Continuing to adopt the experience of European colleagues.
In Barcelona, the training “PHARMACEUTICAL DOCUMENTS IN THE LIFE CYCLE OF MEDICINAL PRODUCTS: DSUR, RMP, PSUR / PBRER and ACO” took place.
Further training, PHARMAGATE specialists have improved their knowledge in such aspects as:
• Pharmacovigilance drug life cycle
• Benefit and risk analysis
• Signal management and data collection
• Development Security Update Report (DSUR)
• Periodic Security Update Report (PSUR) / Periodic Risk and Benefit Assessment Report (PBRER)
• Risk Management Plan (RMP)
• Clinical Review Appendix (AddCO)
• Assessment of documents
• Referrals
• Planning, gap analysis and preparation of photovoltaic documents.
Despite the fact that the course is based on EU requirements, several relevant ideas were provided on the most relevant local requirements.
