Results found: 35

The Regulatory Affairs function was created to protect public health, monitor the safety and efficacy of pharmaceuticals, medical devices (MD), in vitro diagnostic (IVD) devices, dietary supplements, and cosmetics, among others.

The medical sector is constantly evolving and becoming increasingly competitive. As a result, regulations are becoming stricter and more stringent.
There is an increasing tendency to move towards the same regulatory framework for each member state of the European Union (e.g., through RE 536/2014; MDR 2017/45; and IVDR 2017/46). Still, often national decrees are issued to implement international regulations, resulting in a varied and complex regulatory landscape.

Regulatory Affairs professionals (also known as Regulatory Affairs Specialists) must navigate through, different legislation, regulations and implementing decrees to fulfil responsibilities related to regulatory compliance, submissions, certifications, dossier maintenance, etc.

Regulatory work is a complex process that requires several professionals, each with different competences - in technical, scientific, administrative, and soft skills.

Regulatory courses are aimed at all those working in the world of pharmaceuticals, medical devices (MD), in vitro (IVD), food supplements, and cosmetics who are interested in acquiring and/or updating their regulatory knowledge through discussions with experts.