Second international awareness session for international regulators, academia and non-governmental organisations

• Date:
  Πέμπτη, 8 Μάρτιος 2018, Ολοήμερο
• Τόπος:
  European Medicines Agency, Amsterdam, the Netherlands

This two-day awareness session for international regulators , academia and non-governmental organisations (NGOs) will give 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. It will address topics including the role of experts and benefit-risk evaluation. It will also provide networking opportunities with academics, NGOs staff and regulators from and outside the European Union. The event will be broadcast live. EMA will publish further material after the event.

Documents

Agenda - Second international awareness session for international regulators, academia and non-governmental organisations

Reference Number: EMA/829042/2017

Presentation - Module 1 - Setting the scene: Introduction to the EU regulatory network

Presentation - Module 2 - Engagement with stakeholders

Presentation - Module 3 - Early engagement on medicine development

Presentation - Module 4 - Advanced therapy medicinal products (ATMPs)

Presentation - Module 5 - Clinical trials in the European Union

Presentation - Module 6 - EMA support to innovation

Presentation - Module 7 - Benefit-risk assessment and good regulatory practice

Presentation - Module 8 - Dealing with specific populations and types of products

Presentation - Module 9 - Good practice and inspections

Presentation - Module 10 - Patient safety and pharmacovigilance

Presentation - Module 11 - International cooperation

Multimedia