Risk management plans and European Union regulatory perspective
OBJECTIVESThis course aims to introduce the different aspects to take into account as philosophical aspects, risk perception concepts but also guidance to take into account as Risk Management Plan for European Medicines Agency, International Committee Harmonization E2E, Committee for Human Medicinal Product guidance and new legislation.
LEARNING OUTCOMESAt the end of the course, you will gain knowledge in
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AUTHORS
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John Talbot AstraZeneca AB |
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Dr. Sabine Straus Associate professor & Chair of the Pharmacovigilance and Risk Assessment Committee (PRAC) |