EU Pharmacovigilance Legislation & Risk Management November 21-22, 2013, Budapest Hungary

Date: Aug-21-2013The new EU legislation for Pharmacovigilance advanced many aspects of Pharmacovigilance to new levels above and beyond the already comprehensive Vol IXa. 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 requirements and expectations. The 15 new modules are designed to elevate Pharmacovigilance activities to an integrated and risk based assessments of products, processes and how people are trained in the Company to implement both routine Pharmacovigilance as well as implementing processes to minimize and manage Risks to patients.

This course is intended to provide a breakdown of the various modules and provide practical examples of how to perform the various activities what the Regulators want to see for the enhanced Regulatory Inspections that are already occurring.

The Benefits of attending the course?

To understand what needs to be in place practically to perform the various pharmacovigilance activities and how they relate to other Departments in the Company.

Discover solutions on current market trends concerning:
The Legislation Outline for 1235/2010 & 2010/84
The Impact on ICSR Safety
Reporting in Europe
Compliance monitoring
Regulatory Quality Assessments - what and why
Electronic versus Paper reporting - immediate changes and proposed
PSURs and DSURs
The PV Master File
The New Legislation and Quality Management (QM)
The responsibilities of the license holder and QM
The Role of the EU QP PV & Country Representatives
CCSIs; SPCs; & Additional monitoring
Safety Variations and Urgent Safety Restrictions
Additional monitoring, specialist ADR forms & RMPs
Risk Management Plans (RMPs) & PASS
Signal Detection Activities
Audits & Risk Based Inspections
And more issues to be discussed

Attendees who fit the course

This course would be suitable for PV professionals, EU QPPVs, QA & Compliance, Regulatory, Drug Safety and those in the Clinical & Post-marketing arena.

Further information: http://amstadglobal.net/life-science/32/event_details

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.