Docente
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SICLARI DOMENICO
(programma)
Regulation of health services - European Union Rights and Values in Human Health - EU 'Public Health' and 'Health Care' Law and Policy - General principles of pharmaceutical markets regulation - Evolution of the registration process - Regulation of international bodies - Regulatory systems in Europe, US, rest of the world - The preparation and submission of marketing authorisation applications in major countries - Approval, appeals and referral processes in Europe - Updating and maintaining marketing authorisation - Aspects of confidentiality and transparency - Regulation of product information - Compassionate use - Off label use and misuse.
 REQUIRED READINGS:
A. de Ruijter, EU Health Law & Policy. The Expansion of EU Power in Public Health and Health Care, Oxford University Press, 2019
Only recommended readings:
S. Shorthose, Guide To EU Pharmaceutical Regulatory Law, Seventh Edition, Kluwer, 2017
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