Introduction to European Regulatory Affairs
Optimising time-to-market is an increasingly critical requirement for pharmaceutical companies who arechallenged by shrinking pipelines. Tighter standards imposed by regulatory authorities have almost certainly
contributed to a drop in the number of products being launched globally each year.
Are you looking for ways to improve your regulatory affairs activities and optimise drug submission procedures?
This course will provide you with a clear understanding of the EU regulatory structure and ensure that your
submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.
Who should attend - Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
- Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
- Anyone wishing to update their knowledge on European regulatory affairs
- Regulatory Affairs, Registration and Documentation assistants/officers/managers
