Tag Archives | NIS

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Non-Interventional Studies – What is the Biggest Challenge?

Non-Interventional Studies… Q. What is the Biggest Challenge? A. Working out the regulatory requirements for your study! Finding out what’s needed to run a non-interventional study shouldn’t be difficult, but it is! We’ve taken the pain out of that process by collecting the relevant information per country and per study type and captured this in […]

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6th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology – July 2017

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 received were also considered. Due to developments in some areas or need for restructuring and […]

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Germany – Impact of Amendment of the German Drug Act on NIS

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 December 24, 2016 (G. v. 20.12.2016 BGBl. I S. 3048 (Nr. 63)). […]

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Research Involving Human Beings in France – Impact on NIS

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 research involving humans and eventually adds ‘non-interventional research’ to the research law framework. The most recent […]

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

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 2016, is now in force. It specifies the modalities for research involving […]

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France – Changes in Approval Requirements for 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 (https://appliweb.dgri.education.fr/appli_web/codecoh/IdentCodec.jsp) of the modification of the declaration and authorization procedures for the preparation and / or storage of human biological samples for research purposes. […]

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The RWE Equation: Finding the Right Late-Stage Study Design

White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory Consulting, Late Stage, inVentiv Health Clinical Although real-world evidence (RWE) has become increasingly popular for its insight into the use and […]

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GVP Module IX – Consultation Open

Draft guideline on good pharmacovigilance practices (GVP) – Module IX – Signal management (Rev. 1) Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter […]

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