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EMA - High-quality data to empower data-driven medicines regulation in the European Union

19th October 2022

High-quality data to empower data-driven medicines regulation in the European Union.

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022

19th October 2022

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022

19th October 2022

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022

19th October 2022

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022

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ICH - Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2

19th October 2022

The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.

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MHRA - Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety

19th October 2022

Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety. Consultation description The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety. Your Participation You can participate in this consultation anonymously but if you choose to provide your email address, we will add you to our mailing list to offer you future opportunities to hear about or get involved in our work. This questionnaire will take approximately 20 minutes to complete, or longer if you wish to offer additional comments. Please note that you do not have to answer every question and compulsory questions are clearly marked. Ways to respond Respond online

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MHRA - MORE Registrations - user reference guide A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.

19th October 2022

MORE Registrations - A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.

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MHRA - Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools

19th October 2022

Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools

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MHRA - Software and AI as a Medical Device Change Programme

19th October 2022

Software and AI as a Medical Device Change Programme

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MHRA - Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

19th October 2022

Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

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