Good Pharmacovigilance Practices
Good pharmacovigilance practices are measures drawn up to facilitate the performance of pharmacovigilance in the European Union. Application of GVP to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities. They include medicines authorised centrally via the Agency as well as medicines authorised at higher level. Pharmacovigilance system defined as the system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect change to their risk-benefit balance.
- Clinical trial safety
- Post-marketing safety
- Regulatory submissions for safety
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Good Pharmacovigilance Practices Conference Speakers
Recommended Sessions
- Adverse drug reactions
- Artificial Intelligence in Signal Detection
- Drug Development
- Drug Safety
- Drug Tolerance
- Good Pharmacovigilance Practices
- Impacts of PV on Covid-19
- Market Research Programs
- Patient Support Programs
- Pharmaceutical Toxicology
- Pharmacokinetics and pharmacodynamics
- Pharmacovigilance
- Pharmacovigilance Operations
- Pharmacovigilance risk management plans
- PV Inspection and Audit Readiness
- Regulatory Efforts
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