WebAug 10, 2016 · Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2) Date for coming into effect of Revision 2 – 9 August … WebGVP Module VIII, marketing authorisation holders ( MAHs) are encouraged to register a PASS (either conducted voluntarily or pursuant an obligation imposed by a regulatory …
Non-interventional Post-Authorisation Safety Studies (NI-PASS): …
WebGVP module VIII on post-authorisation safety studies (PASS) recommends that the Checklist is included as an annex to study protocols. Relevant documents: ENCePP Checklist for Study Protocols (Revision 4) News ; About Us ; ENCePP Documents ; Training in PhEpi and PV ; Code of Conduct ; Web7 - Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and 8 . categories 1-4 of non-interventional PASS described in GVP Module V; 9 - Changes to VIII.B.3.1., adding text in line with GVP Module VI Rev 1 to provide a recommendation on 10 . adverse events that will not be collected or reported; taco shop cmch menu
Non-Interventional Clinical Studies and Real-Life Data
WebVP-201 was established at NAS Norfolk, Virginia on 1 September 1942, under the operational command of FAW5, flying PBM-3 Mariner seaplanes. The squadron was sent … WebFor PASS described in the GVP Module VIII - Post-authorisation safety studies, the Commission Implementing Regulation (EU) No 520/2012 provides legal definitions of the start of data collection (the date from which information on the first study subject is first recorded in the study dataset, or, in the case of secondary use of data, the date ... WebAug 10, 2016 · Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2) Date for coming into effect of Revision 2 – 9 August 2016 Revision 2 contains the following: Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and categories 1-3 of non-interventional PASS … taco shop corporate