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 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