This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.
Benefits of Attending
- Understand the Legal Basis of the EU Regulatory Environment
- Discuss Development Strategy and Pre-Submission Activities
- Review Procedures for Applying for a EU Marketing Authorisation
- Discuss Post Authorisation Strategic Considerations and Obligations
Why you should attend
You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post authorisation strategies and obligations.
It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements.
Who Should Attend:
This course is for you, particularly if involved in:
- Regulatory affairs
- Project management
- Business planning
- Commercial Managers
- Manufacturing and QA
- Labelling and artwork
- Medical information
For more information about this conference visit https://www.researchandmarkets.com/research/sx8t8g/eu_pharmaceutical?w=4