Introduction
This diploma, delivered by FCD in partnership with UWC, covers the core topics one must know to effectively lead others within regulatory agencies or the regulatory department of a pharmaceutical company.
The development path of medicines is becoming more complex. Market demands are changing and the research and development process is moving from a finite model to an agile and iterative one which, if designed and managed correctly, will create safer, more effective, and increasingly accessible medicines.
The modules in this diploma explore the key development and regulatory issues a professional in the industry should be aware of. Although the creation of efficacious and safe drugs that meet a medical need must be the primary goal of all those working in the pharmaceutical industry, it cannot be done without reference to health economics. Medicines must also be accessible to all who need them. The health economics module looks at price reimbursement schemes, HTA and OR and describes the economic environment the industry operates in, especially in relation to the challenge to deliver medicines in low-income settings. Ethics considers the major ethical issues affecting the industry from research and development through business and medical ethics. It should also be noted that regulatory affairs and pharmacovigilance are covered throughout the diploma, as well as in their specific modules.
The graduate of this post graduate diploma will typically work for a regulatory agency or in the medical or regulatory affairs departments of a pharmaceutical company. They may work in marketing or portfolio management, possibly with responsibilities around preparing health technology assessments. The student may be a physician, pharmacist or scientist already working in regulatory affairs or is someone who wishes to transition into a role in this area and wishes to gain a thorough grounding in the key topics they are expected to contribute towards.
Why Study this Program?
Enhance your career opportunities in an area where there is a great need for qualified professionals.
Gain the skills to be a valuable contributor during the development, licensing and ongoing pharmacovigilance of medicines around the world.
Learn to apply evidence-based thinking to a range of challenges regulators must resolve.
Learn from renowned world leading experts in a area in high demand.
Award Title
Post Graduate Diploma
Program Duration
12 Months
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.
Three or four-year degree in science (e.g., BSc Hons).
Three or four-year degree in a non-scientific subject plus one years’ relevant work experience.
Post Graduate Certificate in Regulatory Affairs delivered by FCD in partnership with UWC plus two years’ relevant work experience.
Post Graduate Certificate in Clinical Operations delivered by FCD in partnership with UWC plus two years’ relevant work experience.
Post Graduate Certificate in Ethics and Leadership delivered by FCD in partnership with UWC plus two 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 12-month online Post Graduate Diploma 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 by regulators and allied professions, for example clinical development and medical affairs.
Modules
The Post Graduate Diploma in Regulatory Sciences program consists of the following modules.
Ethics
Leadership & Negotiation
Evaluate a CTD
Clinical Trial Mgt. & Stats
Pharmacovigilance
Regulatory Affairs
Generics & Biosimilars
Health Economics
Program Benefits
Graduates will receive a Post Graduate Diploma 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.
Possible path to the M.Sc. in Pharmacy Administration and Regulatory Policy for those who do not meet normal entry criteria.
If you are accepted onto the M.Sc in Pharmacy Administration and Policy Regulation after completing this diploma you may be eligible for exemptions worth up to 90 South African credits. The M.Sc is a 180 South African credit program. This is subject to availability and a final decision by UWC.
