Principles and Practice of Pharmaceutical Medicine

in Japan. However, the clinical development of a foreign drug has to be duplicated in Japan from phase I to phase III, because o ...

Data for review as powerful, poisonous drug and so on. Draft plan and protocol for PMS. List of attached documentation. Other d ...

NDA. At this stage, within six months after appli- cation, a hearing is generally held between the reviewers and the sponsor, wh ...

Medical Device Monitoring System. Another similar system reports to the MHLW the pro- blems encountered with medical devices.  ...

Reexamination aims at confirming the conclu- sions from the drug approval and particularly the daily recommended dose, treatment ...

medical departments for clinical R&D and to assess ADRs. The predominant role of the inves- tigators will decrease. The drug ...

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36 Drug Registration and Pricing in the Middle East Edda Freidank-Mueschenborn 36.1 The market Commercial and cultural backgroun ...

each country. These control the whole process of product approval from application formats to pricing. A small exception is in E ...

Good Manufacturing Practice (GMP) compli- ance. Research & Development (R&D) activities. Product information. There a ...

Pharmacy only, and there are differences (with sub-classes for over-the-counter (OTC) products and herbal medicines. Food supp ...

Jordan and Oman). Otherwise, the language can be English and/or Arabic. Nonetheless, inadvertent offencemustbe avoidedinthese re ...

well respected, the very form of the notarization can cause concern. For example, Jordan only accepts documents from the German ...

Approval of quality control laboratories. Review of technical and post-marketing surveil- lance reports. Responsible for the ...

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SECTION VI Medical Services Introduction This section covers the area that is typically termed ‘Medical Affairs’ in pharmaceutic ...

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37 Medical Affairs Gregory P. Geba 37.1 Introduction The role of clinical trials in evaluating efficacy and safety of drugs exte ...

research is often referred to as phase IIIb, if con- ducted prior to or after dossier submission, but prior to marketing approva ...

research at all levels, the approach today is much more robust and defined, largely driven by industry- initiated efforts to mak ...