TMQA Latest News

MARCH REGULATORY NEWS UPDATE

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
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FEBRUARY REGULATORY AND PHARMA NEWS UPDATE PUBLISHED

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

Quality Assurance Training

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.

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TMQA Regulatory Update - January 2018

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


Operations Manager Appointed

Lianne Roeling has been acting Operations Manager since Adele McMeekin left in October. we are delighted that she hs now taken the position on a permanent basis.