by Tepsivo | Jun 3, 2021 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction Response from the EMA Our response to the EMA LLS is not cost-effective Current options We need a better solution References Is Local Literature Screening Really Necessary?...
by Tepsivo | May 20, 2021 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction The background of the EU PV legislation 2004 Regulation – “2001-Review” Modernizing Pharmacovigilance The main issues in 2008 “The Problem”...
by Tepsivo | Apr 22, 2021 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Summary What is Local Literature Screening? Why is it a Problem? Communication with the EMA Analysis of EudraVigilance Data EMA 2020 Annual Report on EV Public Data from EudraVigilance...
by Tepsivo | Apr 7, 2021 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction Total Number of ICSRs ICSRs Reported by MAHs and NCAs ICSRs Reported by Patients ICSRs Forwarded to the WHO ICSRs Downloaded by the MAHs Submission Timeliness Compliance...
by Tepsivo | Dec 22, 2020 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction Unique situation for the World and for PV Vaccination approval situation Safety and efficacy of the vaccines BioNTech and Pfizer AstraZeneca Janssen Moderna Gamaleya National...
by Tepsivo | Dec 15, 2020 | Blog
No time to read now? -> Download the article as a handy pdf List of contents Introduction Big plans, no steps Let’s think positive References EMA and Heads of Medicines Agency Final Joint Strategy 2025 Document It is still missing Dominik Hodbod | Dec 15,...
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