By all accounts regulatory activities conducted during the period after the authorization of a medicine often burden the resources of regulators and the industry. Therefore, opportunities exist to make post-approval activities more efficient. From ways to streamline labelling changes to addressing changes in manufacturing processes and clinical indications, applying risk-based approaches to these activities are showing the potential to optimize the efficiency of these activities. Among these approaches is the use of regulatory reliance. In this webinar we will deep-dive into both the philosophy of optimizing post-approval lifecycle management along with updates on projects that are showing great promise in this arena. Join us for another interesting and lively discussion in the FRPanorama webinar series.
The agenda is as follows:
Topic 1: Why We Need to Optimize the Way We Manage the Oost-Approval Lifecycle of Medicines- Samvel Azatyan, Glonal Regulatory Expert
Topic 2: Innovative Approaches to Streamlining Post-Approval Regulatory Activities - Cammilla Horta Gomes, Latin America Regulatory Policy Lead, Roche
Topic 3: Reliance and Post-Approval Changes: An Agency Experience - Tryphone Octavian Gujema, Tanzania Medicines and Medical Devices Authority (TMDA)
The webinar is schedule for 9:00am to 10:15am Eastern Time on Wednesday, October 29th, 2025.
Want more information? Contact us at frpath@erudee.org
Follow the FRPath Project on LinkedIn HERE
