The implementation of health technology assessment principles in public decisions concerning orphan drugs

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چکیده

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چکیده: نسبت به کارکرد و ماهیت دیپلماسی عمومی در جهان امروز نظریه های متعددی بیان گردیده و جایگاه آن در کنار نظریه های دیگر در محافل آکادمیک و دانشگاهی بررسی و تحلیل گردیده است. نظر به اهمیت دیپلماسی عمومی و جایگاه آن در سیاست خارجی ایران این نوشتار با تمرکز بر دیپلماسی عمومی در منطقه آسیای مرکزی تهیه و تنظیم شده است. این ضرورت از آنجا ناشی می شود که اولاً مفهوم دیپلماسی عمومی در سیاست خارجی ای...

15 صفحه اول

Scientific and Social Value Judgments for Orphan Drugs in Health Technology Assessment.

OBJECTIVES We explore how broader aspects of a treatment's value and the impact of the condition on patients not captured by routine health technology assessment (HTA) methods using clinical and economic evidence, defined as "other considerations," may influence HTA processes in different settings. METHODS Countries included were England, Scotland, Sweden, and France. Data sources were the pu...

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Orphan drugs assessment in the centralised procedure.

On the basis of the author's experience as member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and in order to facilitate the access of new orphan drugs to the patients, some suggestions were given. Among these the following should be taken into account by the regulatory bodies: 1) conditional approval or approval under exceptional circumst...

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ژورنال

عنوان ژورنال: European Journal of Clinical Pharmacology

سال: 2020

ISSN: 0031-6970,1432-1041

DOI: 10.1007/s00228-020-02855-7