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Pages dedicated to these focal RQA groups.More information
EDQM - Contribute to shaping the future EDQM strategy – Stakeholder survey
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.
ICH - Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022
Consultation with healthcare professionals: please complete our consultation to help influence how MHRA communicate with you
MHRA - Drug Safety Update for Nov 2022 updated.
MHRA Blog Post - Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments
UKRI to launch AI CDT call.
EMA Consultation Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems.
EMA Consultation Draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy.
EMA Consultation The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.