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.