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R3: RNA, READINESS and RESPONSE

21st July 2021

We need a global network of ‘living’ biofoundries. CEPI (Coalition for Epidemic Preparedness Innovations) and Wellcome Leap are collaborating on establishing a global network of ‘living’ biofoundries.

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EMA - CVMP Meeting Highlights 13-15 July

20th July 2021

Meeting highlights from the Committee for Medicinal Products for Veterinary Use

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MHRA - Dr Alison Cave Starts Vital Vigilance Work

20th July 2021

MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today

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MHRA to hold collaborative workshops with China’s medicines regulator

20th July 2021

The collaboration aims to support China’s regulator in strengthening their regulatory capacity to improve patient access to safe and high-quality medicines and to promote global health security.

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EMA - CTIS Webinar

19th July 2021

Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS

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EMA - Consultation on Guidelines for quality docs

19th July 2021

EMA consultation: Guidelines on the requirements for quality documentation concerning medicinal products in clinical trials

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PIC/S - Document on Data Integrity

19th July 2021

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

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EMA - Guideline on computerised systems and electronic data in clinical trials

30th June 2021

RQA is collating responses to the EMA’s public consultation on the EMA “Guideline on computerised systems and electronic data in clinical trials

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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021

30th June 2021

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021 - CVMP opinions on veterinary medicinal products

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EMA Clinical Trials Information System (CTIS) Newsletter “CTIS highlights”

30th June 2021

Latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter

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