Course description
Essentials of European Pharmaceutical Regulatory Affairs
This course will provide a basic, comprehensive grounding in pharmaceuticalregulatory affairs in a relaxed and interactive environment.
This popular course provides an opportunity that on-the-job learning doesn't: network and learn from a variety of experts, including your fellow participants.By attending this course, you will:
- Get a clear understanding of the roles played by regulatory affairs professionals obtaining and maintaining marketing authorisation for medicines
- Learn the key steps involved in developing new pharmaceuticals
- Gain an overview of EU legislative framework and regulatory procedures
- Get insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders
- Understand life-cycle management procedures including variations, the essentials of clinical trials and importance of labeling
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Suitability - Who should attend?
Suitable for
This course is designed for those:
- Who are new to regulatory affairs
- Who wish to move into the profession
- From related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
- Who would gain by obtaining better insight about the world of their partners in regulatory affairs
- Those who work in regulatory authorities and those in the regulatory sector
Outcome / Qualification etc.
Benefits to participants
- Get a complete grounding in regulatory affairs in just one day
- Be taught by regulatory affairs experts with extensive practical examples
- Understand the regulatory affairs sector and find out for yourself how you can maximise your performance, either as a regulatory professional or working alongside regulatory colleagues
- Build a network to support the rest of your career
Training Course Content
- Introduction
- Setting the Scene
- Overview of Drug Development
- Regulatory Control of Clinical Trials
- Marketing Authorisation Applications
- Product Information (Labelling)
- SmPC game
- European Marketing Authorisation Procedures
- Marketing Authorisation Strategy
- Post- Authorisation Activities
- Review
- Millionaire Quiz
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