On Tuesday, 27 November 2012, CIOMS held the 79th session of its Executive Committee (EC). The EC endorsed the general ambition to identify new issues of major relevance for the medical community where there is a need for review and global adoption of common principles and standards and to increase the interaction with member organizations and involvement of members of the EC in the activities of CIOMS, and to promote the work of CIOMS.
The Secretary-General presented a summary of the most important events and achievements over the year.
The programme for 2013 was also presented within the area of Drug Development and Use.
The following were specifically identified:
- to initiate a new CIOMS Working Group (WG) on vaccine safety in collaboration with WHO
- to disseminate the published work of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance;
- to, following the renewed memorandum of Understanding ( MoU) 11 November 2012 between the ICH MedDRA management Board (ICH-MMB) and CIOMS, continue activities concerning Standardised MedDRA Queries (SMQs), particularly the development of Home Grown SMQs and the work on the revision/update of the “Red book” publication “Development and Rational Use of Standardised MedDRA Queries (SMQs)”
- The aim to produce the final report of the work by CIOMS WG IX
- To continue the work of CIOMS WG X; and
- To continue the distribution of past working group publications
The possibility of initiating an additional CIOMS WG apart from the new Vaccine WG was also discussed. This discussion was based on recently published article by Furlan G. in Drug Safety. The focus of this article is the proposal of developing to merge the PSUR, DSUR, RMP Safety Specification and Signal detection assessment report into one single Drug Safety Master File that could also be used for answering the questions of regulators within the context of a referral and serve as a basis for identifying the risks to be included in a formal benefit/risk assessment report. To obtain worldwide consensus the author proposes that this could become a topic to be addressed by a CIOMS Working Group.
The EC considered the proposal with great interest and decided to further elaborate on this proposal.
The programme for 2013 was also presented within the area of Research Ethics. The following were specifically identified:
- To continue the initiated revision of the 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects;
- In collaboration with ICLAS publish the revised and updated International Guiding Principles for Biomedical Research Involving Animals;
- To continue the distribution of CIOMS ethics publications; and
- To continue to promote CIOMS through participation in international and national forums
The next EC meeting will be held Wednesday, 20 November 2013 in Geneva. This will also be the date of the General Assembly of CIOMS which includes elections of new members of the Executive Committee