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German RECs Seek to Simplify NIS Approval

by chuck_ltd | 9 Apr, 2018 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Registry

Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the...

Revision 2 of GVP Module VI Becomes Effective 22 Nov 2017

by chuck_ltd | 29 Aug, 2017 | CHCUK News & Articles, PASS

GVP Module VI, which deals with the collection, management and submission of reports of suspected adverse reactions to medicinal products has been amended. Revision 2  comes into effect on the 22 November 2017. Revision 2 boasts 144 pages versus the 90 pages of...

EMA – Post-authorisation safety studies: questions and answers

by chuck_ltd | 22 Jul, 2017 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Real World Evidence

The recently updated EMA page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in...

6th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology – July 2017

by chuck_ltd | 8 Jul, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence

The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website and includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments...

GVP Module VIII – Revision 2 Published

by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, GVP, News, NIS, Real Word Evidence

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...
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