News
MHRA GCP Guidance for Clinical Trials
On 31st July 2020 MHRA updated “Good clinical practice for clinical trials” on their website available here. Guidance for the notification of serious breaches of GCP or the trial protocol, [...]
Pharma News Update July 2020
COVID-19 Vaccine Development Dynavax and Medigen Announce Partnership for a Novel Adjuvanted COVID-19 Vaccine Candidate On 23rd July 2020, Dynavax Technologies, a biopharmaceutical company focused on developing and commercialising novel [...]
Regulatory News Update July 2020
Medicines and Healthcare products Regulatory Agency (MHRA) Updates on MHRA Regulatory Flexibilities resulting from Coronavirus (COVID-19) guidelines The MHRA issued additional updates to the guidelines in July 2020. Information for [...]
Our New Training Courses
Tower Mains is pleased to announce training courses to help you, your employees and colleagues stay up to date with the latest practices, standards and guidelines are now on our [...]
A comparison of the EMA, FDA and MHRA guidance on the conduct of clinical trials during the COVID-19 pandemic
Printed in July's 2020 issue of RQA's Quasar Global regulatory authorities acknowledge the impact and increasing pressure that the COVID-19 pandemic is putting on global health care systems. Against this [...]
Introducing Tower Mains and a new website
Who are we? Tower Mains Ltd was first established in 2001 as an independent Research Quality Assurance consultancy that became widely known as TMQA. Our core business was conducting audits [...]
Regulatory News Update June 2020
COVID-19 Updates Medicines and Healthcare products Regulatory Agency (MHRA) Dexamethasone - World first coronavirus treatment approved for NHS use by government On 16th June 2020, the MHRA issued a press [...]
Pharma News Update June 2020
COVID-19 Vaccine Development Oxford University’s COVID-19 Vaccine Boosts Immune Response in Pigs On 23rd June 2020, the Pirbright Institute in collaboration with the University of Oxford announced that two doses [...]
Tower Mains COVID-19 Support Services
Introduction and Areas of Services In the current COVID-19 situation, the EMA has provided guidance that on-site audits should, in general, be avoided or postponed. However, the ICH Guideline on [...]
Regulatory News – COVID-19 Special Edition April/May 2020
Medicines and Healthcare products Regulatory Agency (MHRA) MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK On the 26th May 2020, the MHRA gave [...]
