InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine Moncad
Conditional marketing authorisation (CMA) can help bring innovative medicines to patients with high unmet medical needs sooner. But for sponsors, particularly emerging biotechs and first-time marketing authorisation holders, approval is only the beginning.
In this latest episode of the RegRapPod − InConversation series, Regulatory Rapporteur Managing Editor Claire McDermott speaks with Catherine Moncad, Vice President of Regulatory Services at TMC Pharma Services Ltd, about the realities of planning for, securing and maintaining a conditional marketing authorisation in the EU.
Catherine explains why a CMA should not be viewed as a faster or lighter version of a standard marketing authorisation. Instead, it represents the start of a structured programme of evidence generation, regulatory submissions and post-authorisation commitments.
The conversation explores:
- Why sponsors should begin planning for post-approval commitments as early as possible
- The operational challenges that can arise after a CMA is granted
- The importance of clear ownership, cross-functional governance and robust escalation pathways
- The reasons why smaller and resource-constrained organisations need to plan not only for approval, but for the years of activity that follow
- The ways in which experienced regulatory support can help sponsors establish the capabilities needed across regulatory, clinical, safety, quality, commercial and supply chain functions
Listen now to hear practical advice for organisations preparing for a conditional marketing authorisation and for those seeking to successfully manage the transition from conditional to standard marketing authorisation.
This podcast is also available on YouTube here.
SHOW NOTES:
If you would like to advertise on the RegRapPod InConversation, please contact our Commercial team at commercial@topra.org. For any other queries you can write to Claire McDermott, Managing Editor, at publications@topra.org
You can listen to this podcast on Apple Podcasts here.
