhD
Medical Products Agency, Sweden
Clinical Assessor, Senior Expert, CHMP Member
Panelist
Regina Skavron, DrMed, MSc
Federal Joint Committee (G-BA), Germany
Scientific Officer, Pharmaceuticals Department
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