News Archive

EMA - International regulators and WHO join forces to address COVID-19 challenges

18th November 2020

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible.

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Launch Event ISO 22095 ‘Chain of Custody’

18th November 2020

ISO 22095 ‘Chain of Custody – General Terminology and Models’ has been published in October 2020, after three years of dedicated work from international chain of custody experts from industry associations, private companies, civil society organizations, governments and scheme owners. ISO 22095 is a simple solution that works across all sectors and with all materials and products. The new international standard allows users to effectively reduce their costs and address a multitude of issues caused by the present variety of chain of custody systems. Please find the ISO press release here. We will celebrate the publication of this horizontal standard in an international webinar ‘Launch of ISO 22095 on Chain of Custody’. The event will take place on the 9th of December 2020 at 14:00 hrs Brussel time zone (CET). Programme of the webinar: Content and highlights ISO 22095 ‘Chain of Custody’ – Mr. Adrian Henriques (projectleader) Case studies on how different organizations will implement the standard. Q&A session with experts that have been closely involved in the standard development process. You are cordially invited to join this webinar and share the information within your relevant netwerk. Please register yourself via this link. In case of any other questions related to this launch or the work of ISO/PC 308, please do not hesitate to contact the NEN Secretariat - Ms. Anne-Wil Broersma (anne-wil.broersma@nen.nl).

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MHRA - Building resilience into clinical trial design and conduct during the pandemic

18th November 2020

On 19 March, the MHRA first produced guidance for researchers on managing clinical trials of investigational medicinal products (IMPs) during the pandemic. This guidance constituted details about a collection of established flexibilities and technologies that are available, but little used, despite their regulatory acceptance.

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WHO - Good practices for research 6 and development facilities

18th November 2020

Draft document available for comment.

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020

4th November 2020

PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines

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EMA - Clinical Trial Information System (CTIS) webinar

3rd November 2020

An EMA Clinical Trial Information System (CTIS) webinar (dynamic demo of sponsor workspace) took place on 21 September 2020. Materials are currently available to participants who registered to attend via DIA, however EMA have indicated that they plan to make the demonstrations publicly available on their website at a later date, as part of their wider training of CTIS users and Sponsors.

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MHRA - Registering to make submissions to the MHRA from 1 January 2021

23rd October 2020

The UK has left the EU, and the transition period after Brexit comes to an end this year. The Agency is making preparations to ensure that you can continue to submit regulatory and notification information to the UK.

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EMA - virtual conference: 25 years of advancing public and animal health

21st October 2020

On 22 October 2020, EMA will mark 25 years of its strong commitment to protect public and animal health with a virtual conference. The event will be broadcast live on EMA’s website.

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