by Mark Heinemann | 6 Feb, 2020 | CHCUK News & Articles, Consultation, Data Privacy, News, NIS, PASS, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Intelligence
2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug...
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...
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 | 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...
