A Guide to Pharmacovigilance in the EU

Research and Markets (researchandmarkets.com/reports/c8588) has announced the addition of A Guide to Pharmacovigilance in the EU. to their offering.

(PRWEB) November 4, 2004 -- Although the legislative framework for pharmacovigilance has not changed significantly in the last two years, there are still many companies, especially smaller organizations, which appear to struggle to meet these requirements.

All companies have a statutory obligation to seek information about potential problems in the use of their medicinal products - it is not an option. Failure to do so can result in criminal prosecution against individuals in the company.

It is vital that all companies with EU marketing authorizations have mechanisms in place for obtaining, recording, storing, and submitting suspected adverse drug reactions to the regulatory authorities in the countries in which the authorizations are valid. This requirement applies to both national authorizations obtained through the mutual recognition procedure and EU-wide authorizations obtained through the centralized procedure.

Scope of the Guide - This Guide provides a thorough evaluation of pharmacovigilance issues that is essential for all those in regulatory affairs, clinical studies, post-marketing surveillance, and all aspects of the maintenance of marketing authorizations in the EU. In addition, the Guide offers detailed information to assist those requiring a primer to effectively carry out their roles in pharmacovigilance and related activities.    

Questions Answered: - Who is involved in the collection, management, distribution, and analysis of suspected adverse drug reaction information? - What is the legislative framework for pharmacovigilance in Europe? - What are the reporting requirements for suspected adverse drug reactions for all products approved in the EU irrespective of the method of product registration? - Why is pharmacovigilance so important to the maintenance of safe medicinal products on the market and to public confidence in the industry and its products? - How do the marketing authorization holders and the regulatory authorities deal with concerns about particular medicinal products?

Target Audience: This Guide will benefit the following professionals who have or are seeking to obtain marketing authorizations within the EU: Regulatory Affairs, Clinical Research, Directors, Group Leaders, Project Managers, Heads of Research & Development, Business Development, Marketing, Consultants, and more

1. Introduction 2. Brief Historical Perspectives 3. Legislative Framework 4. Eudra Vigilance 5. ADR Reporting Requirements for Companies 6. Reporting Requirements in Special Situations 7. Spontaneous Reporting 8. Prescription Event Monitoring 9. Statistical Analysis of ADRs 10. Periodic Safety Update Reports 11. Company-Sponsored Post-Authorization Safety Studies 12. Pharmacovigilance Evaluation Post-Authorization 13. Managing and Maximizing a Data Source for Pharmacovigilance: The General Practice Research Database (GPRD) 14. The Future for Pharmacovigilance

For more information visit http://www.researchandmarkets.com/reports/c8588

Laura Wood
Senior Manager
Research and Markets
press@researchandmarkets.com
Fax: +353 1 4100 980

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