7. GMP-Konferenz „Miteinander reden heißt, die Zukunft gestalten“ Bericht von einer Konferenz der Hochschule für Wirtschaft und Technik, Sigmaringen, und PTS Training Service, Arnsberg, mit EMEA, ICH und europäischen Inspektoraten am 4./5. Dezember 2001 in Darmstadt Reinhard Schnettler, Christine Oechslein und Anita Maas Herrn Dr. Peter Herbst (†) in ehrendem Gedenken gewidmet “Communication between regulatory authrities and the pharmaceutical industry” and the further development of this maxim for the future was the main topic of the 7th GMP conference.
The consequences of last year’s global events - ICH 5 with the Common Technical Document (CTD) and the Mutual Recognition Agreement (MRA) with the USA - could clearly be felt this year for the first time. The impact of these changes was also visible in the field of inspections: restructuring, setting up thematic areas of priority and the pooling of activities in the ZLG in Germany (Central Authority of the Laender for Drug Products and Medicinal Products) point to a radically changing situation in the pharmaceutical industry. The 7th GMP conference reflected these developments; representatives of German authorities presented the new structures in a detailed way, e.g. concepts for the handling of adverse events with drugs, inspections, validation and computerized systems. Furthermore, representatives of the European authorities (EMEA, European Medicines Evaluation Agency; CPMP, Committee for Proprietary Medicinal Products) gave first-hand information on the European situation and ICH (International Conference on Harmonization) activities. The Quality System Inspection Technique (QSIT) as a method for inspections in the USA was also presented. QSIT is in use since mid-2001 in several districts and will influence inspections outside the USA. |
