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Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
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News Archive
FDA - Q9(R1) Quality Risk Management
10th May 2023The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”
MHRA - Good Manufacturing Practice Symposium 2023
10th May 2023A write up of the event by Graham Carroll
MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
10th May 2023The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.
MHRA - Implementation of the Future Regulations
10th May 2023The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
MHRA - Publication Scheme
10th May 2023The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making transparency and accountability to the public a fundamental principle of how we do business.
MHRA Blog - Ensuring Child Vaccine Safety at Every Step
10th May 2023Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.
Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers
10th May 2023Clarification of the requirements for the submission of audit reports
MHRA - Good Distribution Practice Symposium 2023
2nd May 2023Held on 21-22 February 2023 - here is write up of the event.
EMA - CHMP Highlights 24 - 26 April 2023
27th April 2023Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
EMA - CVMP Meeting Highlights 18-20 April 2023
26th April 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
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