Post Graduate Certificate in Regulatory Affairs

Next start date, January 2023 | Fee $1650

Introduction

All countries have government agenciies responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. The ensure the development and subsequent supply chain for medicines and medical devices are safe and secure. Therefore all pharmaceutical companies have regulatory departments that work to meet local and international regulatory requirements.

This PG Certificate delivered by FCD in partnership with UWC is a 20 South African Credit / 10 ECTS course that covers the core topics professionals working in regulatory affairs should know. It also teaches a subject becoming increasingly important, especially in the development of medicines: Health Economics. Together, both modules give students the skills to help regulate the development and distribution of safe and efficacious medicines and the ability to understand economic environment so new and existing medicines are as accessible as possible, especially where the burden of disease is highest.

Why Study this Program?

Support your career in an area where there is a great need for qualified professionals.

Gain the skills to contribute to the the development, licensing and ongoing pharmacovigilance of medicines.

Learn to apply evidence-based thinking to solve many of the challenges regulators must resolve.

Learn from renowned world leading experts in an area in high demand.

Possible path to the PG Diploma in Regulatory Sciences and M.Sc. in Pharmacy Administration and Regulatory Policy for those who do not meet normal entry criteria.

Award Title
Post Graduate Certificate

Program Duration
10 Weeks

In Partnership with
University of Western Cape

Entry Requirements

Applicants with any of the following qualifications may be considered for acceptance:

Four-year degree in pharmacy – [e.g., BPharm or BSc (Pharm)].

Degree in medicine or allied discipline.

Four-year degree in science (e.g., BSc Hons).

Three-year degree in science plus one years’ relevant work experience. 

Three or four-year degree in a non-scientific subject plus one years’ relevant work experience.

Applicants without these qualifications may be considered if they can show suitable motivation and a high potential to positively contribute to the course. Consideration will be based on academic merit and appropriate experience.

What will I Study?

This 10 week online Post Graduate Certificate blends self-directed study with Tutor-led team-based learning. Throughout the course, you’ll engage in:

State of the art teaching via on-demand interactive lectures.

Learning through real world case studies, online group tutorials and team work.

Assessments that directly simulate the challenges faced when considering typical regulatory challenges.

Modules

This program consists of the Regulatory Affairs Module plus one other module currently offered as part of the Regulatory Sciences program, this currently includes Ethics, Leadership, Clinical Trials and Statistics, Health Economics, How to Evaluate a CTD, Pharmacovigilance, Medical Devices, Traditional and Complementary Medicine.

Please note, although the certificate will take a total of 10 weeks to complete, start and finish dates will depend on the module you select as your elective as it may be scheduled at a different time during the year. Please contact Alice@fcdcollege.com for more information. 

Regulatory Affairs

Elective

Program Benefits

Graduates will receive a Post Graduate Certificate delivered by FCD in partnership with the University of the Western Cape a world leading, research-led, learning and teaching university with a legacy of social justice, community engagement and graduate employability.

Designed and delivered by leading experts with a global perspective.

You can study while balancing existing family and work commitments.

No need to travel as the program is online, available anytime, anywhere, on any device.

This certificate is a possible pathway to the PG Diploma in Regulatory Sciences or PG Diploma in Clinical Operations, especially for those who do not meet the normal entry criteria.

Post Graduate Certificate in Regulatory Affairs
Post Graduate Certificate in Regulatory Affairs