There are currently over 500.000 types of Medical Devices and in vitro diagnostic medical devices (IVDs) on the EU market [1]. Surgical techniques and Medical Devices may seem to...
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and...
Early Clinical Development refers generally to the first studies of a medicine in humans – typically known as Phase I and Phase II trials. Studies in early clinical development...
Non-clinical toxicity studies investigate the safety profile of a medicine. Candidate compounds must undergo many different toxicity studies before they are first administered in clinical trials or receive marketing...
Risk communication is a two-way exchange of information on the risks and benefits of a medicine. Patients, companies, and health authorities all have important roles to play in risk...
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be...
Pharmacology is the study of how a medicine works, how the body responds to it, and the changes that occur over time. There are two key areas of pharmacology:...
EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in...
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