Clinical Evaluation of Drug Products

  • Gitte Bonke Seigan (Participant)

    Activity: Participating in or organising an event types › Participation in workshop, seminar, course

    Description

    Course: The course objectives are to provide a general introduction to practical, methodological and regulatory aspects of drug trials in humans. The course is not a GCP course. The clinical development phases will be presented, along with non-clinical studies that are a direct prerequisite for clinical trials. Other topics, which will be covered, include: Clinical trial protocol. Clinical trial methodology. Randomised clinical trial. Pharmacovigilance. Health economics. Data management. Statitics in clinical trials. Quality assurance. Regulatory guidelines. Regulatory drug approval process. Evidence-based medicine and ethics in clinical drug trials.
    Period21 May 2012 → 25 May 2012
    Event typeCourse
    LocationCopenhagen, DenmarkShow on map