by Syneos Health_1 | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE
Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...
by chuck_ltd | 11 Oct, 2017 | Brexit
On Saturday 4 Oct, the European Commission (EC) published its assessment of the bids by 19 Member States to host the European Medicines Agency (EMA) when it relocates from London in March 2019. As instructed by the Member States, the EC has been careful to avoid...
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 | 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...
by chuck_ltd | 9 Mar, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE –...
