News Archive

FDA-NIH - Glossary for Clinical Research

21st June 2024

Open for comment now.

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ICH - M14 Guideline Available for Comment

21st June 2024

ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.

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EMA - Faster access to clinical trial information in Europe

18th June 2024

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.

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EMA - Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape

17th June 2024

Article co-authored by EMA.

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EMA - Generating clinical evidence for treatment and prevention options for long COVID

17th June 2024

Article co-authored by EMA

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MHRA - Guidance Released Machine learning medical devices: transparency principles

14th June 2024

13th June 2024

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MHRA - Updated Guidance Software and artificial intelligence (AI) as a medical device

14th June 2024

This guidance provides access to important Software Group outputs that might be of assistance.

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EMA - ACT EU launching two advice pilots

13th June 2024

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today (10th June 2024) launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.

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FDA - Research on AI/ML-Based Medical Devices

13th June 2024

CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.

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ICH - Assembly Meeting

13th June 2024

ICH Assembly Meeting Write Up, Fukuoka, Japan, June 2024 The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The ICH continues to expand and welcomed ANMAT, Argentina and JFDA, Jordan as new ICH Members, bringing ICH to a total of 23 Members and 35 Observers.

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