UPCOMING WEBINAR
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.