Safety of Medicines - From Non-clinical Development to Pharmacovigilance

The course will introduce you to:

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).

This course introduces regulatory safety requirements covering non-clinical and clinical development as well as the post-authorisation phase. You will be able to explain the principles and management of pharmacovigilance before and after authorization including risk-benefit assessment and risk management, and identify the timing and requirement of non-clinical, clinical and post-authorisation safety studies for both small molecules and biopharmaceuticals.

During the course, you will learn to plan and make decisions with regard to non-clinical development and documentation, review and assess global safety data at all phases of drug development and post-authorisation, and take responsibility for continuous risk-benefit assessment, pharmacovigilance, and risk management.

Lastly, you will be able to integrate all safety aspects when assessing drug candidates for selection during clinical development and market authorisation approval.

Innovate and strengthen the regulatory process  

The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience
• Be proficient in English

Find detailed information about the admission criteria.

• • Course responsible:
    Morten Andersen

Course lecturers
Torbjörn Callréus, University of Copenhagen, Denmark
Allan Dahl Rasmussen, Lundbeck A/S, Denmark
Lene Grejs Petersen, Danish Medicines Agency, Denmark
Andrew Bate, Pfizer, Denmark
Jon Trærup Andersen, University of Copenhagen, Denmark
Maurizio Sessa, University of Copenhagen, Denmark

This course is offered as a compulsory part of Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.