Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe
Clinical trials: Apply for authorisation in UK – MHRA
Guidance on CMC Changes to an Approved Application- US-FDA
Australian electronic Submission Basics Guide- Australia (TGA)
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
Guide to Labels and Leaflets of Human Medicines- IRELAND (HPRA)
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
Open Consultation for EU common standard on electronic product information- EMA
Microsoft to Develop Open-Source Software for the Clinical Research Community