Mastering Regulatory and Development Strategies for Generics
Module 1 is Free to Attend – Register Below
Learn more about the course (dates, price, skills gained, and when module 1 is) by visiting the course page.
Module 1 Overview | Understanding the Regulatory Landscape for Generic Medicines
Live and Recorded | 60 Minutes
Understanding the Regulatory Landscape for Generic Medicines
- Understand what defines a generic medicine under EU and US regulation.
- Learn the key differences between the EU and US submission routes.
- Grasp the fundamentals of the 8+2+1 data exclusivity rule and its impact on launch strategy.
- Recognise the main regulatory procedures (Centralised, Decentralised, MRP, ANDA, 505(b)(2)).
- Appreciate the importance of developing a Right-First-Time regulatory strategy to remain competitive.
Register for the free Module 1 by completing the form below. You will be sent joining instructions and more information about the course (agenda, trainers, pricing etc).