TMQA Latest News

DATA INTEGRITY IN CLINICAL TRIALS CONFERENCE

More than half the places on the DATA INTEGRITY conference being co-organised by TMQA in Bratislava on 13th June have been taken up .

Please click here for further information (in Slovak language)

To reserve your place, please use this Registration Form


TMQA STAFF PUBLISH IN "QUASAR"

Katarina Eghan and Karen Martin have published "COMPLIANCE - QUO VADIS?". The article is copyrite RQA and first appeared in Quasar #143.

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NEW TEAM MEMBER

We are delighted to announce the Rita Silvestre will join our Discovery and Development team on 1st May. Rita has been working at Q2 Solutions and she holds masters degrees in Medical Biotechnology and Molecular Parasitology. Rita is Portugese and expands our language capabilities not just in Protugese but also Spanish.


APRIL REGULATORY NEWS ISSUED

  • 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.
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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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