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See the latest Council for International Organizations of Medical Sciences (CIOMS) quarterly newsletters here
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Subscribe for free to keep up to date with the latest news on safer use of medicines, pharmacovigilance practice, the activities of the WHO Programme and related topics |
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Newsletter disseminating information on the safety and efficacy of pharmaceutical products, produced in the form of résumés in English
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News Archive
The HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps create a shared understanding of intended scientific decisions through core recommendations for clear and reproducible RWE study protocols. Pilot testing plans are underway. Read more
Renewed partnership will broaden the scope of SPEAC to deliver world-leading vaccine safety guidance & support for CEPI’s mission to compress development of new vaccines against pathogens with pandemic potential to 100 days Read more
Recommendations include: creating a culture where PV is prioritised, engagement / empowerment of communities to report harms, systems / infrastructural development, & learning within / between countries Read more
A collection of videos from experts in the field of Data Monitoring Committees Read more
Open access paper reviewing changes in safety surveillance, recent scientific advances, & arguing how they need to be harnessed to enhance pharmacovigilance Read more
The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and ... Read more
The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and ... Read more
Supporting congenital anomaly surveillance - access upcoming & previous webinars on the Global Birth Defects hub website Read more
Supporting congenital anomaly surveillance - access upcoming & previous webinars on the Global Birth Defects hub website Read more
Bluprint developed through a step-wise consensus process to define the strategic priorities & objectives for vaccines safety for 2021 to 2023 & beyond Read more
Bluprint developed through a step-wise consensus process to define the strategic priorities & objectives for vaccines safety for 2021 to 2023 & beyond Read more
CIOMS has produced a living glossary (first published 2021), compiling definitions from its reports on various topics in the field of pharmacovigilance Read more
The best stories from the world of PV, covering new research & trends, exploring the most pressing issues in medicines safety today Read more
A new e-learning initiative to strengthen COVID-19 vaccine safety monitoring systems in African countries Read more
Implementation research (IR) is critical to ensuring the safe, effective and timely rollout of the RTS,S malaria vaccine using approaches that are adapted to varying local contexts. The Access and Delivery Partnership has helped to strengthen IR capacities in Ghana ... Read more
Updated information is being provided for people and healthcare professionals on the possible risk of extremely rare and unlikely to occur specific types of blood clots following vaccination with the COVID-19 Vaccine AstraZeneca, the Medicines and Healthcare products Regulatory Agency ... Read more
EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). Read more
EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. Read more
Find links to a wide variety of resources related to safety monitoring and pharmacovigilance during the COVID-19 pandemic Read more
WHO is in regular contact with the European Medicines Agency and regulators around the world for the latest information on COVID-19 vaccine safety. The WHO COVID-19 Subcommittee of the Global Advisory Committee on Vaccine Safety is carefully assessing the latest ... Read more
There is a reported increase in the use of the antiparasitic drug ivermectin for the prevention and treatment of COVID-19 by the public in African Union Member States. Read more
Based on the Nuffield Council on Bioethics report, this new course explores core ethical issues that arise during research in global health emergencies, and ... Read more
SPEAC has completed a second update of the COVID-19 clinical literature covering the period of August 8 through November 13th 2020. Read more
Those most susceptible to the worst outcomes of COVID-19 are the immunocompromised and with underlying comorbidities, posing a risk for drug-drug interactions (DDIs). See the interactions checker and free prescribing resources to aid the use of experimental agents in the ... Read more
Warnings on self-medication / stopping medicines; pharmacological considerations in older people; medication errors, interactions & ADRs; off-label use; supply management; misleading claims / fraud; & clinical research Read more
An article in Drug Safety highlights the role of pharmacovigilance in the pandemic situation, and more specifically, the role of the International Society of Pharmacovigilance (ISoP) during the current coronavirus 2019 (COVID-19) outbreak Read more
This webinar covered the importance of integrating clinical pharmacology and translational medicine principles in COVID-19 dosing strategy and study design with a demonstration of PKPD simulation tools available on covidpharmacology.com using recently completed analyses for ivermectin, chloroquine, and lopinavir/ritonavir Read more
IDDO’s Medicine Quality Research Group has developed a system for collating and curating global data on the quality of essential medical products and occurrence of substandard and falsified (SF) medical products in the lay press – the MQM Globe. Read more
If you are caring for patients with COVID-19, you may register for free at medsafetyscan.org and log in to use the program to enter patients' clinical risk factors and their medicines. The program quickly reports if any are on the ... Read more
The module was developed as part of the SCOPE Joint Action project to raise awareness levels of ADR reporting. You are requested to complete a short survey upon completion of the free e-learning. Read more
Six modules about Adverse Drug Reactions developed by NHS Education for Scotland and the Yellow Card Centre Scotland (Centre for Adverse Reactions to Drugs Scotland); their incidence & public health implications, the different classifications of ADRs & drug allergies, how ... Read more
The International Society of Pharmacovigilance’s (ISoP’s) held a Mid-Year Symposium and Training Course in Nairobi, Kenya brining together nearly 100 ISoP members from across Africa and beyond, including from government/regulatory bodies, the pharmaceutical industry and academia. The event concluded with ... Read more
We have a growing list of articles detailing personal experiences of post-graduate study or working in pharmacovigilance. This is intended to inspire others who may be considering their own PV journey. Would you like to be featured? We'd love to ... Read more
The Global Malaria Programme is currently designing an international external quality assessment (EQA) to promote quality improvement in nucleic acid test (NAT) performance for the detection of Plasmodium parasites and are calling for laboratories who are conducting NAT to complete ... Read more
FDA is developing four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory ... Read more
The EMA has published a Q&A document for public consultation until 31 July 2019. This supplements the CHMP Data Monitoring Committee Guideline, clarifying the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and ... Read more
This course which is based at the Wellcome Trust Centre for Global Health Research takes a multidisciplinary approach to how pharmacy and global health are related, with an emphasis on addressing health inequities, and including relevant pharmacovigilance methods. Read more
PAVIA and PROFORMA are two large, coordinated, African pharmacovigilance consortia that are part of the EDCTP2 programme supported by the European Union’s Horizon 2020 research and innovation programme Read more
Overview of presentations and key points discussed during the seventh meeting of the Global Vaccine Safety Initiative (GVSI), Santiago, Chile, 8–9 October 2018 Read more
LIFE is a 3D simulation training app for smartphones that teaches healthcare workers how to manage medical emergencies using game-like training techniques to reinforce the key steps that need to be performed in order to save lives. Read more
Compilation of Medication Safety Minutes from St James Hospital, Dublin, Ireland - bite sized information nuggets each highlighting a medication safety issue of relevance to prescribers Read more
February 11, 2019 - The Birth Defect Surveillance Group, part of ZikaPLAN’s Work Package 8 (Disease Burden and Risk Assessment), announces the launch of the Global Birth Defects website. Read more
Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. The Global Benchmarking Tool (GBT) represents the primary means by which the WHO objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on ... Read more
Epidemiological research has become an important tool in assessing vaccine protection. This course will provide in-depth training on current methods used in the evaluation of vaccine efficiency, safety and policy, aiming to address immunisation issues in high, middle and low ... Read more
The new WHO PV Toolkit comprises resources and information for the practice of pharmacovigilance, with a special focus on low- and middle-income countries. Read more
A webinar on regulatory filing & pharmacovigilance recorded by The Global Accelerator for Paediatric Formulations (GAP-f), which aims to promote a faster, more efficient and more focused approach to paediatric formulation development Read more
FDA is developing four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory ... Read more
The EMA has published a Q&A document for public consultation until 31 July 2019. This supplements the CHMP Data Monitoring Committee Guideline, clarifying the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and ... Read more
Lots of great content in the latest CIOMS newsletter, including a new Working Group topic: Severe Cutaneous Adverse Reactions (SCARs) Read more
A new ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote scientific independence and transparency throughout the research process. Read more
IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes. A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Adverse Events Terminology Working Group to include the proposed third edition of Document ... Read more
A new framework for a core curriculum for university teaching of pharmacovigilance (PV) has been published, describing five key aspects that focus on clinical practice: the importance of PV in the context of pharmacotherapy and preventing, recognizing, managing and reporting ... Read more
The new African Medicines Agency (AMA) will ensure coordination and strengthening of continental initiatives to harmonise medical products regulation, provide guidance and technical support to improve access to quality, safe and efficacious medical products and health technologies. See https://t.co/y2e8HWEMPu Read more
Regular updates on the Brighton collaboration's work, including its virtual institute ACADEMY Read more
Following disclosure of new data on Dengvaxia® WHO initiated a process engaging independent external experts to review the data in detail, and reconvened the SAGE working group on dengue vaccines. This process has led to revised recommendations from SAGE on ... Read more
First-ever dedicated academic and programmatic conference on Medicine Quality and Public Health, 23-28 September 2018, at Keble College in Oxford, UK Read more
The UK Teratology Information Service and Newcastle upon Tyne Hospitals NHS Foundation Trust are pleased to invite you to the first UK human teratogens education course (September 4-6, 2018) and 3rd International Joint Meeting of the European Network of Teratology ... Read more
A piece in the New York Times refers to a recent Science paper about differing views on human challenge trials, reflecting on phase 1 trials in healthy volunteers and malaria human challenge trials Read more
The University of Cape Town Medicines Information Centre has release its latest freely available booklet with useful, simple algorithms on how to treat patients on ARVs and/or TB treatment, who develop adverse drug reactions – including rash, kidney injury and ... Read more
The 4th issue of WHO Drug Information introduces a collaborative project between WHO, BMGF and regulatory agencies to develop smart safety surveillance (3-S), starting with selected priority medicines/vaccines to be introduced in LMICs in the next few years, throughout their ... Read more
The collaboration establishes the safety of any drug exposure, such as antiretrovirals for HIV, malaria medicines, and treatment for schistosomiasis, visceral leishmaniasis and other parasitic diseases. A standard protocol for collection of data on congenital abnormalities related to possible drug ... Read more
A new modular course - short individual lessons with transcripts and a quiz at the end to check if the student has understood the content. Read more
A new health worker training model in Nigeria, adapted from a global research and capacity-building initiative, has been shown to increase reporting of adverse drug reactions in a country treating the largest population of people living with HIV/AIDS, tuberculosis and ... Read more
See ISoP for training at annual meetings, mid-year courses, PV curriculum and more Read more
An update to the Erice 1996 declaration and Erice 2006 Manifesto Read more
