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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
Agencia Espanola De Medicamentos Y Productos Sanitarios, Spain
Head of Sector, Clinical Trials Division
Sandra Petraglia, MD, PhD
AIFA - Agenzia Italiana Del Farmaco, Italy
Head of Pre Authorisation Department
Lene Grejs Petersen
Danish Medicines Agency, Denmark
Senior EU CT policy adviser