News Archive

MHRA - Medical device stand-alone software including apps

17th May 2023

MHRA have updated 'Medical device stand-alone software including apps' to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.

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WHO - calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs)

17th May 2023

The World Health Organization (WHO) is calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs) to protect and promote human well-being, human safety, and autonomy, and preserve public health.

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EMA - CTIS newsflash

10th May 2023

5 May 2023

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EMA - Questions and Answers about the raw data proof-of-concept pilot for industry

10th May 2023

Scope, terms of participation and data submission process

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EMA - Review of transparency rules for the EU Clinical Trials Information System (CTIS)

10th May 2023

EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.

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EMA - SME Office Newsletter 58

10th May 2023

The newsletter for micro-, small- and medium-sized enterprises (SMEs),

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EMA - Statement from Emer Cooke on the end of the COVID-19 public health emergency

10th May 2023

On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about what this means for EMA.

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FDA - Additional Steps to Advance Decentralised Clinical Trials

10th May 2023

The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

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FDA - Q9(R1) Quality Risk Management

10th May 2023

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”

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MHRA - Good Manufacturing Practice Symposium 2023

10th May 2023

A write up of the event by Graham Carroll

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