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...
by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
New ENCePP Guidance on Conducting Systematic Reviews and Meta-Analyses of Completed Comparative Pharmacoepidemiological Studies of Safety Outcomes Annex 1 to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Introduction (Highlights from the ENCePP Plenary Meeting, 24 November 2015) Xavier Kurz set the scene by presenting a brief introduction highlighting ENCePP’s potential role and contribution so far to the regulatory need for continuous monitoring and investigation of...
