Note: This webinar took place on 8 February 2018. You can find a video recording and the presentations used during the webinar below. Webinar introduction A patient registry is an organised...
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...
A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose...
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 trials (Phase I and II) must establish above all that an investigational medicinal product is safe for humans, as well as to show that the medicine is...
GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...
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...
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...
The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative...
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.OkPrivacy policy
