We are delighted to announce that Lynsay McTaggart has been promoted to a Senior Associate specialising in GLP and GMP. Sadly, Fiona Connolly has now left TMQA to pursue a career as a CRA. We wish Fiona all the best in her new job.
TMQA has been selected to exhibit at the SQA Annual Meeting
We are delighted to have been selected as an exhibitor at the 31st SQA Annual Meeting.
This is the third year running TMQA have exhibited at this event and it gives our team a great opportunity to meet existing and potential clients as well as the chance attend informative sessions on a broad variety of topics in GLP, GCP and GMP. www.sqa2015.org
MHRA website moves to www.gov.uk
As of 28 January 2015, the MHRA website can be found on the gov.uk website. The official MHRA web address is: www.gov.uk/mhra. As part of the move, the content of MHRA has been rewritten so it is easier and clearer to understand. Bookmarks and saved links to the old MHRA website will still take you to the information you need. You’ll automatically be redirected to the relevant content on www.gov.uk.
MHRA helps Eisai develop its first European site
The MHRA has helped the Japanese pharmaceutical company, Eisai, to develop its first European research and production site. This is the third case study by the Innovation Office at the MHRA. The Innovation Office was established in 2013 to help support the UK Prime Minister’s Life Sciences strategy and was developed as a place that those developing medicines and devices could turn to if they didn’t know who to contact at the MHRA for advice.
In the case of Eisai, by involving the MHRA inspectorate early in the design stage of their research and production site, it ensured that the development met the regulatory requirements for the type of site, which included a number of innovative concepts and design philosophies. The MHRA helped by: attending advisory meetings to facilitate quick decision making; reviewing the conceptual approach to make sure it was on the right track; providing invaluable feedback at an early stage; helping Eisai to mitigate risk and avoid expensive changes to design later on in the process; working to support Eisai in ensuring compliance.
FDA issues guidance agenda on new and draft guidances it plans to publish in 2015
Earlier this month the FDA’s Center for Drug Evaluation and Research (CDER) published a list of new and revised guidances that it plans to publish during 2015. Those relating to clinical trials include, but are not limited to:
- Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
- Multiple Endpoints in Clinical Trials
- Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
- Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers
The full list can be found on the FDA website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf