Scientific and medical literature is an important source of information to identify suspected adverse reactions on medicines. The EU pharmacovigilance legislation has given the European Medicines Agency (EMA) responsibility for the monitoring of selected medical literature for a defined list of active substances used in medicines and for entering identified reports of suspected adverse reactions in Eudravigilance, the EU adverse drug reaction collection and management system. This medical literature monitoring service to be provided by the EMA, with support from a contractor which the EMA has selected, will start with a limited number of active substances on 01 July 2015 and will be fully rolled out in September 2015. The EMA has published a list of active substances and a reference to the journals that will be covered by this new service. The aim of this new initiative is to improve the safety monitoring of medicines by enhancing the quality and consistency of data reported in Eudravigilance. It is provided as a service to industry which, for the active substances and literature covered by the EMA activities, will no longer be obliged to enter the information on suspected adverse reactions into Eudravigilance. Individual cases of suspected adverse reactions found in the literature will be made available to marketing authorisation holders so they can include them in their safety databases and meet their reporting obligations outside the EEA. http://tinyurl.com/pjxhkdw
TMQA Director delivers Auditing Skills training to JSQA members
Last month Andrew Waddell travelled to Japan to provide GCP and GLP Auditing Skills training for the Japan Society for Quality Assurance (JSQA). This was a great honour for Andrew, as he is the first person from outside Japan to provide such training to JSQA members.
It was an intensive four days of presentations, group discussions, exercises and of course delightful Japanese hospitality! The feedback from participants was extremely positive with 87% of the GLP course attendees rating Andrew as an excellent trainer. Also, 90% of the participants who attended both the GCP and GLP courses felt that the training should be repeated in the future.
We would like to thank the JSQA Board for giving Andrew this unique training opportunity and to all the JSQA staff for organising two excellent training courses.
“It is a special privilege to be invited to talk about Quality in Japan, the country which has done so much to adopt and develop quality management. It was a great pleasure to deliver this training and hopefully it is the start of a beneficial collaboration between JSQA and TMQA”. Dr Andrew Waddell, Director, TMQA
Shona Ross joins the TMQA GLP Team
We are pleased to announce that Shona Ross has joined our GLP Team as an Associate. Shona has over 11 years experience in pre-clinical and clinical research and joins us from the Global Analytical Services division at Elanco. Shona`s profile is now available on our Team page.
Michael leaves TMQA to become a MHRA Inspector
Michael McGuinness left TMQA last week to start his career at the MHRA. We are delighted that the experience Michael has gained with TMQA over the last 5 years has enabled him to take up this prestigious position. We all miss working with Michael and wish him all the best in his new role.
HRA Announces Start Date for Phased Roll-out of HRA Approval
The Health Research Authority (HRA) will begin the roll-out of the new HRA Approval process on 11 May 2015. HRA Approval is the new process that will be required before research can commence in the NHS in England. It will replace the current local Research & Development (R&D) approval process and will remove the need for NHS permission to be granted by each participating organisation. The new HRA Approval process will comprise a review by a Research Ethics Committee as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. The new system will simplify the approval process for research, making it easier for research studies to be set-up. It will eliminate duplicate application routes and will remove duplication of reviews of research by NHS support teams. There will be a phased roll out of this new HRA Approval process by study type, starting with studies that fall into Cohort 1 (details of the different types of studies that fall into each cohort can be found on the HRA website). The timing of the next roll out phase will be announced once the HRA has reviewed the implementation of the first phase.