Clinical Evaluation for EU Market Approval: Process and Regulatory background
This course provides an expert overview of EU regulations and how they positively impact global market access. It includes a detailed outline of the necessary steps to achieve immediate and lasting compliance of clinical evaluations.
Note: Manufacturers planning to market their devices in Europe are required to furnish clinical data in accordance with European directives.
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Upon successfully completing this course, learners will be able to:
- Distinguish different methods of obtaining clinical data for EU market access
- Understand how the conduct of a critical review of existing data is the basis for deciding whether to embark on a prospective clinical investigation or not
Senior clinical and regulatory managers, clinical research directors and vice presidents, medical writers, regulatory affairs directors, and regulatory affairs vice presidents involved in the strategic planning of clinical evaluations for the EU and medical device global market access are all encouraged to participate in this course.
The following courses are required:
- The European Union Regulatory System for Medical Devices (ID 145)
- ISO 14155: 2011 - A Summary Review (ID 144)