Why join CAPRA as a student?
Come to a CAPRA educational event
- Check the Meetings tab for upcoming events
Meet and network with industry professionals
Introduction to Regulatory Affairs and the Regulatory Affairs Profession
Regulatory Affairs or RA is a relatively new profession that has developed in response to increased legislation set forth by governments to protect public health, regulating the quality, safety and efficacy of products such as pharmaceuticals, veterinary medicines, medical devices, agrochemicals, cosmetics and natural health products. Companies responsible for the discovery, testing, manufacture and marketing of therapeutic products want to ensure that the products that they make are safe and can be produced for sale. Most companies, whether they are multinational pharmaceutical corporations or small biotechnology companies have a RA department, and those who don't generally rely on the advice of independent regulatory consultants to meet their legal obligations.
Advances in science and technology, and changes in political environments, the healthcare sector and economics in general, shape the dynamic and expanding scope of the RA professional. RA professionals play key roles in the development, approval and surveillance of safe and effective healthcare products worldwide, ensuring compliance with applicable laws and regulations. RA professionals are typically responsible for the presentation of documents to regulatory agencies, as well as the negotiations necessary to obtain and maintain marketing authorization for the products concerned. They provide strategic, legal, scientific, and technical advice throughout the product lifecycle, including input on restraints, requirements and options, making an important contribution to the success of a regulated therapeutic product.
The specific roles of RA professional vary, depending on the size of the company, the type of products, and where they are to be made, tested or sold.
Interested in entering the Regulatory Affair profession? Here are some useful links to read up on the Profession.
- Click to download: Introduction to RA
A Day in the Life of a Regulatory Professional
Take a look at some interviews conducted by students with a variety of Canadian Regulatory Professionals
Are you a student interested in writing an article profiling a RA professional?
If so, please contact the Student Relations Committee Board Lead: firstname.lastname@example.org
|Heather Graham||Judith Halmos-Stark||Janet Holden|
|Aideen Kennedy||Amélie Lacroix||Dominique Laniel|
|Lorinda Loftonbrook-Phillips||Milan Patel||Austin Nam|
|Beverly Pond||Stephen Sherman|
Useful Tools for the new Regulatory Professional
Frequently Asked Questions
Click here for the 5 most frequently asked questions by Regulatory Affairs students.
The following sites are some educational institutions that offer regulatory affairs courses:
- Academy of Applied Pharmaceutical Sciences
- Humber College
- Seneca College
- Toronto Institute of Pharmaceutical Technology
- University of Montreal
- Northeastern University Toronto
Recognized educational institution offering training and development courses to individuals planning to enter the field of regulatory affairs wishing to be added can contact the Student Relations Committee Board Lead: email@example.com
CAPRA Committees and Student Volunteer Opportunities
To volunteer for a CAPRA committee, please contact the respective Board Lead.
Contact information for CAPRA committees and Board Lead can be found at: CAPRA/ACPR COMMITTEES
Regulatory Affairs Websites
Please see the following section of the CAPRA website for useful Industry links: http://www.capra.caen/students/links-and-resources
Comments and Questions
If you have any questions or comments for the Student Relations Committee please forward them to us through the Contact Page.