EMA Consultation - Reflection Paper on GMP and MAHs

12th February 2020

The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.

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MHRA Guidance Update: Notified bodies for medical devices

5th February 2020

MHRA Guidance Update: Notified bodies for medical devices

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Meeting highlights CHMP, Jan 2020

5th February 2020

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020

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UK withdrawal from the EU on 31 January 2020

31st January 2020

The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.

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Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use

22nd January 2020

Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use. The purpose of the document is to set out the terms of reference, including objectives, scope, requirements and general principles of an international inspection pilot programme covering manufacturers of sterile medicinal products.

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HMA-EMA Joint Big Data Taskforce Updates

21st January 2020

The HMA and EMA have released more information from their joint 'Big Data Task Force'.

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MHRA Inspector Recruitment

17th January 2020

The MHRA have produced a blog to give you the information you need to consider if applying for future roles.

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2019 Risk Management Standard for Medical Devices ISO 14971:2019

8th January 2020

The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle.

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EMA Management Board: December Meeting Highlights

3rd January 2020

The EMA's Management Board met in December for their 106th meeting.

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MHRA GCP Non-Commercial Symposium 2019

23rd December 2019

The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. There was a change of format as a result of feedback received at previous events therefore this year the symposium was smaller and focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites). The event was popular with approximately 250 delegates attending.

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