Regulations and Guidelines for Pharmacovigilance
Regulations and Guidelines for Pharmacovigilance
Venue: Wellcome Collection Conference Centre, Euston Road, London
Date:
25 - 26 Apr 2012
Cost per delegate:
£1,050.00 + VAT
or
£685.00 + VAT (academic units, public sector organisations, registered charities)
Course Outline
Introduction
Preparations are underway to update pharmacovigilance regulations and guidelines as part of the new EU Pharmacovigilance Legislation, which comes in to force during 2012. Currently pharmacovigilance regulations are assembled in Volume 9A of the Rules Governing Medicinal Products of the EU – Guidelines on Pharmacovigilance for Medicinal Products for Human Use, dating from 2007. Under the new legislation, Directive 2010/84/EU outlines the requirements of Good Pharmacovigilance Practices, which will replace Volume 9A during 2012-2013, forming the foundations of practice of pharmacovigilance in both the pharmaceutical industry and regulatory authorities. This course will cover the development and requirements of Good Pharmacovigilance Practices (GVP), as well as other aspects of the new legislation.
Aims
- To explore the law and guidance defining EU Pharmacovigilance requirements and issues associated with their current interpretation
- To analyse the operational aspects of case processing, from receipt to electronic reporting, both for individual cases and the construction of aggregate reports such as Periodic Safety Update Reports (PSURs)
- To review critically, the qualitative aspects of the pharmacovigilance system such as quality assurance, audit, compliance, post-authorization safety studies signal detection, risk management and communication
- To explore critically, the role of the Qualified Person in Pharmacovigilance (QPPV)
- To analyse the impact of licensing agreements on pharmacovigilance
Key Topics
Programme features
- Development of Good Pharmacovigilance Practice (GVP)
- Timetable for implementation and requirements of GVP
- Pharmacovigilance System Master Files
- Update of PSURs, Risk Management Plans and PASS
- Inspections
- Reporting of adverse drug reactions
Learning Outcomes
- Analyse and explain the expectations and scope of the EU pharmacovigilance system
- Choose, justify and assemble the appropriate tools and manage the processes necessary to facilitate regulatory compliance
- Appraise the role and responsibilities of the QPPV
- Critically discuss the broad issues associated with licensing agreements