• Updated reference safety information guidance
• International collaboration on oversight of API manufacturing
• FDA guidance of inclusion of pregnant women in clinical trials
• Redistribution of UK`s portfolio of centrally authorised products.

Our monthly Regulatory Affairs Update for March has been published:

• MHRA publishes `GxP` data integrity rules
• Updated guidance on publication of clinical trial results
• EMA adopts revised guideline on Alzheimer`s disease trials
• FDA rule on data from clinical investigations of medical devices

Our monthly Regulatory and Pharma News Update for February has been published and can be accessed at this address 

Highlights include:

• HMA publishes guidance on Reference Safety Information;
• MHRA opens consultation on exemptions to the Medical Device and In-vitro diagnostics regulations;
• MHRA publishes advice on use of pharmacovigilance service providers;
• EMA and MHRA provide guidance on preparation for Brexit;
• Use of form FDA 1572 in trials in Europe;
• FDA launches clinical trial transparency programme

TMQA is runing its popular Research Quality Assurance training course at its Edinburgh facility on 26th and 27th March.

This is a great chance to learn about audit and inspection from leading experts in the field. For further information please click on the `Read More` button below.

The January Edition of our popular Regulatory Update is now available:

• EMA Management News
• MHRA Clinical Stakeholders Engagement Meeting
• Highlights from the ICH Assembly
• TransCelerate publishes new eConsent Guidance and Tools

Dowload your copy here - January Regulatory Update