| 1 x | EU-MDR 2017/745 Review for Clinical Professionals | € 234.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations | € 84.00 |
| 1 x | Ethics Committee(EC) / Institutional Review Board Requirements | € 143.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Close Out | € 90.00 |
| 1 x | Effective Monitoring of Medical Device Clinical Investigations | € 1’517.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
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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