EU Pharmacovigilance & Risk Management, 13th & 14th March 2014, Vienna

Date: Nov-25-2013The 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.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.