European Safety Reporting Requirements during Clinical Investigations
European Safety Reporting Requirements during Clinical Investigations
This course provides a review of the overall regulatory requirements for adverse event reporting during clinical investigations in Europe including an outline of the applicable documents and what the different reporting requirements are for both competent authorities and ethics committees. The course takes into account the requirements of EU-MDR and related MDCG 2020-10.
2 modules
€ 90.00
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