Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Phone: (M) +45 6141 8634 Linkedin

    Course: 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.

    Dates: 20-24 May 2019 
    Time: 5 days
    Venue: University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N

    Costs: EU/EEA citizens Non EU/EEA citizens
    Master student DKK 13,000 DKK 15,000
    Singe course student DKK 15,000 DKK 17,000

    Application deadline: 13 March 2019

                                                                                    READ MORE & SIGN UP

    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

    Continuing and Professional Education