• Completed application form.
• Curriculum Vitae.
• A Bachelor’s degree (accompanied by a transcript) in a field related to Pharmacy, Chemistry, Medicine, Veterinary, Biology from an accredited institution of higher education.
• A short statement (approximately one page) of personal goals and professional interests.
• Evidence of knowledge of the English language (I.E.L.T.S band score ≥ 6.5 or equivalent).
• Two recommendation letters (one preferably from a University Professor).
• Other documents that might support the application (e.g. articles, books, awards).
• Documentation on previous working experience in the Pharmaceutical Industry (if applicable).

The admissions process includes an interview with the candidate.

Course assessment usually comprises of a comprehensive final exam and continuous assessment. Continuous assessment can include amongst others, weekly interactive activities, projects, positive online forum participation etc.

Letter grades are calculated based on the weight of the final exam and the continuous assessment and the actual numerical marks obtained in these two assessment components. Based on the course grades the student’s semester grade point average (GPA) and cumulative point average (CPA) are calculated.

The student must complete 90 ECTS and all programme requirements.

A minimum cumulative grade point average (CPA) of 2.0 is required. Thus, although a ‘D-‘ is a PASS grade, in order to achieve a CPA of 2.0 an average grade of ‘C’ is required.

Upon successful completion of this program, the students should be able to:

1. Critically evaluate the requirements for obtaining Marketing Authorization for medicinal products and medical devices in the EU, US and Emerging Markets.
2. Independently initiate and carry out proper actions between regulatory authorities and the marketing application authorization applicant/holder.
3. Critically examine and evaluate scientific data and conclusions intended for regulatory review.
4. Appraise the regulatory documentation and systems.
5. Adapt to changing guidelines and regulatory systems.
6. Interpret and critically analyze complex regulatory requirements, legal and ethical obligations and construct and communicate regulatory strategy to colleagues.
7. Operate as an effective team member or leader in interdisciplinary teams or multi-agency teams.
8. Critically appraise of research/evidence in the field of pre-clinical and clinical development planning and submission.
9. Design and conduct of regulatory training sessions for leaders and employees.
10. Appraise the process of evaluating risks and assess the risk/benefit ratio.
11. Analyze Type I and Type II variations.
12. Analyze the concept of pharmacoepidemiology and how it affects drug approval and postmarketing activities.
13. Summarize the basic drug design & development process.
14. Critically examine the concept of signaling in Pharmacovigilance.
15. Critically evaluate regulations in several countries/regions.

Semester 1

Semester 2

Semester 3