Clinical Evaluation of Drug Products

  • Gitte Bonke Seigan (Deltager)

    Aktivitet: Deltagelse i eller arrangement af en begivenhed - typer › Deltagelse i workshop, seminar og kursus

    Beskrivelse

    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.
    Periode21 maj 2012 → 25 maj 2012
    BegivenhedstypeKursus
    PlaceringCopenhagen, DanmarkVis på kort