Marta Antunes | Director, EU EMEA CMC Regulatory Affairs
MSD

Marta Antunes, Director, EU EMEA CMC Regulatory Affairs, MSD

Marta is a Regulatory Affairs CMC Director, at Merck Sharp & Dohme based in London. She has demonstrated experience in Regulatory Affairs and Quality Assurance areas in global pharmaceutical companies. She is specialized in pre and post-approval CMC regulatory strategies in EU and EMEA markets for Small Molecules, Biologics and Vaccines. Marta has led multiple engagements with European and National Agencies optimizing submissions strategies and reducing the regulatory burden in EU/EMEA region. She has experience in leading transformative strategic initiatives and managing cross-functional teams. She holds a master’s degree in Pharmaceutical Sciences from University of Lisbon, Portugal and a MBA from Imperial College London, United Kingdom.

Appearances:



Day 3 - Thursday 31st October @ 12:30

Reliance Opportunities for Vaccines: Sharing Practices including AMA Pilot Experience

In this session, we will explore opportunities of reliance for vaccines supporting regulatory authorities’ decision-making based on information submitted and approved by high surveillance agencies. The collaboration among regulators reduces duplication of efforts at agency and industry level accelerating patients access to medicines, particularly, vaccines. Practices on post-approval and pre-approval space will be shared with focus on a recent pilot with the African Medicines Agency (AMA), which aims to establish a harmonized regulatory framework for medicines in Africa.

last published: 03/Oct/24 13:35 GMT

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