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 | 3 Mar, 2017 | CHCUK News & Articles, News, NIS, NIS Considerations Report, Regulatory Intelligence
The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on...