Anabela Marcal

EMA Liaison Official to FDA
European Medicines Agency

Anabela Marcal is the EMA Liaison Official to FDA since July 2020. Previously Ms. Marçal had an active role in activities for the implementation of the new EU Clinical Trials Regulation, becoming Head of Clinical Trials in 2020. She was also Head of Committees and Inspections Department and was closely involved in international collaboration initiatives. Ms Marçal joined the EMA in 1999 where she held positions in pharmacovigilance, post authorisation regulatory procedures, compliance and GXP inspections, clinical trials and management of EMA’s Scientific Committees.

Presentation(s):

• Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network

  Wednesday, September 18, 2024
  9:15 AM – 10:30 AM PDT

• Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives

  Wednesday, September 18, 2024
  2:15 PM – 3:15 PM PDT

• Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products

  Thursday, September 19, 2024
  9:15 AM – 10:30 AM PDT

• Considerations for Global Harmonization and Accelerated Drug Development

  Thursday, September 19, 2024
  4:30 PM – 5:30 PM PDT