TMQA Latest News

TMQA Regulatory News Update - December 2016

This month`s TMQA Regulatory News Update includes:

  • ICH Assembly Adopts Amendment to ICH E6
  • MHRA Launches Social Media Campaign for Reporting Suspected Side Effects
  • EMA Provides Public Access to Clinical Reports
Read More »

The latest issue of TMQA's Regulatory News Update is now available

The October 2016 issue includes:

  • An update from the MHRA GCP Symposium 2016
  • UK EU Life Sciences Transition Programme
  • MHRA Inspectorate Blog – Who Inspects the Inspectors?
Read More »

Free places for our Research Quality Assurance training course

TMQA will be running a ‘Research Quality Assurance’ training course on 24th–25th November in Edinburgh (see the news story below). We are offering up to three free places to people who are considering a career move into Research Quality Assurance.

To qualify, you must have a background in scientific research and experience of working in a quality system such as GLP or GCP, ether in a commercial or non-commercial environment. Please write in confidence to  careers@tmqa.co.uk with a copy of your curriculum vitae an a personal statement why you would benefit from this training. All correspondence will be treated in strict confidence and will only be used to select applicants for free places.

Applications must be received by 19th October.


Limited spaces available for our Research Quality Assurance training course in November

 

Research Quality Assurance
2-Day Training Course
24-25 November 2016

 

Who should attend?

The course is aimed at those who are currently working in or wish to consider moving to Research Quality Assurance. It is applicable to anyone who is involved in audit or inspection either within a regulated system such as GLP or GCP or in ‘non-regulated’ research and development.

What will be covered?

The course will cover the entire life-cycle of Research QA Audits and Inspections, including:

 ·         Audit programmes and plans

 ·         Setting up the audit

 ·         Conducting the audit: 

o   The opening meeting 

o   Gathering and analysing evidence 

o   Asking questions and giving feedback 

  ·         Preparing the audit report

 ·       Follow-up and CAPA 

The course is a mixture of presentations and workshops where the participants will get the opportunity to experience the audit life-cycle.

What Will You Get?

Training will be provided by Andrew Waddell, a recognised international expert in Research Quality Assurance. Participants will receive a full set of course notes and a certificate of training. Lunch and refreshments are included.

What is the Cost?

The course costs £ 800 plus VAT. Participants who work for Universities, NHS, Charities or other non-commercial organisations, or who are funding the training themselves, will receive a discount of £200.

How do I apply?

For more information on the course content and application details please email:  adele.mcmeekin@tmqa.co.uk


TMQA's GCP Team expands

We are delighted to welcome Dr Marina Freiberga and Katarina Kovacova to the TMQA team. Marina is based in our Edinburgh office and Katarina in the TMQA Central Europe office in Bratislava.