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These documents can be found on the Periodic safety update reports: Are you sure you want to continue? Draft note for guidance: Once the
updated GVP module is published this guidance will be removed. Definitions and standards for expedited reporting - Step 5. Module VI
Management and reporting of adverse reactions to medicinal products Rev. Close Dialog Are you sure? GVP modules I to XVI cover major
pharmacovigilance processes and the development of this set of guidance is concluded. EudraVigilance Human version 7. Module IX Addendum I
Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions. Public consultation of good
pharmacovigilance practices. This action might not be possible to undo. Product- or population-specific considerations I: Document s Language
Status First published Last updated Effective Date Guideline on the exposure to medicinal products during pregnancy: Clinical safety data
management: Module XVI Risk minimisation measures: Module X Additional monitoring. Two more considerations chapters are planned
as follows: Module V Risk management systems Rev. Pharmacovigilance planning - Step 5. Guideline on good pharmacovigilance practices
GVP - Module VI Collection, management and submission of reports of suspected adverse reactions to medicinal products Rev. Discover
new books Read everywhere Build your digital reading lists. Vaccines for prophylaxis against infectious diseases. The chapters on product- or
population-specific considerations have been developed for vaccines and biological medicinal products. Related links For other templates
developed outside the GVP process, see: Guideline on the exposure to medicinal products during pregnancy: Related links These
pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP. For other
pharmacovigilance guidance developed outside the GVP process, see: Buy the Full Version. Close Dialog Join the membership for readers Get
monthly access to books, audiobooks, documents, and more Read Free for 30 Days. An agency of the European Union. Are you sure you want
to delete this list? These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in
conjunction with GVP. Introductory cover note, last updated on 12 October Annex V Abbreviations Rev. Module III Pharmacovigilance
inspections. Guideline on good pharmacovigilance practices: Two more considerations chapters are planned as follows:. Home Human regulatory
Post-authorisation Pharmacovigilance Good pharmacovigilance practices. Guideline on conduct of pharmacovigilance for medicines used by the
paediatric population. Screen Reader Compatibility Information Due to the method this document is displayed on the page, screen readers may not
read the content correctly. Also remove everything in this list from your library. Annex II Templates: Modules covering major
pharmacovigilance processes GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is
concluded. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. EudraVigilance access
policy for medicines for human use. Cover page of periodic safety update report PSUR. Module I Pharmacovigilance systems and their quality
systems. Maintenance of the ICH guideline on clinical safety-data management: These documents should be considered as interim guidance until
the GVP VII module is revised as per the established process. You're Reading a Free Preview Pages 2 to 5 are not shown in this preview.
Guidelines on good pharmacovigilance practices GVP: Related links CHMP guideline on safety and efficacy follow-up - risk management of
advanced therapy medicinal products. Overview of comments received on draft note for guidance: Where GVP modules refer to the European
Medicines Agency's and the Heads of Medicines Agencies' procedural advice on referral procedures for safety reasons, consult referral
procedures page. Document on reporting requirements of marketing authorisation holders in the EU regarding suspected adverse reactions
occurring with medicinal products they donate outside the EU to public health programmes against neglected tropical diseases. Guideline on good
pharmacovigilance practices GVP: