Webinar — Tips for Successful MAA Submissions in Europe

Securing marketing authorization in Europe requires a deep understanding of regulatory pathways, dossier structure, and evolving EMA expectations. In this interactive webinar, our regulatory experts walk through proven, regulator-ready strategies to strengthen your MAA submission—reducing clock-stops, validation defects, and approval delays.

This session provides actionable insights for navigating every stage of the submission process, from intelligent procedure selection and early scientific advice to airtight Module 3 documentation, benefit–risk narratives, and final labeling coordination.

Interested in learning more about how to conduct successful MAA submissions?

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Meet our Speakers

Frank de Vries

Vice President, Strategy, Regulatory Sciences – Development

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Paula van Hennik

Vice President, Clinical, Regulatory Sciences - Development

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Frank de Vries

Frank has over 30 years of experience in industry in a broad Regulatory Scientific field across all product types and multiple therapeutic areas including (pediatric) rare diseases and leads a team of subject matter experts in Regulatory Sciences to advise, support or lead overall regulatory strategy development and execution.

Frank’s broad and varied experience within the drug development industry includes significant interaction with the European Medicines Agency (EMA) and majority of national regulatory agencies across Europe, Middle East, CIS Region, Africa and to a certain extent LATAM, APAC, Canada, Australia, US. Regulatory interactions include but are not limited to scientific advice/protocol assistance, orphan applications and maintenance, pediatric investigation plans, early interactions, pre-submission meetings with EMA and/or Rapp/Co-Rapp and full marketing authorisation application pre-submission and full procedural support.

Frank has led various due diligence activities for product or portfolio acquisition and supported various Mergers & Acquisitions and served as international expert witness in arbitration court cases. Aside from Regulatory Scientific experience, Frank also held positions in Business Development, In/out-licensing, Commercial, Marketing & Sales, Quality and Pharmacovigilance.

Paula van Hennik

After finalising her PhD in Hematology in 2001 and spending almost 11 years conducting fundamental research on hematopoietic cell migration, Paula joined the Dutch Medicines Evaluation Board early 2012. Initially as clinical assessor, later as senior clinical assessor, with focus on products for oncology, hemato-oncology and hematology. From August 2016 up to February 2023 she was alternate CHMP (Committee for Medicinal Products for Human Use) member representing the Netherlands in this committee. In this committee, deciding on amongst others the benefit/risk of (extensions of) European marketing authorization applications, the oncology, haemato-oncology, part of the benign hematology, female reproductive and osteoporosis products were at the center of her portfolio. These included biologicals, small molecules and advanced (gene and cell) therapy products.

In early 2023 she has started to work at ProPharma, initially as Group Head Clinical and later as Vice President, Clinical, providing procedural support and expert advice to clients with human medical products in various stages of development with the focus on the EU regulatory system.