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 pharmacovigilance grants and WHO internships Read more
Significant revisions as regards patient registries, social media & electronic devices, research networks, definition and validation of drug exposure, outcomes and covariates, methods to address bias & a new chapter on methods for pharmacovigilance impact research 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
The International Society of Pharmacovigilance will hold its 18th annual meeting from 11-14 November 2018 in Geneva, Switzerland. The conference aims to to optimise pharmacovigilance, creating greater efficiency and clarity of reporting, thus enable analysis of the latest information to ... 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
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 International Society of Pharmacovigilance will hold its 18th annual meeting from 11-14 November 2018 in Geneva, Switzerland. The conference aims to to optimise pharmacovigilance, creating greater efficiency and clarity of reporting, thus enable analysis of the latest information to ... 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
While welcoming the increased scope of the 2017 revised European Medicines Agency (EMA) guidance on first-in-human and early clinical trials, there is debate about whether the approach is too conservative and may impact drug development negatively without offering much benefit ... Read more
Keep up to date with the latest news on safer use of medicines, pharmacovigilance practice, the activities of the WHO Programme and related topics Read more
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 ...
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 contracted ...
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 ...
In clinical drug trials, researchers have an obligation to safeguard participants against harms which may be related to the interventional drug, and to ensure the benefit-to-harms ratio remains favourable for ...
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 ...
