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December 2023 | Newsletter# 44

Just published:
International guidelines on good governance practice for research
institutions | CIOMS patient involvement guidance in Japanese
CIOMS Working Group (WG) meetings — in-person:
18th (first face-to-face): Real-World Data and Real-World Evidence
1st: Pharmacoepidemiology for public health
Virtual meetings
IMDRF 2023 – International Medical Device Regulators Forum
World Vaccine Congress Europe
International Council for Harmonisation (ICH) Assembly meeting
European Pharmacovigilance Congress (EUPV 2023)
28th Annual Swiss Symposium in Pharmaceutical Medicine
WHO Global Clinical Trials Forum
CRGo World Conference 2023
Webinars
U.S. FDA: Benefit-risk assessment guidance
WHO: Regulating artificial intelligence
Focus on: Regulatory harmonization and relianceWHO-listed authorities (WLA)SAHPRA: South African reliance guideline
CIOMS cited | Book chapter on CIOMS research guidelines

Find us on the web
Ongoing CIOMS Working Groups
Top ten CIOMS publications

December 2023 | Newsletter # 44

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December 2023 | Newsletter# 44(Above) The Working Group, at its final
meeting in August/September 2023

Scientific research is essential for the health and well-being of people aroundthe world, and is becoming ever more important for humanity to face current
and future health emergencies. But scientific studies can only be effective ifthey are done in compliance with existing high ethical and scientificstandards.
Many professional and regulatory guidelines have been adopted in recent
decades, mostly focusing on individual researchers’ responsibilities. But towhat extent do they have the required resources at their workplace? The new
CIOMS guidelines describe the existing standards and best practices in thefield of health-related research, and offer detailed and specific guidance on
how to implement them at institutional level.
International guidelines on good governance practice for research
institutions. CIOMS Working Group report. Geneva, Switzerland: Council forInternational Organizations of Medical Sciences (CIOMS), 2023. Freely
available at: https://doi.org/10.56759/hslk3269(Above) The new Working Group report complements the2016 CIOMS International ethical guidelines on health-related
research involving humans; which are widely used as astandard for good quality, ethical research.

Images by Bonnie Henderson & ID12019 from Pixabay(Left) Research is not only done at dedicated centres, butalso at institutions that do not consider research as theirprimary mission, such as universities or hospitals. These mayfind the guidelines especially useful.

The CIOMS Working Group XI report on Patient involvement in thedevelopment, regulation and safe use of medicines is now available inJapanese as a pre-print version on the website of the journal Rinsho Hyoka(Clinical Evaluation). The final print version, with minor corrections andformat changes, will be posted at the same address.
Patients and consumers in Japan can participate in the approval of
medicines. The translation makes the CIOMS guidance accessible to them intheir own language.

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December 2023 | Newsletter# 44

Fourth quarter of 2023

This group published its draft report for comment
in June 2023. The draft generated considerable
interest, attracting more than 900 comments andquestions from commentators all over the world.
At their 18th meeting—their first to be held in
person—the group members discussed the input
received. Their decisions will be taken forward by
the group’s Editorial Committee in finalizing thereport. The full meeting minutes are available on
the Working Group’s webpage.

Surveillance for adverse effects of medical
products has become a very complex task: scienceand technologies are evolving, expectations ofregulators, health care funders and patients must
be met, and global public health is becoming
increasingly fragile due to environmental andman-made challenges. The CIOMS Working GroupXV will look into the best ways to apply current
and new approaches to pharmacovigilance.

Fourth quarter of 2023

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December 2023 | Newsletter# 44

At the invitation of the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy
Trade Association (DITTA), CIOMS Secretary-General Lembit Rägo attended the24th session of the International Medical Device Regulators Forum (IMDRF). At a side
event he introduced the DITTA leadership to the work of CIOMS and answeredquestions.
Conference website

This event is the largest, most established meeting
dedicated to vaccines, with a record 2000+ participantsfrom science, governments and industry attending in 2023.
CIOMS Secretary-General Lembit Rägo introduced the draft
report of the CIOMS Working Group XIII on Real-world data
and real-world evidence in regulatory decision-making.
Congress website
Images from Congress website

CIOMS is an observer in the International Council for Harmonisation (ICH) and was
represented at the Assembly meeting by Secretary-General Lembit Rägo. Delegateswere updated on new developments, including the signature of a Memorandum ofUnderstanding with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
ICH Press release, 8 November 2023 | ICH Meetings > Assembly (agenda, minutes)
Note: Since 2022 CIOMS maintains a Glossary of ICH terms
and definitions from across ICH guidelines on its website.

CIOMS was again represented prominently in this year’s
European Pharmacovigilance Congress (EUPV 2023). CIOMS
President Hervé Le Louët introduced the virtual session on‘Risk Communication’ while CIOMS Secretary General Lembit
Rägo chaired the opening session on ‘Evolving
Pharmacovigilance Strategies’ in Milan.
Congress website

This event focused on Optimising Patient Engagement andEnsuring Access to Treatment. CIOMS Secretary-General
Lembit Rägo presented the CIOMS Working Group XI reporton Patient involvement.
Meeting website

December 2023 | Newsletter # 44

Image courtesy of event organisers

Images from meeting website

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December 2023 | Newsletter# 44This event served to develop a joint vision and exchange
experiences on strengthening clinical research capabilities in linewith the World Health Assembly resolution WHA75.8. Participants
called for several priority actions to strengthen the clinical trials
ecosystem.
In July 2023 WHO had called for comments on a draft guidance
document on strengthening clinical trials. The draft is partly based on
the 2021 CIOMS consensus report on Clinical research in resourcelimited settings (2021) and the CIOMS International ethical guidelines
for health-related research involving humans (2016). Elements fromthe new CIOMS International guidelines on good governance practicefor research institutions are also to be included.
(Right) Among the participants were Dominique Sprumont, Andreas
Reis, Roli Mathur and Nathalie Strub-Wourgaft, all of whom
contributed to one or more of the above-mentioned CIOMS guidelines.

CIOMS Working Group chair Dominique Sprumont attended the ClinicalResearch Governance (CRGo) World Conference & International Clinical
Trial Center Network Symposium 2023. He took the occasion to announce
the release of the CIOMS International guidelines on good governancepractice for research institutions (see page 1). The conference marked the25th anniversary of the University of Hong Kong’s Clinical Trials Center,
which is directed by CIOMS Working Group member Henri Yau.
Conference website

CIOMS Working Group XII members Hong Yang and Leo Plouffe presented
the group’s draft report on Benefit-Risk Balance for Medicinal Products atthe third quarterly scientific webinar of the American Statistical
Association (ASA)’s Safety Working Group. The discussion focused on how
to align and improve the ASA Safety group’s deliverables on benefit-risk
assessment planning in line with the CIOMS work.

See also:
https://cioms.ch/webinars/

December 2023 | Newsletter # 44

Webpage | Recording

This webinar served to introduce a new book about research ethics intimes of pandemics. In Part 2, CIOMS Secretary-General Lembit Rägo
presented Chapter 10, which gives an overview of the history andactivities of CIOMS in relation to bioethics (for details see page 7).
Webinar flyer | Part 1 recording | Part 2 recording
Kurihara C, Greco D, Dhai A (editors). Ethical Innovation for Global
Health. Springer Nature Singapore Pte Ltd. 2023.
doi:10.1007/978-981-99-6163-4 (not open-access)5

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December 2023 | Newsletter# 44

Based on an image by Nicolás from Pixabay

U.S. Food and Drug Administration

The U.S. FDA has released its final guideline on
Benefit-Risk Assessment for New Drug and
Biological Products. The guidance discusses how
patient experience data, sponsors’ development
programmes and information presented in themarketing application may be used to inform thebenefit-risk assessment, and also considers factorsthat inform decision-making in the postmarket
setting.
Benefit-Risk Assessment for New Drug and
Biological Products. Guidance for Industry.
October 2023.

World Health Organization

WHO has published a new guidance
document on how to regulate
artificial intelligence (AI) to makeuse of its potential while mitigating
its risks. The publication outlines
the main principles that national orregional governmental authorities
can use as a basis to develop new guidelines or toadapt existing ones.
AI can help to strengthen clinical trials, improve
diagnosis, treatment, self-care and person-centredcare, and can supplement the knowledge, skills andcompetencies of health care professionals. However, it also presents serious risks of unethical datacollection, cybersecurity threats and amplifying
biases or misinformation.
WHO. Regulatory considerations on artificial
intelligence for health. 2023.
Medscape. WHO offers recommendations for AI
guidelines in healthcare. 14 November 2023.

December 2023 | Newsletter # 44

Health regulatory authorities are increasingly
looking to rely on each other’s work so as to make
optimal use of limited resources. WHO hasdeveloped a framework to designate so-called
WHO-listed authorities (WLA), identifying them as
operating at an advanced level of performance,
meaning that they meet WHO standards and otherinternationally recognized standards and practices.
The first three WLAs have now been publicly listedon the WHO website. They are the regulatory authorities of the Republic of Korea (for medicines andvaccines); Singapore (medicines); and Switzerland(medicines and vaccines). This supplements WHO’slist of transitional WLAs of 54 bodies formerly known
as ‘stringent regulatory authorities’ in the moreprocurement-oriented concept that was used before
the WLA framework came into being.
Note: The WLA technical advisory group (TAG-WLA)
provides independent, strategic, and technical advice to
WHO regarding this initiative. CIOMS Secretary-General
Lembit Rägo is one of its 14 members.

South African Health Products Regulatory Agency

The South African regulatory authority has released
its draft reliance guideline for review of marketing
authorization applications and variations. Threedifferent pathways are proposed for relying onother authorities’ assessments. The draft lists
examples of recognized regulatory authorities(RRAs), together with the documents that would
comprise a complete assessment for each.
SAHPRA is currently negotiating recognition
agreements with RRAs, and will publish aframework for the practical implementation ofeach agreement once it is concluded.
SAHPRA. Reliance guideline. Draft, 2 November
2023.

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December 2023 | Newsletter# 44

Boytchev H. Concerns over informed consent for pregnant women in Pfizer's RSV vaccine trial.
BMJ. 2023;383:2620. Published 2023 Nov 15. doi: 10.1136/bmj.p2620
Elhawary MA, Ogar CK, Tarapués M, et al. The Role of ISoP in the Advancement of Pharmacovigilance in Lowand Middle-Income Countries (LMICs) [online ahead of print, 2023 Oct 24].
Drug Saf. 2023;10.1007/s40264-023-01363-8. doi:10.1007/s40264-023-01363-8
Ho A, Joolaee S, McDonald M, et al. Navigating Informed Consent Requirements and Expectations in Cluster
Randomized Trials: Research Ethics Board Members' and Researchers' Views.
Ethics Hum Res. 2023;45(6):31-45. doi:10.1002/eahr.500189
Katzer M, Salloch S, Schindler C, Mertz M. Ethical Requirements for Human Challenge Studies: A Systematic
Review of Reasons [published online ahead of print, 2023 Sep 16].
Clin Pharmacol Ther. 2023;10.1002/cpt.3054. doi:10.1002/cpt.3054
Kerpel-Fronius S, Kurihara C, Crawley FP, et al. The ethical responsibility to continue investigational
treatments of research participants in situation of armed conflicts, economic sanctions or natural
catastrophes. Front Med (Lausanne). 2022;9:950409. Published 2022 Aug 9.
doi:10.3389/fmed.2022.950409
Maxwell L, Shreedhar P, Dauga D, et al. FAIR, ethical, and coordinated data sharing for COVID-19 response: ascoping review and cross-sectional survey of COVID-19 data sharing platforms and registries.
Lancet Digit Health. 2023;5(10):e712-e736. doi:10.1016/S2589-7500(23)00129-2
Seaneke SK, Darko DM, Nkansah E, et al. First results from the lessons learnt from the deployment of the Med
Safety App for reporting adverse drug reactions in Ghana. Digit Health. 2023;9:20552076231211276.
doi: 10.1177/20552076231211276
Smit JR, Mostert M, van der Graaf R, Grobbee DE, van Delden JJM. Specific measures for data-intensive healthresearch without consent: a systematic review of soft law instruments and academic literature [online
ahead of print, 2023 Oct 17]. Eur J Hum Genet. 2023;10.1038/s41431-023-01471-0. doi: 10.1038/s41431023-01471-0
Sulaieva ON, Artamonova O, Dudin O, et al. Ethical navigation of biobanking establishment in Ukraine:
learning from the experience of developing countries. J Med Ethics. 2023;jme-2023-109129.
doi: 10.1136/jme-2023-109129
Vemula GK, Badale P, Mavrogenis P, et al. A Risk-Based Approach for Safety Case Follow-up of Adverse Event
Reports in Pharmacovigilance [online ahead of print, 2023 Nov 3]. Adv Ther. 2023;10.1007/s12325-02302699-4. doi: 10.1007/s12325-023-02699-4

Rägo L, Zweygarth M. CIOMS Research Guidelines: Considering the Needs ofDeveloping Countries. Chapter 10. In: C. Kurihara et al. (eds.). EthicalInnovation for Global Health. Springer Nature Singapore Pte Ltd. 2023.
https://doi.org/10.1007/978-981-99-6163-4_10 (not open-access)This chapter gives an overview of the history and activities of the Council forInternational Organizations of Medical Sciences (CIOMS) in the areas of research
ethics, medicines development and medicines safety (pharmacovigilance). Three
specific CIOMS guidelines are then briefly discussed: The 2016 CIOMS/WHO
International ethical guidelines on health-related research involving humans; the2021 CIOMS Working Group report on Clinical research in resource-limited settings;
and the 2022 report of the CIOMS Working Group XI on Patient involvement in thedevelopment, regulation and safe use of medicines.

December 2023 | Newsletter # 44

Introductory webinar:see page 2

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December 2023 | Newsletter# 44

1 September–17 December 2023

29 445
visitors from

188
countries

16 896
subscribers

Meeting minutes are posted on the groups’ webpages.
 Just completed: Good Governance Practice for Research Institutions
 Artificial Intelligence in Pharmacovigilance (WG XIV) Educational standards for health professionals participating in med’s development
 Severe Cutaneous Adverse Reactions to Drugs (SCARs)
 Real-World Data and Real-World Evidence in Regulatory Decision Making (WG XIII) Benefit-Risk Balance for Medicinal Products (WG XII) MedDRA Labelling Groupings
 Just started: Pharmacoepidemiology for public health (WG XV)

1 September–17 December 2023
2023
2023
2023
2016
2022
2005
2010
2021
2020
1999

Glossary of ICH terms and definitions (Version 4) 841
International guidelines on good governance practice for research institutions 779
CIOMS Cumulative glossary, with a focus on pharmacovigilance (Version 2.1)
 520
International ethical guidelines for health-related research involving humans*
 285
Patient involvement (Working Group XI) ** 242Management of Safety Information from Clinical Trials*** 215
Practical Aspects of Signal Detection in Pharmacovigilance 153Clinical research in resource-limited settings
 141Drug-Induced Liver Injury (DILI) 135
Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use 118*Also available in: Arabic, Chinese, French, Japanese, Korean, Portuguese, Russian, Spanish, Ukrainian** Also available in Japanese, see page 7 — *** Also available in Chinese

Discover all CIOMS publications

Dr Lembit Rägo
Ms Sue Le Roux
Ms Sanna Hill
Ms Catherine Bates

1 Route des Morillons, 1218 , Le Grand-Saconnex (Geneva), Switzerland
Postal address: Case postale 2100, CH-1211 Geneva 2
CIOMS is an international non-profit association under Swiss law.
Registration number: CHE-270.896.260

Ms Monika Zweygarth
info@cioms.ch

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