If you are 2 years away from filing marketing applications (whether a small molecule, biologic, cell or gene therapy) and plan a marketing authorisation application to the EMA or MHRA...
Here’s what you need to know.
- What comes under the mandatory scope of the centralised procedure,
- The regulatory deliverables you must complete in the lead-up to filing your MAA,
- The timelines for the MAA evaluation,
- Everything that goes into the region-specific Module 1 of the MAA dossier,
- How does the rest of your dossier fit into Module 1, and
- Pharmacovigilance requirements, particularly the risk management plan.
We explain all of these considerations in our latest webinar in collaboration with Essjay Solutions, where we give an overview of…
‘The Secrets of the EU Marketing Authorization Application: A Comprehensive Guide to Timelines and Requirements’.
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