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Session 2: Key Concerns Raised from Ongoing Implementation Activities
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
The session lays down the major concerns for Member States. It will discuss practical issues to deal with:
- data disclosure aspects
- development of lay summaries
- Part II requirements
- Annex VI.
Speaker(s)
Maria Antonia Serrano Castro, MD, PHD
Head of Sector, Clinical Trials Division, Agencia Espanola De Medicamentos Y Productos Sanitarios, Spain
Sandra Petraglia, MD, PHD
Head of Pre Authorisation Department, AIFA - Agenzia Italiana Del Farmaco, Italy
Lene Grejs Petersen
Senior EU CT policy adviser, Danish Medicines Agency, Denmark
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