This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.
This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.
Previously, Salma has worked for Chiesi-Torrex, Wyeth Whitehall and for Croma Pharma, where she was director of supporting operations, supervising regulatory affairs and compliance, change control and lifecycle management, pharmaceutical editing and packaging and the medical department. Michor Consulting has served among others such clients as Johnson & Johnson, Novartis, Valeant Pharma, Baxter AG, Almirall, UCB and Colgate Palmolive.
This course is relevant for anyone working within the field of regulatory affairs at management level or above, such as:
I enjoyed learning through the case studies. The course content was excellent.
The interaction and questions asked from fellow participants was useful.
Discussing with other students local ways of working was really helpful.