TMQA Latest News

Addendum I to GVP Module XVI Released for Consultation

Addendum I to Good Pharmacovigilance Practice (GVP) Module XVI was released by the EMA last month for public consultation. The deadline for comments is 30 June 2015 with Q4, 2015 being the expected date for coming into effect. GVP Module XVI relates to educational materials. This addendum provides guidance for marketing authorisation holders on the submission of draft education materials to the competent authorities of the EU Member States as well as guidance for these competent authorities on the assessment of these materials, particularly regarding format and content, and guidance on publication of educational materials by marketing authorisation holders on specific websites. In line with the release of this addendum, the introductory cover note on GVP was updated.

FDA Publishes BIMO Inspection Metrics

The FDA recently published the annual bioresearch monitoring (BIMO) inspection metrics for fiscal year 2014. The inspectional data covers all aspects of the FDA’s BIMO program, including clinical investigators, institutional review boards (IRBs), sponsors, bioequivalence and good laboratory practices (GLP) for all centres (ie. CBER, CDER, CDRH, CFSAN, CVM). A summary of the metrics from inspections of clinical investigators, IRBs, sponsors/monitors/CROs is provided below:

  • Clinical investigators - 58% resulted in no action indicated (NAI), 37% resulted in voluntary action indicated (VAI) and 5% resulted in official action indicated (OAI). The most common deficiencies were as follows:

o   Failure to follow the investigational plan and/or regulations

o   Protocol deviations

o   Inadequate record keeping

o   Inadequate accountability for the investigational product

o   Inadequate communication with the IRB

o   Inadequate subject protection – failure to report AEs and informed consent issues.

  • IRBs – 50% resulted in NAI, 45% resulted in VAI and 5% resulted in OAI. The most common deficiencies were as follows:

o   Inadequate initial and/or continuing review

o   Inadequate SOPs

o   Inadequate membership rosters

o   Inadequate meeting minutes

o   Quorum issues

o   Subpart D issues

o   Inadequate communication with CI/institution

  • Sponsors/monitors/CROs – 57% resulted in NAI, 35% resulted in VAI and 8% resulted in OAI. The most common deficiencies were as follows:

o   Inadequate monitoring

o   Failure to bring investigators into compliance

o   Inadequate accountability for the investigational product

o   Failure to obtain FDA and/or IRB approval prior to study initiation.

EMA to Screen Medical Literature for Active Substance Groups

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.

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.