The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants. The safety and well-being of trial participants should always be the utmost priority when designing early ... Read more
The conference programme will address the latest trends in pharmacovigilance and how they can be harnessed for patient benefit in the 21st century and beyond. 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
EMA will launch a new and improved version of EudraVigilance on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions. The Agency is delivering training courses on the enhanced EudraVigilance system to support national competent authorities ... Read more
WHO have launched a new global programme which aims to reduce the harm caused by avoidable medication errors. Read more
The Global Health Network is celebrating a major milestone in it’s quest to enable life-saving evidence to be gathered in the world’s poorest countries. This is all about a digital platform for medical researchers around the world that is changing ... Read more
We asked you for your views on this site and what you wanted to see - here are the results!! Read more
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) unites regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of the drug registration process. Click here to read more about ICH. Read more
The WHO has announced the publication of their latest training manual aimed at health professionals and policy makers working in the context of an emergency situation. Read more
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 ...
See http://www.buildingteratovigilance.co.za/ for more information and registration
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 ...
