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For a number of reasons, the relevant guidelines – which are the regulatory basis for all action – are frequently either not understood, not even read, or both. This is, however, an essential prerequisite if these regulatory requirements are to be met in the day-to-day operations of this industry.
Bearing this in mind, the concept behind the PharmAudio Guidelines Audio Book Series is to provide support by publishing the relevant regulatory guidelines as Audio Books. This enables interested experts to familiarize themselves with regulatory requirements beyond reading the available printed media. There are so many opportunities to listen to audio books, for example when you’re travelling, or having to kill time, while you’re in the gym or in the car. Admittedly regulatory texts don’t make for such exciting reading as novels or thrillers, which are the typical type of audio books, however, these guidelines are very important for professionals in the pharmaceutical industry working in the field of GMP.
In order
Bearing this in mind, the concept behind the PharmAudio Guidelines Audio Book Series is to provide support by publishing the relevant regulatory guidelines as Audio Books. This enables interested experts to familiarize themselves with regulatory requirements beyond reading the available printed media. There are so many opportunities to listen to audio books, for example when you’re travelling, or having to kill time, while you’re in the gym or in the car. Admittedly regulatory texts don’t make for such exciting reading as novels or thrillers, which are the typical type of audio books, however, these guidelines are very important for professionals in the pharmaceutical industry working in the field of GMP.
In order
Understanding Pharma Guidelines: EU GMP Annex 13
Investigational Medicinal Products: Complexity Meets Reality
aus dem Deutschen übersetzt von Heather FysonThis PharmAudio Guidelines Audio Book deals with the contents of EU GMP Annex 13, which describes the regulatory requirements to be followed for the manufacture, quality control, release and distribution of investigational medicinal products (hereafter referred to as IMP). Internationally, Annex 13 is considered to be the most detailed guideline on this topic and thus represents a global regulatory standard in this field.
Unfortunately, the processes and coherences involved in preparing investigational medicinal products are very complex. This is why operators and professionals not yet very familiar with the fundamentals and details of the GMP environment may have difficulties in practically applying prior GMP knowledge in this field.
The aim of PharmAudio Guidelines audio book is to support the listener in applying the contents of Annex 13. It is therefore mainly intended for people with advanced knowledge about and experience with GMP.
Unfortunately, the processes and coherences involved in preparing investigational medicinal products are very complex. This is why operators and professionals not yet very familiar with the fundamentals and details of the GMP environment may have difficulties in practically applying prior GMP knowledge in this field.
The aim of PharmAudio Guidelines audio book is to support the listener in applying the contents of Annex 13. It is therefore mainly intended for people with advanced knowledge about and experience with GMP.