Downloaded 92 times
More Related Content
Similar to CIOMS (1).pptx
CIOMS (1).pptx
- 1.
- 2. What is CIOMS? Councilfor International Organizations of Medical Sciences A. International B. Non-Governmental C. Non-Profit Established jointly by WHO and associate partners of UNESCO in 1949 in a meeting at Brussels. CIOMS is situated in Geneva, Switzerland.
- 3. It representsa substantial proportion of the biomedical scientific community through its biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils. To advance public health through guidance on health research including ethics, medical product development and safety. Forum for discussion and neutral platform to elaborate new ideas in medical product development, Pharmacovigilance and research ethics (bioethics)
- 5. HISTORY 1948 –UNESCO consulted the WHO, thus an agreement between WHO and UNESCO was made for the establishment of a permanent council for coordination of International Medical Congresses. 1949 - Council formally constituted in Brussels by WHO and UNESCO. 1952 - Present name CIOMS adopted. 1959 - Vienna meeting on controlled clinical trials. To discuss the principles, organizations and scope of controlled clinical trials which must be carried out if new methods or preparations used for the treatment of disease are to be accurately assessed clinically. 1977 - Launch of Ethics of Research involving humans. 1982 - Adoption by UN of CIOMS Medical Ethics for prisoners. 1993 - Start of CIOMS focus on pharmacovigilance and reporting adverse drug reactions. 2016 - New CIOMS Ethical Guidelines for Health-related research involving humans.
- 6. Interesting Facts about CIOMS Thegeneral assembly of UN adopted CIOMS principles of medical Ethics related to prisoners in 1983. In 1986- The very 1st CIOMS working group report on Pharmacovigilance. • A working group on International Reporting of adverse drug reactions to explore means of coordinating and standardizing international adverse drug reporting by pharmaceutical manufacturers to regulatory authorities. • Its agenda was limited to post-marketing reporting of adverse drug reactions occurring in one country and which the pharmaceutical industry should report to regulatory authorities in other countries where the drug is also marketed. The world health assembly adopted CIOMS Ethical criteria for medicinal drug promotions in 1994. The longest running CIOMS Working Group- since- 2002- is dedicated to standardized MedDRA Queries (SMQs) CIOMS pharmacovigilance guidelines have been the basis for respective ICH guidelines.
- 7.
- 8. Contact Details Phone: +41(0) 22 791 6497 - Due to the COVID-19 situation we are often working from home. Please contact us by e-mail. Email: [email protected]
- 9. Organization Bioethics Since 1967; CIOMSRound Table Conference “Biomedical Science and the dilemma of Human Experimentation”) Issuance of significant guidelines; latest revision 2016 Focus on “low and middle income countries”; translation into various languages Pharmacovigilan ce 1986 first PV Working Group, 13 more working group reports until today Several ICH Guidelines are based on results of CIOMS Working Groups Product Development Trends and Prospects in Drug Research and Development. Proceedings of the 11th CIOMS Round Table Conference, Geneva, Switzerland, 8-9 December 1977. Ed. Z. Bankowski, J.F. Dunne, Published by scrip World Pharmaceutical News London, 1978.
- 10. Pharmacovigilance: Working Groups WorkingGroup Period (some examples) Report/Year CIOMS I - International Reporting of Adverse Drug Reactions (1990) CIOMS II - International Reporting of Periodic Drug Safety Update Summaries(1992) CIOMS III - Guidelines for Preparing Core Clinical Safety Information on Drugs (1995) CIOMS IV 01/1995-07/1997 Benefit-risk balance for marketed drugs (1998) CIOMS V 04/1997-08/2000 Current Challenges in Pharmacovigilance: Pragmatic Approaches (1999) CIOMS WG on SMQs 05/2002- Development and Rational Use of Standardized MedDRA Queries (SMQs):Retrieving Adverse Drug Reactions with MedDRA (2004) CIOMS VI 03/2001-10/2004 Management of Safety Information from Clinical Trials (2005) CIOMS VII - Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials (2006) CIOMS VIII - Practical Aspects of Signal Detection in Pharmacovigilance (2010) CIOMS/WHO WG 11/2005-10/2010 Definition and Application of Terms for Vaccine Pharmacovigilance (2012) CIOMS IX - Practical Approaches to Risk Minimization for Medicinal Products (2014) CIOMS X 06/2011-07/2015 Evidence Synthesis and Meta-Analysis for Drug Safety (2016) CIOMS SMQ Implementation WG (05/2002)-2018/19 Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA (2016) CIOMS WG to Vaccine Safety 2013-2016 CIOMS Guide to Active Vaccine Safety Surveillance (2017) CIOMS Guide to Vaccine Safety Communication
- 11. Ongoing Working Groups WorkingGroup Objective Good Governance Practice for Research Institutions Propose standard guidelines promoting the minimal resources needed for researchers to work in accordance with the highest standards in research ethics and regulation. Recommended Standards of Education and Training for Health Professionals Participating in Medicines Development Propose standard guidelines promoting harmonization across all stakeholders working in and providing education in medicines development. Severe Cutaneous Adverse Reactions to Drugs – SCARs To establish a balanced, efficient, global perspective on SCAR detection, susceptibility factors, severity, outcome and probability through causality assessment tools, monitoring and management during the drug development and post-marketing phases. Working Group XIII – Real-World Data and Real- World Evidence in Regulatory Decision Making It would recommend an approach and prepare a consensus report promoting harmonization across global drug regulatory authorities and develop a POV on ethical considerations and challenges related to RWD and RWE Working Group XII – Benefit-Risk Balance for Medicinal Products THE WG will build on previous considerations established by CIOMS WG IV, incorporating the latest thinking in quantitative and qualitative approaches to the evaluation of benefit-risk (B-R), as well as assimilating visual presentations of benefits and risks to improve transparency and understanding amongst key stakeholders, including patients. MedDRA Labelling Groupings It is proposed that globally harmonized principles, points to consider, and pragmatic recommendations for development of MedDRA Labelling Groupings (MLGs) be developed by a Council for International Organizations of Medical Sciences (CIOMS) working group. Working Group XI – Patient Involvement (2018) It includes participants from patient organizations, industry, regulators, academia and the World Medical Association. These experts are working together to formulate pragmatic Points to Consider in patient involvement. The guidance will provide a comprehensive overview of present knowledge and existing initiatives, and will address a wide range of the remaining challenges and practice gaps. The optimal consideration of patient perspectives will support the safe and effective use of medicines, thereby helping to improve the health of individuals and the public.
- 12. Impact on ICHGuidelines Working Group ICH Guideline CIOMS WG I and II Reports (1990,1992) ICH-E2A (1994): Clinical Safety Data Management- Definitions and Standards for Expedited Reporting CIOMS IA (1992) ICH E2B: Clinical Safety Data Management – Data elements for transmission of ICSR CIOMS WGs II and III (1992, 1995) ICH-E2C (1996): Clinical Safety Data Management - PBRER CIOMS WG V (2001) ICH E2D (2003): Post-Approval Safety Management – Definitions and Standards for Expedited CIOMS WG VIII Report ICH – E2F (2010): DSUR
- 13. CIOMS Form CIOMS ReportingForm I Part of CIOMS PV 1st WG report (International Reporting of ADR; initial 1987, final 1990) Served as a minimum standard for reporting of ADR of licensed drugs Served as a template for upcoming national forms Accessible on CIOMS Homepage