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Post Graduate Award in Pharmacovigilance

Pharmacovigilance covers the safety and risk issues one must address to ensure patients receive safe drugs. This course will give students a working knowledge of all aspects of drug safety monitoring and risk management, enable them to predict and analyse drug interactions and recognise the implications for prescribing and product license. The student will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans, and will be fully cognizant of regulatory reporting requirements.

Application Status
Open for October 2022

Study Mode
Flexible study concept with self-study and live webinars
Certificate with exam and 10 ECTS

12 weeks
300 hours: 30 contact hours (live webinars) and 270 of directed self-learning.

Course Fee

Course Leader
Dr. Thuy Mason

Course contact for further information

Loji Thebe
T: 0121 345 9847

Awarding Institution
College of Medicine and Dentistry

Course Details

After successfully completing this course, students will be able to:

Understand and critically appraise the principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue, explain key operational drug safety definitions, demonstrate good pharmacovigilance practice and locate key sources of information and documentation. They will be able to comprehend and discuss global pharmacovigilance, understand drug development and discuss the risks and safety assessment. Additionally, the students will possess the skills to critically explain the strengths and weakness of pharmacovigilance reporting systems and future challenges in drug safety and pharmacovigilance.

The entry requirements for the course are:

(a) A level 6 degree in Pharmacy, Biomedical science, Medicine or equivalent,

(b) Competence in written and spoken English

  • Historical aspects and evolution of drug safety
  • Safety of Drugs
  • Risk assessment and risk management
  • Absorption, distribution, metabolism and excretion (ADME)
  • Device safety
  • Collecting and reporting drug safety information
  • Audit and inspection
  • Pharmacovigilance planning
  • Regulatory requirements and legislations in the EU and MENSA
  • Future challenges in drug safety and pharmacovigilance

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