Author Archive | s_mccully

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Electronic healthcare databases in Europe: Descriptive analysis of characteristics and potential for use in medicines regulation

Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. This paper provides insight into available EHDs to support regulatory decisions on medicines. A Few European databases meet minimal regulatory requirements and are readily available to […]

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GDPR

Compilation of Guidances on the EU GDPR

The US Office for Human Research Protections (OHRP) has compiled a very useful list of the country-by-country guidelines and supporting information on the impact of the EU General Data Protection Regulation (GDPR) If you are new to the General Data Protection Regulation, you may want to review the text of the regulation to familiarize yourself […]

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Revised Version of French Research Standard MR-003 Published

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 Agency CNIL recently published a revised version of the French Research Standard MR-003 “Research in the Field of […]

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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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Digital-Medicine

Trump Administration Announces MyHealthEData Initiative at HIMSS18

The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed to putting patients first, and that’s why we approach issues with healthcare […]

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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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MHRA – Guidance on GxP Data Integrity

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, for example, via third party service providers. Systems […]

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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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