Introduction to Regulatory Affairs
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 12/09/2024 | Introduction to Regulatory Affairs | Webinar | EUR 450.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Regulatory Affairs (RA) is essential to ensure that pharmaceutical products can be developed, authorised and maintained on the market and to guarantee that they are aligned with all applicable legislation and regulations. It encompasses a lot of diverse activities and job opportunities, not always known. This course will provide you with a good introduction to what Regulatory Affairs is, its different areas of activities and job functions in the field. This course will be a half-day webinar and you can follow it from wherever you want if you have a good internet connection, camera, and audio.Programme highlight
- Origin of regulation in drug development
- Relevant legislation for drug development
- Authorisation pathways procedures
- EU Regulatory authorities and others
- Roles and responsibilities in regulatory affairs
- Overview of regulatory dossier
- Trends in regulatory processes
- Review of a case study
Learning objectives
- Explain regulatory affairs and its different areas of activities
- Explain authorisation pathways
- Identify key players and their roles
- Learn trends in regulatory
Who should attend
The course is addressed to:
- people new to regulatory affairs who want to acquire a comprehensive foundation
- all collaborators working in relationship with regulatory affairs and wishing to understand the role of the department
- young graduated who are interested to do a career in regulatory affairs and want to know more about it
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design
- Ethical & Participants Safety Considerations
- Investigational Product Development and Regulation
- Clinical Studies Operations (GCPs or ISO 14155)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication
- Teamwork
- Business acumen
Trainers
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