Safety of Medicines – University of Copenhagen

Safety of Medicines - From Non-Clinical Development to Pharmacovigilance

The content of this course covers the regulatory issues concerning medicines safety from non-clinical and clinical development up to post marketing pharmacovigilance, with emphasis on regulatory issues in the post-authorisation phase.

The course content includes

  1. non-clinical safety studies including methods for assessing safety in vitro and in vivo (animals).

  2. principles of safety monitoring in clinical phase I, II and III studies. This includes in vivo pharmacology, PK/PD aspects, the observation of adverse events and their assessment (causality and seriousness).

  3. pre-authorisation tasks concerning safety documentation, preparation of clinical study protocols and execution of clinical studies with focus on the collection and reporting of safety data (development safety update reports, DSUR).

  4. pharmacovigilance and risk management activities after marketing (phase IV), including spontaneous reporting, signal detection, periodic safety update reports (PSUR), benefit-risk assessment, planning and conduct of post-authorisation safety and effectiveness studies, and the implementation of risk minimisation measures.

  5. regulatory requirements and processes concerning medicines safety both before and after marketing authorisation, including the roles of regulatory bodies (EMA, PRAC and CHMP, FDA), EU and international guidelines (GVP, ICH).

After completion the student will be able to account for, scientifically discuss, advise on and evaluate the role of non-clinical, clinical and epidemiological scientific safety assessments and related regulatory requirements as the basis for the continuing safety assessment of medicines.

Course dates

  • 14-18 May 2018

Exam date

  • 15 June 2018 (online)

Application deadline

  • Extended deadline: 26 April 2018

Course fee

  • DKK 16,000 for EU/EEA citizens
  • DKK 18,750 for non-EU/EEA citizens