To celebrate the collaboration between The Global Health Network and the new MRC/NIHR Trials Methodology Research Partnership, the Global Health Methodology Research Member Hub is excited to announce a competition inviting staff working in trials in low and middle-income countries ... 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 NIHR Global Health Policy and Systems Research (Global HPSR) programme is partnering UK researchers with low and middle-income countries (LIMCs) to support research in global health policy and systems research. Funding opportunities are available between June 2019 and September ... Read more
This global pharmacovigilance event will be a fantastic opportunity for Professionals, Researchers, Students, and Patients interested in different areas and disciplines, of all aspects of ensuring safe and effective use of healthcare products to come together. 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
Regular updates on the Brighton collaboration's work, including its virtual institute ACADEMY 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
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 ...
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 ...
