Responding effectively to outbreaks of infectious diseases saves lives. Sharing knowledge, learning, and experience of outbreak response across geographies, diseases, and between researchers and policy makers is essential. Without collaboration, outbreaks risk spreading in size and scale. 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 highlights how they sometimes go beyond those covered in traditional research frameworks. 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
Dissemination of information on the safety and efficacy of pharmaceutical products, based on information received from the WHO's network of "drug information officers", bulletins and journals etc. 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
New pop-up Coronavirus Knowledge Hub, a single-access portal to information with a focus on addressing the unknowns during the coronavirus outbreak, launches on The Global Health Network. 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
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
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
See the latest CIOMS Newsletter here 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
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
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
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
Can't find what you're looking for? You can browse news items previously featured on our home page in our News Archive! Read more
This module from the Toolkit for research and development of paediatric antiretroviral drugs and formulations introduces the concepts of pharmacovigilance and adverse drug reactions, discusses the burden of adverse drug reactions for children and explains the importance of pharmacovigilance in the context of antiretroviral therapy.
Public mistrust of vaccines is heightening, fuelled by new communication environments such as social media. Using the recent case of the Dengvaxia vaccine, Heidi Larson explores public and political reactions ...
The problem of substandard and falsified (SF) medical products affects all countries but few regulatory authorities or pharmaceutical companies have policies of publicly releasing data. In order to fill the ...
pv-education.org is an interactive web portal developed to advance pharmacovigilance education at medical, pharmacy and nursing schools. Developed by The Netherlands Pharamcovigilance Centre - Lareb (WHO Collaborating Centre for Pharmacovigilance ...
Before social media The discovery that thalidomide had teratogenic effects some sixty years ago was a turning point in the history of medication safety. The catastrophe maimed at least 20,000 ...
Spontaneous reporting has been defined as: ‘An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organization (e.g. WHO, Regional Centre, Poison ...
Medicines are of vital importance in health systems, and access to quality-assured medicines is part of the basic right to health. Nevertheless, poor quality medical products, including medicines, vaccines and ...
This Podcast was recorded by the Mesh Team, based on an interview with Dr Heidi Larson from the London School of Hygiene and Tropical Medicine. In this 30-minute interview, Dr ...
Though recipients of medicines, input from patients has historically been limited within healthcare systems, and by extension health research. This has resulted in their experiences, views, and decisions regarding medicine ...
The Cochrane Adverse Effects Methods Group (CAEMG), part of the Cochrane Collaboration, aims to inform on and help develop best practice methods for producing high quality systematic reviews, in particular ...
The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if ...
Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness ...
A novel application utilising data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been developed by a Biomedical Informatics team at the Cincinnati Children’s ...
