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Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power

by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...

EU: EMA Initiative for Patient Registries – Strategy and Pilot Phase

by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, News, NIS, Publication Guidelines, Real Word Evidence

Problem statement Regulators may require marketing authorisation applicants/holders (MAAs/MAHs) to establish a registry in order to measure the safety or efficacy of individual products in routine clinical practice. Various challenges with regard to registries...

Czech Republic: HCP Disclosure – an Extraordinary Experience from the “Wild East”

by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines

We are on the cusp of introducing a mechanism to disclose value transfers between health professionals and EFPIA Member Companies. But, with the June 2016 deadline looming, learning from those who are already experiencing this form of transparency could save us...

EU: Harnessing the Power of Health Data Whilst Preserving Patients’ Privacy and Trust

by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines

Although the Big Data revolution is only in its early days, the potential for value creation is huge in the healthcare sector. Not only can clinical data help us to understand diseases and develop therapies; it can also drive the transition towards modern health...

SWEDEN: Sweden’s experience adopting the EFPIA Disclosure Code

by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, News, NIS, Publication Guidelines

The EFPIA disclosure code was transposed in to “The Ethical rules of the pharmaceutical Industry in Sweden” from 1 January 2014. Parallel to this actual code transposition, LIF also informed important stakeholders about the initiative trough meetings and personal...

US: FDA is Soliciting Input on the Use of Technology and Innovation in Clinical Research

by chuck_ltd | 29 Oct, 2015 | CHCUK News & Articles, GCP, Publication Guidelines

FDA is soliciting public input from a broad group of stakeholders regarding technologies and innovative methods for using technology to more efficiently conduct clinical research. FDA is interested in identifying new opportunities to study medical products, as well as...

UK: HTA Codes of Practice and Standards Consultation

by chuck_ltd | 28 Oct, 2015 | CHCUK News & Articles, HTA, News, Publication Guidelines

Rationale The Codes have been revised to provide a clearer flow of information, and there are now fewer documents that establishments need to refer to. The Codes of Practice on Disposal (Code 5) and Import and Export (Code 8) have been incorporated into the sector...

Global: Version 3 of Good Publication Practice for Communicating Company-Sponsored Medical Research Released (Sep 2015)

by chuck_ltd | 8 Oct, 2015 | CHCUK News & Articles, Data Privacy, Publication Guidelines

Version 3 of Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP3) was published on 15 September 2015. This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for...

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