Regulatory shifts ahead: preparing for EU pharmaceutical reform and FDA changes

Regulatory change is underway on two fronts. FDA review practice has evolved meaningfully over recent review cycles, and the EU has finalised 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 offered an early look at what was changing and how to get ahead of it.

In this session, William Lian (BioDuro) covered 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 also introduced 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 unpacked 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.

Watch the session with BioDuro and DADA Consultancy to find out what’s changing and what sponsors should be preparing for.

What you’ll learn:

• Why FDA Clinical Holds happen and how CMC readiness can help prevent them
• How FDA’s evolving approach to NAMs could affect your preclinical testing plan
• How the EU’s pharmaceutical legislation reform affects Master File eligibility
• How to navigate the European ‘green legislation’
• How to position your pipeline ahead of these changes taking full effect

Watch on demand today!