Workshop 5: ADKA-Guidelines: Interactive discussion of the revised version of the ADKA-Guideline ‘Drug manufacturing and quality control’ and the draft guideline ‘Oncolytic viruses’ (German language)

7 October 2015

Irene Krämer Department of Pharmacy, University Medical Center,
Johannes Gutenberg-University, Langenbeckstraße 1,
55131 Mainz, Germany

The German Ordinance on the Operation of Pharmacies requires the implementation of a quality management system in each pharmacy. The quality management system should cover the manufacturing of medicinal products as well as pharmaceutical services. Guidelines of the professional societies (i.e. national chamber of pharmacy) aid the compilation of a quality management handbook. Guidelines covering topics which are especially relevant for hospital pharmacies are developed by the German Society of Hospital Pharmacists ADKA e.V. A revised version of the ADKA Guideline with the title: ‘Manufacturing and quality control of medicinal products’ is currently under consultation. Open questions, especially quality indicators and performance figures regarding drug manufacturing will be will be discussed in the workshop. Moreover numerous oncolytic viruses are under investigation in clinical trials and will undergo the licensure procedure. Therefore a guideline regarding the preparation of oncolytic viruses is to be developed and the cornerstones for the first draft to be determined during the workshop.

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