UK: NRES Website Closing Soon (14 Aug 2014)

The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries. The information previously found on the NRES website can now be found on the website of the Health Research Authority (HRA). […]

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UK: NHS REC Booking & Submission Changes (14 Aug 2014)

NHS REC Booking & Submission Changes – Implemented 19 May 2014 The HRA has changed the processes for applying to Research Ethics Committees (RECs) to improve its service and make the booking and application process more straightforward for researchers. The key changes that have been introduced are as follows: NEW Central Booking Service (CBS) for […]

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EU: Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published (14 July 2014)

The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP […]

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Ireland – The Irish Medicines Board (IMB) is now the Health Products Regulatory Authority (HPRA) (01/07/2014)

On 1 July 2014, the Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA). Established in 1996, the IMB name has served us well. However, over the last 18 years our regulatory remit has expanded to include other health products as well as a number of health related functions. In addition […]

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Impact of New EU Clinical Trials Regulation on UK Approval System (17/06/2014)

On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU). The regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical trials in Europe. Applicants will now submit a single application for a clinical trial, regardless of the number […]

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EU: EMA Releases Best Practice Guidance on Parallel Scientific Advice with Health-Technology-Assessment Bodies (08/05/2014)

Guidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies. The document is a key outcome of the EMA-HTA workshop on parallel scientific advice, which took […]

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