Global Guidance Dr Lembi bit Rägo Rägo Secretary-General Council for on patient involvement International Organizations of Medical Sciences (CIOMS) Joint PCWP-HCPWP Meeting, EMA, Amsterdam, 4 March 2020 Geneva, Switzerland ragol@cioms.ch
Content What is CIOMS ? Organization, links with other international organizations Areas of work and Working Groups CIOMS Working Group XI: Patient Involvement in Drug Development and Safe Use Background and scope WG processes, progress Draft content Examples of selected chapters Plans for future Conclusions EMA 4 March 2020 2
What is CIOMS?
Acronym & Logo C ouncil for I nternational O rganizations of M edical S ciences Founded in 1949 by WHO and UNESCO In official relations with WHO and UNESCO associated partner ICH Observer since 2016 Mis ission ion Statem tement ent CIOMS mission is to advance public health through guidance on health research including ethics, medical product development and safety EMA 4 March 2020 4
CIOMS in short Organization located in Geneva : A. International B. Nongovernmental C. Not-for-Profit Forum for discussion and neutral platform to elaborate new ideas in medical product development, pharmacovigilance and research ethics (bioethics) ... for WHO, health authorities, academic organizations, pharmaceutical industry and other concerned stakeholders CIOMS: an umbrella organization of medical science organizations EMA 4 March 2020 5
Programs, Activities Product • Since 1967; 1. CIOMS • 1986 first • Trends and Pharmaco Bioethics Develop- Round Table PV Working Prospects in Drug -vigilance ment Conference “Biomedical Group, 13 Research and Science and the more Development, dilemma of Human working Proceedings of the 11 th CIOMS Round Experimentation”) group reports Issuance of significant until today Table Conference, guidelines; latest Geneva, • Several revision 2016 Switzerland, 8-9 ICH December 1977. • Focus on "low and Guidelines Ed. Z. Bankowski, middle income are based on J.F. Dunne, countries“; translated results of published by Scrip into many languages CIOMS World including Chinese, Working Pharmaceutical Spanish, Japanese, Groups News, London, Russian 1978. Core of activities: Technical Working Groups Run-time: Mostly 2-4 years, or even more than 10 years (SMQs) Impact: Legally not binding, yet significant influence on healthcare community (including decision makers and other organizations with impact); can also be transformed to be legally binding when embodied in regional/national legislation 6 EMA 4 March 20202
CIOMS communication Website: https://cioms.ch EMA 4 March 2020 7
Members, links with other international organizations
CIOMS membership EMA 4 March 2020 9 9
Recent new members (2018) New international member of CIOMS The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine ( IFAPP ) New national member of CIOMS Bangladesh Medical Research Council EMA 4 March 2020 10
CIOMS and ICH (2) CIOMS is ICH Observer since 2016 MEMBERS OBSERVERS Foun undin ing g Reg egula lato tory y Membe bers S tan andin ing Obse servers vers Reg egio iona nal l Harmon onisa isatio tion • EC, Europe • IFPMA Init itia iative ives s (RHIs) Is) • FDA, US • WHO • APEC • MHLW/PMDA, Japan • ASEAN Legisl islati tive ve or Admin inist istrati rative ve • EAC Foundin ing Indust stry ry Members Auth thorit itie ies • GHC • EFPIA • CDSCO, India • PANDRH • JPMA • CECMED, Cuba • SADC • PhRMA • COFEPRIS, Mexico Standin ing Regula lato tory ry Members rs • INVIMA, Colombia Inte tern rnati tional l Pharm rmace ceutica ical l • Health Canada, Canada • MCC, South Africa Industry stry Organisa isatio ion • Swissmedic, Switzerland • National Center, Kazakhstan • APIC • Roszdravnadzor, Russia Regula lato tory ry Members rs Inte tern rnati tional l Organisa isati tion • TFDA, Chinese Taipei • ANVISA, Brazil regula late ted • TGA, Australia • CFDA, China or affe fecte cted by ICH Guid ideli line(s) (s) • HSA, Singapore • Bill & Melinda Gates Foundation • MFDS, Republic of Korea • CIOMS Industry stry Members rs • EDQM • BIO • IPEC • IGBA • PIC/S • WSMI • USP 11 EMA 4 March 2020
CIOMS impact on ICH* Guidelines CIOMS pharmacovigilance guidelines served as a basis for several ICH guidelines. Some examples: Work rking ing Group oup ICH Guideline ICH-E2A (1994): Clinical Safety Data Management – CIOMS WG I und II Reports (1990, 1992) Definitions and Standards for Expedited Reporting ICH E2B: Clinical Safety Data Management – CIOMS IA Report (1992) Data elements for transmission of individual case safety reports ICH-E2C (1996): Clinical Safety Data Management – CIOMS WGs II und III Reports (1992, 1995) Periodic Benefit-Risk Evaluation Reports (PBRER) ICH-E2D (2003): Post-Approval Safety Management – CIOMS WG V Report (2001) Definitions and Standards for Expedited ICH-E2F (2010): Development Safety Update Reports CIOMS WG VIII Report (2006) *ICH - The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use EMA 4 March 2020 12
Cooperation with ICH Extract from MedDRA MC to ICH Assembly Med = Medical D = Dictionary for November 2019, Singapore R = Regulatory A = Activities 13 EMA 4 March 2020
Areas of Work and Working Groups
Pharmacovigilance: Working Groups Working ng Group Period (some examples es) 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) Development and Rational Use of Standardized MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions CIOMS WG on 05/2002 - with MedDRA (2004) SMQs CIOMS VI 03/2001 -10/2004 Management of Safety Information from Clinical Trials (2005) Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic Safety CIOMS VII - 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 Minimisation for Medicinal Products (2014) CIOMS X 06/2011 – 07/2015 Evidence Synthesis and Meta-Analysis for Drug Safety (2016) CIOMS SMQ Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions (05/2002) – 2019 Implementation WG with MedDRA (2016) CIOMS WG to CIOMS Guide to Active Vaccine Safety Surveillance (2017) 2013 -2016 Vaccine Safety CIOMS Guide to Vaccine Safety Communication (2018) CIOMS WG on DILI 2017 – ongoing Overview of CIOMS activities, including Working Group XI 15
Pharmacovigilance: Recent Safety Publications https://cioms.ch/shop/product-category/recently-published/ Shanghai, December 2019 16
CIOMS reaches out in many languages Geneva, December 2019I EMA 4 March 2020 17 17
E-training course https://cioms.blendleren.nl/Navigating-the-2016-CIOMS-International-Ethical-Guidelines EMA 4 March 2020 18
Ongoing Working Groups today Five WGs ongoing: CIOMS Working Group on Drug Induced Liver Injury (DILI) (started 2017) • CIOMS Working Group on Clinical Research in Resource Limited Settings • (November 2017) CIOMS Working Group on Patient Involvement in Development and Safe Use of • Medicines (April 2018) – WG XI CIOMS Expert Working Group on MedDRA Labeling Groupings (MLGs) (April • 2019) • Revision of CIOMS IV : Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals (September 2019) – WG XII New WGs 2020: CIOMS Working Group on Real World Evidence and Real World Data in • Regulatory Decision (March 2020) – WG XIII CIOMS Working Group on Severe Cutaneous Adverse Reactions (SCARS) – Q3 • 2020 19 EMA 4 March 2020
CIOMS Working Group on Patient Involvement in Development and Safe Use of Medicines (April 2018) – WG XI
When CIOMS WG started a lot was already ongoing … Source: Marc M. Boutin , DIA San Diego June 2019 EMA 4 March 2020 21
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