Lembit Rägo’s Post

We are pleased to announce that the draft report of the CIOMS Working Group on Severe Cutaneous Adverse Reactions (SCAR) is now available for comment on the Working Group webpage at: https://lnkd.in/eyTvAHb4 The report includes the following chapters: Chapter 1- What are Severe Cutaneous Adverse Reactions?, Chapter 2- Identification and Diagnosis of SCAR Cases, Chapter 3 –Case Management in Clinical Care, Chapter 4 – Biomarkers for SCAR, Chapter 5 – Causality Assessment for SCAR in Pre- and Postauthorization Surveillance, Chapter 6 – Pre-authorization Safety Data Collection and Analysis, Chapter 7 – Postauthorization Safety Data Collection and Assessment, and Chapter 8 – Risk Minimization The deadline for comments is Friday, June 7th 2024. Please disseminate this information to your networks.

Year 2024 is the 75th anniversary of CIOMS! Our March 2024 Newsletter is now available here https://lnkd.in/dmGxsapT In the first quarter of 2024, four new CIOMS publications/translations have been issued including the CIOMS Expert Working Group report on MedDRA Labeling Grouping (MLG) proposing standardised principles for grouping adverse reaction terms in product safety labels. Since the year started, four CIOMS Working Group (WG) meetings have been held. We are also delighted to announce the winner of the 2023 CIOMS award for the scientific paper authored by a student. Finally you will find our roundup of news related to CIOMS areas of work.

The CIOMS new report Introduction to MedDRA Labeling Grouping (MLG): A standardized approach to grouping adverse reactions in product safety labels (2024) is now available https://lnkd.in/dpzgNCWc The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). Given its long-standing contributions (2002-2016) towards the design and production of Standardised MedDRA Queries (see also Development and Rational Use of SMQs, CIOMS, 2016), it is not surprising that CIOMS convened an Expert Working Group with multiple major stakeholders, to produce a consensus document on principles and points to consider in the development of MLGs.

The 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans (prepared in collaboration with WHO) provide internationally vetted ethical principles and detailed commentary on how these principles should be applied. The Polish edition of this CIOMS publication was produced with the support of the Jagiellonian University Publishing House. The guidelines are now available in 11 languages: English (original), Arabic, Chinese, French, Japanese, Korean, Polish, Portuguese, Russian, Spanish, and Ukrainian #clinicaltrials #researchethics #clinicalresearch #ethicalresearch https://lnkd.in/dXXDbMgz

We are pleased to announce that the CIOMS Cumulative Glossary with a Focus on Pharmacovigilance (Version 2.1) is now available also in Korean language: https://lnkd.in/dsspygsp We gratefully acknowledge SELTA SQUARE for making this translation available in Korean.

The CIOMS Glossary of ICH terms and definitions Version 5 is now available for download. It newly includes definitions from the following ICH guidelines: Q14 Analytical Procedure Development, Q2(R2) Validation of Analytical Procedures and Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The CIOMS ICH Glossary combines the definitions from across the current, publicly available guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). It can accessed via the ICH webpage or this link: https://lnkd.in/dMFY3GpQ

The CIOMS December 2023 Newsletter is now available. The highlight in the 4th quarter of 2023 was the launch of the CIOMS International Guidelines on Good Governance Practice for Research Institutions. The CIOMS WG XI report on Patient involvement in the development, regulation and safe use of medicines has become available in Japanese. The newsletter also includes updates on CIOMS WGs, regulatory developments related to the CIOMS areas of work, and list the most popular downloads of CIOMS publications, all freely available on our website. We wish you a healthy and peaceful year 2024. https://lnkd.in/e_JZXx4g #regulatoryaffairs #regulation #clinicalresearch #clinicaltrials #researchethics #medicines #pharmacovigilance #productdevelopment

Just to let you know that the NEW CIOMS report "International guidelines on good governance practice for research institutions" (2023) is now available at https://lnkd.in/ei34snFa. Since the 1960s numerous ethical, professional and regulatory guiding documents have been adopted to facilitate the increasingly complex research activities conducted with human participants globally. Many of these guidelines focus on individual researchers’ responsibilities to protect research participants while conducting good quality scientific studies. In practice, however, it is rarely assessed to what extent researchers are given the necessary resources for this purpose at their institutions. This report reviews the existing international standards and best practices in the field of health-related research, and offers research institutions detailed and specific guidance on how to implement them. #clinicaltrials #clinicalresearch #researchethics #researchanddevelopment #researchexcellence #ethics #goodgovernance

I am happy to report that last week (2-3 November) we launched in Geneva CIOMS WG XV: Harnessing the potential of pharmacoepidemiology for public health. Pharmacoepidemiology aims to appraise and understand the use and effects — both beneficial and adverse — of medicines in real-world settings. As such it can be considered a bridge science, linking clinical pharmacology, epidemiology, public health and the social sciences. The concept note for this new WG is posted on its website at: https://lnkd.in/eUyv-SMv All full WG meeting minutes will be web posted there as well.

I am going to speak about CIOMS WG XIII - RWD/RWE in Regulatory Decision Making - on Thursday this week at the World Vaccine Congress Europe taking place on 16-19 October 2023 in Barcelona! #WVCEU #vaccinedevelopment #rwe #rwd #regulation