What's On _ CIOMS_

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					Nov 2010                                                                                      Issue 2




                         What's On @ CIOMS!

        CIOMS International Panel
               Discussion
                                                                         SPEAKERS
It is with great pleasure that CIOMS can
announce to our members the speakers in the               Dr Abha Saxena, Staff Scientist and
CIOMS International Panel Discussion in                   Secretary of the WHO Research Ethics
memory of Professor Zbigniew Bankowski on                 Review Committee (ERC), WHO
the topic: The Implementation of ethical
principles in medicine from bench to bedside:
How the physician may integrate the treatment             Dr Dafna Feinholz, Chief of the Bioethics
of his patient with science (research and ethics).        Section, Sector for Social and Human
                                                          Sciences, UNESCO
The panel discussion will be held in the memory
of Professor Zbigniew Bankowski and will take             Professor Elmar Doppelfeld, Past
place on Tuesday 30 November 2010 from 08:45              President of the Steering Committee on
to 11:45 in room M505 at WHO Headquarters in              Bioethics, Council of Europe
Geneva.
                                                          Dr Otmar Kloiber, Secretary General,
A common goal of the organizations represented            World Medical Association (WMA)
in the Panel is to promote the universal
application of Human Rights (UNESCO), the
general principles of the Declaration of Helsinki         Professor Peter Suter, Swiss Academy of
(WMA) and the detailed implementation of those            Medical Sciences (SAMS)
principles in the field, be it private practice,
hospital practice, clinical trials, in developed or       President (tba), International Federation of
developing countries (CIOMS and WHO) with a               Medical Students' Associations (IFMSA)
particular emphasis on the education of medical
students (IFMSA), physicians, medical staff,
investigators and sponsors at the national (SAMS)
and international levels (Council of Europe,
WHO,UNESCO).

CIOMS is most grateful and extremely proud of
the speakers that have agreed to make a
presentation on this day, and look forward to
seeing as many of our members as possible at
this most exciting event.




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Nov 2010                                                                                                Issue 2


        CIOMS WORKING GROUPS
                                                          completed, the WG, being an international
The 11th meeting of the CIOMS/WHO                         vaccine safety initiative, will respond to the
Working Group on Vaccine                                  questionnaire.
Pharmacovigilance, 4-5 October 2010, New
York, USA                                                 Future directions of a restructured WG and scope
                                                          were discussed at the end of the meeting and
Towards a publication!                                    several proposals made. Members volunteered to
                                                          draft a concept paper to be circulated to the rest
                                                          of the WG for comments

                                                          At the end of the first day the participants
                                                          enjoyed the lively Manhattan atmosphere with a
                                                          walk along 42nd Street - resisting the rain!-
                                                          passing monuments such as the Chrysler
                                                          Building and Grand Central.

                                                          Thanks to the WG for a constructive meeting and
                                                          to the hosts for such nice facilities.

This was the final scheduled face-to face meeting                         ---------------------------------
of the group in order to achieve goals according
to the present business plan. The approaching             The 5th meeting of CIOMS Core Group on
publication summing up the work that has been             Standardised MedDRA Queries (SMQs)
made created enthusiasm and the discussions
based on the initial scope of the endorsement of
the Brighton collaboration criteria filled the
agenda of the two days! The working group was
welcomed to the facilities of Pfizer on 42 Street,
Manhattan and enjoyed this central location!
Planned chapters of the publication -apart from
introduction and foreword- will cover areas such
as general definitions, stakeholders’ perspectives,
Brighton collaboration case definitions, methods
to enhance application of Brighton collaboration
case definitions (ie translations, MedDRA                 A very constructive meeting of the Core Group
mapping, references in pharmacovigilance                  (CG) on SMQs was held in Berlin on Tuesday
resources) and finally conclusions and future             28 and Wednesday 29 September 2010. Status of
directions including practical use of general and         SMQs in production/to be released was
the case definitions.                                     addressed as were review of batches and the
Break-out sessions on the definition of                   results of SMQ Survey II. The review of those
vaccination failure and the practical use of              SMQs with all narrow and all broad term
general and case definitions brought energy to            continues and agreement was reached on three
further discussions during the second day.                SMQs. Status update on proposed revision of
The WG was also provided with an update from              SMQ s and projected testing and completion of
WHO on the Global Vaccine Safety Blueprint                SMQs in development were also discussed. A
Project particular on the definition of                   feedback of the status of SMQs in production/to
requirements for minimal capacity of a vaccine            be released and follow-up on SMQ change
pharmacovigilance system. Representatives from            requests were given by MSSO.
the Brighton Collaboration (by telephone link),           An ICH Advisory Panel Meeting took place in
which undertake parts of the project work for             the afternoon of day 1 and feedback from the
WHO, presented the plans for a survey of                  June MedDRA Management Board meeting
minimal capacity in 41 low and middle income              (MMB) in Tallin, Estonia was provided. The
countries and a SWOT analysis of ongoing                  MMB renewed of the Memorandum of
vaccine safety initiatives world-wide. Once the           Understanding with CIOMS for an additional
development of the survey questionnaire is                year (until May 2011). Outreach activities


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Nov 2010                                                                                                Issue 2

continue to the non ICH regions that have                     CIOMS represented at the International
expressed interest in MedDRA.                                 workshop on Clinical Trials and Ethics at
                                                              EMA, London, UK
The meeting took place in the facilities of Bayer
Schering Pharma AG within the centre of the
city. The group experienced a friendly Berlin
with sunny weather. Future directions of the CG
were discussed at the end of the meeting and a
summary of the discussions will be presented to
MMB at the November ICH meetings in Japan
Dates of an additional meeting were reviewed
and members of the CG volunteered to explore
the possibility of hosting it.
A great thanks to the CG for an excellent work                     Dr J.E. Idänpään-Heikkilä & Dr Thomas
and to the host for such a pleasant setting!                                      Lönngren

                                                              The 6-7 September 2010 CIOMS was
                                                              represented by Prof Idänpään Heikkilä and
                                                              Secretary-General Gunilla Sjölin-Forsberg at the
                                                              "International Workshop on Ethical and GCP
                                                              aspects of Clinical Trials of Medicinal Products
                                                              for Human use conducted in third countries and
                                                              submitted in marketing authorization
                                                              applications to the European Medicines Agency
              (Ilona Grosse-Michaelis)
                                                              ( EMA)".
                                                               A Reflection Paper on this issue had earlier been
                                                              submitted for public consultation by the EMA. It
                                                              was with great appreciation that CIOMS noted
                                                              the frequent references within this Reflection
                                                              Paper to some of it’s most recent publications in
                                                              the field of bioethics: the 2002 CIOMS
                                                              Guidelines and the 2009 CIOMS Guidelines for
                                                              Epidemiological Studies.




        UPCOMING TRAVEL/MEETINGS

1-3 Nov 2010       33rd Annual Mtg of Reps of National Centres participating in the WHO Programme for
                   International Drug Monitoring
                   Accra, Ghana
                   (Dr G. Sjölin-Forsberg attending)


3-6 Nov 2010       10th ISOP Annual Meeting "Pharmaco-vigilance in the global village", Accra, Ghana
                   (Dr G. Sjölin-Forsberg attending)


30 Nov 2010        CIOMS ExComm, GA & Panel


1-2 Feb 2011       WG IX, Bayer Schering, Berlin (Fourth)
                   (Dr G. Sjölin-Forsberg and Dr J.E. Idänpään-Heikkilä attending)




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Nov 2010                                                                                      Issue 2




                                              CIOMS Secretariat


   Secretary-General            Senior Advisers                     c/o World Health Organization
   Dr Gunilla Sjölin-Forsberg   Prof. Juhana E. Idänpään-Heikkilä       Avenue Appia
   Tel: 041 22 791 3406                                                 CH - 1211 Geneva 27
                                Mr Sev Fluss                            SWITZERLAND
   Administrative Officer
   Ms. Amanda Owden             Dr Jan Venulet
   Tel: +41 22 791 3467

   Secretary                                                          Fax: +41 22 791 4286
   Ms. Lisa Hodson                                                    Email: cioms@who.int
   Tel: +41 22 791 3413



                                WEBSITE: WWW.CIOMS.CH




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