C2-M5 Regulatory Affairs, Medicinal Product Safety, Pharmacovigilance and Pharmacoepidemiology

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Learning outcomes module 5:

5A  Critically review the current EU regulatory requirements (pre and post-authorisation) for a medicinal product

5B  Critically evaluate the pharmacovigilance of a medicinal product and the role of the various stakeholders

5C  Discuss the various aspects of shortages of medicines and the role the different stakeholders

5D  Discuss the role and importance of Regulatory Agencies and other stakeholders in particular patients/patient organizations throughout the lifecycle of a medicinal product

5E  Describe the provisions of (1) off label use (2) compassionate use and (3) controlled medicinal products at a national and EU level

5F  Outline the legislative background and review processes product information

5G  Explain the role of different organizations in the development and implementation of regulatory legislation in Europe

5H  Critically discuss treatment compliance and comprehension

5I  Locate and navigate regulatory agencies’ websites and sources of information on medicinal product interactions

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