The EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMPstandards for the EU. The EU IG is the basis for submitting and...
The ICH has announced that it will be releasing a Request for Information (RFI) expected in October to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force’s initial...
The Canadian Advanced Therapies Training Institute (CATTI) and the Cell and Gene Therapy Catapult (CGT Catapult) have developed an aligned training and assessment strategy for the advanced therapies manufacturing industry. The strategy is an important...
Secretary of State for Health and Social Care, Victoria Atkins says the department will study the report to make sure lessons are learned. “Yesterday we heard the harrowing conclusion of Sir Brian Langstaff’s inquiry on...
“As part of our evidence to the Inquiry, we apologised unreservedly for any respect in which the blood services of the past, or the blood they supplied, was the cause of suffering to any person....
The EMA updated its EU IDMP Implementation Guide with a revised Chapter 7: Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules. The EU IDMP Implementation Guide (EU IG) for the submission...
The EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMPstandards for the EU. The EU IG is the basis for submitting and...
This new guidance document addresses the use of methods for the standardisation of vector capsid particles in rAAV-based therapies and will provide current best practices. It aims to promote the standardisation of the currently established...
The Food and Drug Administration released final guidance in October that describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) to recognize and use voluntary consensus...
The FDA has announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns. ANSI/AAMI SW96:2023 Standard for medical device security – security risk management for device manufacturers provides...
