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Revised Version of French Research Standard MR-003 Published

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...

Research Involving Human Beings in France – Impact on NIS

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...

French Sunshine Obligations Clarified and Extended

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...

France's New Requirements for Clinical Research – Refreshing Clarity or Regulatory Nightmare?

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...

France – Changes in Approval Requirements for NIS

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...
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