The document discusses guidelines for pharmacovigilance in clinical trials and post-marketing. It outlines responsibilities for monitoring safety, reporting adverse events, and taking action if new risks emerge. Marketing authorization holders must establish systems for safety reporting, literature review, and responding to regulators. Competent authorities conduct inspections and oversight to ensure compliance.

2. Treatment may be worse than the disease

3. During the 1990’s, the deaths of two healthy volunteers in the US made their way to the highest political levels and forced a review of protection of human subjects. Ellen Roche 24 year old Healthy Volunteer Asthma study Jesse Gelsing er 18 year old Healthy Volunteer Genetic Study

4. In March of 1994, the U.S. Office of Research Integrity announced that Dr. Roger Poisson from Montreal admitted having falsified data (99 cases) in a breast cancer clinical trial sponsored by the U.S. National Cancer Institute (NCI). This well-intended falsification compromised the contribution of hundreds of women enrolled in the protocol as all data from the 389 patients enrolled by Dr Poisson were removed from the analysis. Dr. Roger Poisson

6. We need sound science, ethics and safety in clinical trials to sustain the trust of government, public and, especially, the research subjects.

8. Thus, in order to have complete assessment of the drug in real life setting, safety reporting in post-authorisation era or pharmacovigilance is equally important.