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...
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...
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...
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...
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...
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...
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...
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...
