CIOMS (1).pptx

This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.

1. CIOMS Sanjay Yadav M.Pharm (Pharmacology)

2. What is CIOMS ? C ouncil for I nternational O rganizations of M edical S ciences International Non-Governmental 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 represents a 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 . Mission 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)

4. 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 .

5. Interesting Facts about CIOMS The general assembly of UN adopted CIOMS principles of medical Ethics related to prisoners in 1983 . In 1986- The very 1 st 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 .

6. CIOMS collaborations

7. Contact Details Phone :  [phone] - Due to the COVID-19 situation we are often working from home. Please contact us by e-mail. Email :  [email protected]

8. Organization

9. Pharmacovigilance: Working Groups Working Group 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

10. Ongoing Working Groups Working Group 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.

11. Impact on ICH Guidelines 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

12. CIOMS Form CIOMS Reporting Form I Part of CIOMS PV 1 st 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

13. THANK YOU For your precious time