PlumeSTARS participated at the 2nd International Awareness Session – The EU medicines regulatory system and the European Medicines Agency which was held on 8 and 9 March in London (UK).

This two-day awareness session for international regulators and non-governmental organisations (NGOs) gave an insight into how the European medicines regulatory network works, the role of European Medicines Agency (EMA), scientific aspects of EMA’s work and its interaction with scientific experts.

Were discussed topics such as the role of experts and benefit-risk evaluation, networking opportunities with academics, NGOs staff and regulators from and outside the European Union.

You can download the slides here:

Module 01. Setting the scene, introduction to the EU regulatory network

Module 02. Engagement with stakeholders

Module 03. Early engagement on medicine development

Module 04. ATMPs

Module 05. Clinical Trials in the EU

Module 06. Hot topic, EMA support to innovation

Module 07. Benefit risk assessment and good regulatory practice

Module 08. Dealing with specific populations and types of products

Module 09. Good practice and inspections

Module 10. Patient safety and pharmacovigilance

Module 11. International cooperation