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Eu Gmp Annex 13
- Investigational Medicinal Products, Complexity Meets Reality
- ナレーター： Rango Dietrich, Alison Rippier, Joseph Rippier
- 再生時間： 1 時間 35 分
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Eu Gmp Annex 13
ナレーター：
Rango Dietrich, Alison Rippier, Joseph Rippier
あらすじ・解説
Get to know more about the scope and limits of complex regulatory guidelines!
Implementing pharmaceutical regulatory guidelines is a complex matter. Reading these regulatory procedures, understanding them and putting them into practice not only requires time but often also assistance - and here it is: the current regulatory guidelines as an audiobook with qualified comments based on long years of industrial and consulting experience.
The requirements stipulated by GMP (Good Manufacturing Practice) for the preparation of investigational medicinal products are regulated in Annex 13. Many interfaces to GCP (Good Clinical Practice), the QP (Qualified Person) and to the entire supply chain have to be translated professionally into real processes. Dr Rango Dietrich provides comments on the most important texts, drawing on over twenty years of experience, to make the texts easier for the listener to understand.
Please note: This audiobook is in English.
Implementing pharmaceutical regulatory guidelines is a complex matter. Reading these regulatory procedures, understanding them and putting them into practice not only requires time but often also assistance - and here it is: the current regulatory guidelines as an audiobook with qualified comments based on long years of industrial and consulting experience.
The requirements stipulated by GMP (Good Manufacturing Practice) for the preparation of investigational medicinal products are regulated in Annex 13. Many interfaces to GCP (Good Clinical Practice), the QP (Qualified Person) and to the entire supply chain have to be translated professionally into real processes. Dr Rango Dietrich provides comments on the most important texts, drawing on over twenty years of experience, to make the texts easier for the listener to understand.
Please note: This audiobook is in English.
©2014 Pharmaudio Guidelines (P)2014 Pharmaudio Guidelines