Research and Markets : A Guide to Pharmacovigilance in the EU.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c8584) has announced the addition of A Guide to Pharmacovigilance in the EU. to their offering 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 medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. - 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 adverse drug reaction, n a detrimental outcome from a drug. Two types of ADRs exist: Type 1 results from dosage mismatch and Type 2 from rare conditions often as a consequence of a small dose. See also risk or sensitive type. to the regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities 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 cen·tral·ize v. cen·tral·ized, cen·tral·iz·ing, cen·tral·iz·es v.tr. 1. To draw into or toward a center; consolidate. 2. procedure. Scope of the Guide - This Guide provides a thorough evaluation of pharmacovigilance issues that is essential for all those in regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: prep. Without consideration of; regardless of. irrespective of preposition despite 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 ADR - Astra Digital Radio Reporting Requirements for Companies 6. Reporting Requirements in Special Situations 7. Spontaneous Reporting 8. Prescription Event Monitoring In computer science, event monitoring is the process of collecting, analyzing, and signalling event occurrences to subscribers such as operating system processes, active database rules as well as human operators. 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 GPRD General Practice Research Database ) 14. The Future for Pharmacovigilance For more information visit http://www.researchandmarkets.com/reports/c8584 |
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