The legislation is now supported with comprehensive Pharmacovigilance modules that Affect Pharmacovigilance; Regulatory; Medical Information; QA; Clinical as well affecting the Senior Management view of Pharmacovigilance requirement and expectations. A Good Pharmacovigilance identifies the risks in the shortest possible time of marketing the drug and will help to establish & identify risk factors. You will be provided with a comprehensive, yet practical assessment of the main Regulations required, in producing a compliant reporting Company.
Trainer: Graeme Ladds Managing Director at Pharsafer, UK
Key Sessions:
- The Legislation Outline
- The Impact on ICSR Safety Reporting in Europe
- Changes for EU PSUR submissions
- Risk Management Plans (RMPs) & PASS
- Pharmacovigilance Audits
- The Role of the EU QP PV & Country Representatives
- Risk Based Inspections
- The PV Master File
Who should Attend?
This course would be suitable for PV professionals, EU QPPVs, QA & Compliance, Regulatory, Drug Safety, Clinical & Post-marketing, EU and National Regulatory Affairs Officers, Clinical Risk-Benefit Groups, CROs and many interest parties.
For further details please click here.