LOG IN OR SIGN UP TO "MY Eu2P"MEDICINES RISK IDENTIFICATION AND QUANTIFICATION
| INTRODUCTION TO RISK MANAGEMENT PLAN (RPM) | |
This course aims to introduce the topic on risk management plans and give some basic information to better understand the key aspects. |
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| 30 minutes | |
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English |
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| PHARMACOVIGILANCE PLAN VERSUS RISK MINIMIZATION PLANS | |
This course aims to present objectives and activities to be proposed in the two sections of the Risk Management Plan:
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| 180 minutes | |
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English |
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| RISK MANAGEMENT PLANS AND EUROPEAN UNION REGULATORY PERSPECTIVE | |
This 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. |
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| 120 minutes | |
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English |
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| CONCEPTS IN RISK MANAGEMENT | |
The course aims to give you an overview and to define the concepts necessary to built a risk management plan for medicinal product. |
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| 180 minutes | |
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English |
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| ORGANIZATION FOR RISK MANAGEMENT IN THE INDUSTRY | |
This course aims, based on the experience of a large international pharmaceutical company, to define the general principles necessary to build a process for developing Risk Management Plans for a medicinal product by the Industry. |
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| 180 minutes | |
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English |
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| METHODS AND NEW INITIATIVES FOR SIGNALS DETECTION | |
The objectives of this course are to:
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| 360 minutes | |
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English |
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