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CHCUK News & Articles

eConsent

Transcelerate eConsent Initiative

While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based.  Given the inefficiencies in the traditional process and the increasing complexity of clinical studies, the current approach at times may raise challenges with respect to quality, compliance, patient understanding and trial retention. The […]

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German RECs Seek to Simplify NIS Approval

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 simplification of the ethical evaluation of Non-Interventional Studies (NIS). A number of University and State Medical Association Ethics Committees take part […]

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CombinationProduct

FDA – Postmarketing Safety Reporting for Combination Products

This DRAFT guidance addresses how to comply with the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,” “final rule,” or “rule”).  The rule describes how to comply with PMSR requirements for combination products that have […]

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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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New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv Health Clinical Spain S.L. In July 2017, FDA issued this guidance for immediate implementation. Link to the Guidance: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf The […]

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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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How far do the medical device rules affect health-related apps?

Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing.  But deciding exactly when software will be categorised as such a device is not so straightforward.  An Opinion from an Advocate General […]

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