Regulatory Shifts Ahead: Preparing for FDA Changes and EU Pharmaceutical Reform

Regulatory change is underway on two fronts. FDA review practice has evolved meaningfully over recent review cycles, and the EU has finalized a sweeping reform of its pharmaceutical legislation that has not yet entered into force. For sponsors filing an IND with the FDA, preparing an EMA submission, or planning a Phase II expansion into the EU, this session offers an early look at what’s changing and how to get ahead of it.

In this session, William Lian (BioDuro) covers the current FDA IND landscape: where IND submission changes, how Clinical Holds get resolved, and why getting CMC right early is the key to avoiding them. William will also introduce FDA’s evolving expectations for nonclinical development, including initiatives such as the increased use of New Approach Methodologies (NAMs).

Miranda van Bodegom (DADA Consultancy) turns to the EU, where the change is legal, not procedural. She unpacks several developments under what EMA itself has called “the most significant overhaul of the regulatory framework in over two decades”. Miranda will introduce upcoming changes covering development and registration phases, pharmacovigilance and regulatory aspects, the new approach to environmental risk, and the expanded the use of Master Files.

Join BioDuro and DADA Consultancy to find out what’s changing, and what sponsors should be preparing for.

What you will learn:

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Speakers:

Miranda van Bodegom

Senior Consultant Regulatory Affairs

DADA Consultancy

William Lian

Director of Filing and Regulatory Affairs Office

BioDuro