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More informationICH M11 guideline (Step 2b), ICH M11 technical specification (Step 2b) and ICH M11 template (Step 2b) - open for consultation.
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022
Procurement at MHRA - Information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.
MHRA - Return to International GMP Inspections
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.
High-quality data to empower data-driven medicines regulation in the European Union.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022