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Download our GCLP White Paper

Analysis of samples from clinical trials must comply with the relevant Good Clinical Practice regulations and guidelines. However, these contain no specific guidance regarding the procedures and standards required for valid analytical results.

Read more by downloading our White Paper on Quality Systems for Clinical Trial Samples (or Good Clinical Clinical Laboratory Practice)

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Download the latest issue of TMQA's Regulatory News Update

This issue includes:

  • MHRA issues GCP Inspection Metrics report
  • EMA issues Press Release related to Brexit
  • EMA issues revised Guideline on First-in-Human Trials
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Have you been asked to implement a Quality Management System?

In many industries, leaders have traditionally viewed a quality management system (QMS) as an additional burden and cost on a business – ‘quality’ owned the system.  This view is still widespread from where standards are necessary to where they are not. Often the mantra ‘it is only R&D therefore quality doesn’t apply’ being the norm and acceptable practice. However, due to significant errors within scientific and non-scientific organisations in recent times which have reached national and international headlines, quality has become high profile. This has led to more calls for establishing quality systems where previously there was no appetite for one. 

TMQA`s technical toolkit on Quality Management Systems in Non-Regulatory Areas is a practical guide to help you get started with designing a QMS bespoke to your organisation`s business and regulatory needs.  Download a copy by clicking on the link below.

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TMQA Regulatory News Update - July 2017

This month’s regulatory news update includes:

  • EMA Issues Guidance for Industry to Prepare for the UK’s Withdrawal from the EU
  • FDA Publishes Draft Guidance on Use of Electronic Records and Electronic Signatures in Clinical Investigations
  • MHRA Updates Information on when a CTA is Needed

 

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TMQA Regulatory News Update - May 2017

This issue of our regulatory news update includes:

  • MHRA publishes guidance on common issues with Clinical Trial Applications
  • FDA publishes updated Compliance Pogramme Guidance Manual
  • EMA and Head of CAs discuss consequences of Brexit
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