Introduction
This post graduate diploma builds on the post graduate certificate in clinical research operations developed by FCD College in collaboration with the Global Health Clinical Consortium (GHCC), the Institute for Global Health at the University of Siena, Italy, Strathmore University, Kenya, and the University of the Western Cape, South Africa.
The main focus of this diploma is on the successful operation of clinical trials and research sites within the context of the ethical, regulatory and economic environments all clinical research must operate in.
Graduates will learn many skills making them valuable members of any clinical trial team.
If you take this diploma, you will gain a thorough understanding of the clinical trial process from project management to protocol design to quality systems.
The students on this diploma typically work at clinical research sites, hospitals, CROs or pharmaceutical companies. Students are physicians, nurses, pharmacists, scientists and members of staff already working in some area in clinical development. Many students come from different industries and wish to move into clinical development.
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 clinical development of medicines that meet unmet medical needs.
Learn to apply evidence-based thinking to a range of challenges those working in clinical operations 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 those working in clinical research and allied professions, for example regulatory affairs.
Modules
This program consists of the following modules.
Ethics
Regulatory Affairs
Generics & Biosimilars
Health Economics
Clinical Trial Mgt. & Stats
Leadership & Negotiation
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 70 South African credits. The M.Sc is a 180 South African credit program. This is subject to availability and a final decision by UWC.

