TMQA`s monthly Regulatory News update has been published.

• MHRA Pharmacovigilance inspection trends
• New data protection requirements from May next year
• New version of Eudravigilance

TMQA December Regulatory News

5^th Global QA Conference

TMQA has started a blog (http://www.tmqa.co.uk/blog.php) to give visitors coming to Edinburgh an insight into the attractions they can visit when attending the conference. You can also e-mail us at 5GQAC@TMQA.CO.UK and we will try to answer your questions about your visit to Edinburgh

Shona Ross has suggested films that might get you into the mood. Edinburgh is increasingly the setting for global blockbusters and her blog lists some to put you in the Edinburgh Mood.

Edinburgh also has a long literary heritage and Shona suggests some Edinburgh locations that are easy to visit in feature in the work of authors from JK Rowling to Robert Louis Stevenson.  Read Shona’s ‘Films to get you in the Mood for Edinburgh’ and ‘Edinburgh in Books’ blogs

Cate Ovington is based in Yorkshire but explores all the best running when she is visiting our Edinburgh office. She shares details of three memorable runs in her ‘Running in Edinburgh’ blog.

Our Director, Andrew Waddell, prefers something a little less energetic now and he shares some of his favourite walks in the ‘Views of Edinburgh’ blog. There is also advice about `Travelling in Edinburgh`

The TMQA team hopes you enjoy these blogs – and keep coming back as we will be posting more content including where to eat, drink and relax in Edinburgh and things to do if you are spending a little more time when you are in the city.

 Enjoy the TMQA BLOG

This month’s Regulatory News update includes:

• BIA and MHRA Publish Report “Innovation in Life Sciences in a Changing and Dynamic Environment”
• MHRA Launches Introductory Guide to Medical Device Regulations
• EMA Publishes Draft ICH E9 (R1) Addendum for Consultation

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)

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