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.
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
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
There are no prerequisites for this course. It can be attended by anyone interested in regulatory affairs.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.