Regulatory course
Introduction to Regulatory Affairs
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.
Dates and booking
Choose your date.
No dates are scheduled right now. Join the waiting list below, ask us about the next session, or ask about an in-house course for your team.
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Leave your details and we will email you as soon as new dates are published. No commitment.
Who it’s for
Is this course for you?
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
There are no prerequisites for this course. It can be attended by anyone interested in regulatory affairs.
What you’ll learn
About this course.
Learning objectives
- Explain regulatory affairs and its different areas of activities
- Explain authorisation pathways
- Identify key players and their roles
- Learn trends in regulatory
Programme highlights
- 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
Your trainer
Your trainer.
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
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