TMQA Latest News

REGULATORY NEWS UPDATE

The September and October Edition of the Regulatory and Pharma news has been published. Highlights include:

  • Efforts are amplified to ensure medical supply post brexit.
  • MHRA to consult on EU exit no deal legislative proposals.
  • HRA published a joint statement with the MHRA on seeking & documenting consent using electronic methods.
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REGULATORY NEWS UPDATE

The July and August edition of the Regulatory and Pharma News Update has been published and can be accessed here. Highlights include:

  • Effect of a `no agreement` Brexit;
  • EMA programme restrictions;
  • Updated ABPI Phase I Trials guidance;
  • FDA releases Biosimilars Action Plan.

July and August Regulatory News


TMQA WELCOMES NEW TEAM MEMBER

TMQA is pleased to announced that Dr Maxim Bunimovich has joined our team. Maxim is a medical doctor with extensive experience in clinical research and Quality Assurance. He has joined our Clinical QA team, headed by Katarina Eghan.


LABORATORY REGULATORY UPDATE

TMQA has published the latest of its periodic laboratory updates:

  •  MHRA Gudance on Data Integrity
  • OECD Document on Characterisation and Use of Test Items
  • MHRA Deficiency data for 2017/2017
  • Correction and Corrective Actions
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MAY CLINICAL REGULATORY NEWS

Our monthly clinical regulatory update has been published:

  • MHRA publishes GCP Inspection metrics
  • Guidance on Eudralex Volume 10
  • EMA publishes annual report for 2017
  • Changes to application for a clinical investigation of a medical device
  • FDA Adopts ICH Q7 Guidance
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