Introduction to EU Regulatory Affairs
This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. After three days you will have a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators.
Through interactive exercises you will gain a practical insight into the European legal and regulatory environment, the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical approach that will enable you to apply what you have learned to your daily work.
Suitability - Who should attend?
- Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
- 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)
- Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers
- Those in other areas of the pharmaceutical industry such as development or manufacturing
- Project Management who would find knowledge of the regulatory environment useful.
Training Course Content
- Speed-up the MAA through effective selection of your drug registration procedure
- Integrate CTD requirements from the start of your submissions
- Gain faster responsesfrom the regulators through better negotiations
- Compile and present the key information in your submission dossiers more efficiently
- Maintain your license by performing post-approval obligations on time
- Reduce early, or late stage, setbacks in the registration procedure by anticipating questions from regulators
- Improve your dossier compilation process through a systematic data collection strategy
- Facilitate your drug’s successful review by preparing a strong clinical profile
- Take into consideration the patent situation when working on abridged applications
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
Average rating 5
This course provided a very detailed overview of the subject matter. I enjoyed the way the course was delivered, the knowledge and the enthusiasm of the trainer. She was a fanta...
I enjoyed the practical sessions. There was a clear overview of the EU regulations and it provided me with tools and guidelines to look at - very helpful.
The friendly environment and knowledge which was shared along with the resources were very helpful. Great organisation.