Project Main Details
"This course has four sections. You can complete the entire course or only the section(s) that are most helpful to you, progressing through the sections in the order you prefer. Throughout the course, click Next to move forward. Click the buttons below to learn what is covered in each section.
This course describes the process by which an applicant obtains approval to market products in the European Union, or EU, and the Economic Area, including the roles of the agencies responsible for approving medicinal products in the EU and of marketing authorisation applicants and holders. After you have finished this course, you should be able to complete these objectives.
To understand the EU regulatory environment it is necessary to know the overall structure of the EU. Currently, the EU includes the individual countries, known as Member states shown here. In addition Iceland, Norway and Liechtenstein follow EU regulatory procedures and together with the Member States are referred to as the European Economic Area or EEA.
The European Regulatory Network is based on a coordinated network of National Competent Authorities or NCAs and the National Regulatory Authorities or NRAs, from each Member State who work together with the European Medicines Agency, or EMA and the European Commission in the EEA. The Heads of Medicines Agencies forum or HMA is comprised of the heads of the NCAs and is also part of the network. The EU Regulatory Network is linked by an IT network called Eudra-Net. Let’s take a closer look at each of these governing authorities. Point to each organization to learn more.
Can you choose the correct role? Drag the governing authority on the left to its definition on the right. Then click Submit.
Do you remember the relationships? Drag each authority on the left to its correct location in the diagram on the right." 2016-10-12 18:29:47 GMT 2016-10-17 12:03:18 (GMT -07:00) Mountain Time (US & Canada) Yes (click here to learn more about ) Closed - Note: This project was manually closed by the voice seeker before it reached its original deadline. 10 6 0 direct invitation(s) have been sent by the voice seeker resulting in 0 audition(s) and/or proposal(s) so far. Voice123 SmartCast is seeking 20 auditions and/or proposals for this project (approx.) Invitations sent by SmartCast have resulted in 10 audition(s) and/or proposal(s) so far.
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