by chuck_ltd | 22 Aug, 2018 | CHCUK News & Articles, Data Privacy, Informed Consent, NIS
France – Health Research and Data Protection: Lawmakers Revise Research Standard MR-003 “Research in the Field of Health Without Collection of Consent” By Mark Heinemann, Principal Consultant, Real World Clinical Consulting, Syneos Health The French Data Protection...
by chuck_ltd | 3 Mar, 2017 | CHCUK News & Articles, NIS, NIS Considerations Report
Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537. The law describes the modalities for...
by chuck_ltd | 30 Jan, 2017 | CHCUK News & Articles, Sunshine Regulations, Transparency
The long-awaited decree that clarifies the French “Sunshine” obligations was recently published in the French Official Gazette, and it brings about some important changes to the existing transparency requirements that apply in the life sciences sector in...
by chuck_ltd | 22 Nov, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News
Note – Amended text in RED Décret n° 2016-1537 du 16 novembre 2016: publication in the French Official Journal of a decree concerning research involving the human person Decree No. 2016-1537 of 16 November 2016, published in the Official Gazette of 17 November...
by chuck_ltd | 30 Sep, 2016 | CHCUK News & Articles, News, NIS
Guest Contributor – Mark Heinemann, Principal Regulatory Specialist, Late Stage, InVentiv Health Clinical The French Ministry of Research and Higher Education (MESR) informs in a recent update of its website...
