Here you find abstracts of selected articles of issue 09/2010 of September 29, 2010 (subject to modifications).

Arzneimittelwesen • Gesundheitspolitik • Industrie und Gesellschaft

Pharma-Markt

Neue Medien in der pharmazeutischen Industrie Wie digitales Marketing nachhaltiges Wachstum fördert Die Pharmaindustrie befindet sich im Umbruch. Mit dem Ablauf zahlreicher Blockbuster-Patente erwarten Hersteller für die Jahre 2007 bis 2012 einen Umsatzrückgang von rund 115 Milliarden USDollar weltweit. Überdies verändern sich Kundenstrukturen und -verhalten fundamental: Neben Allgemeinmedizinern und Fachärzten entscheiden zunehmend auch Patienten, Apotheken und Krankenkassen über die Arzneimittelvergabe. Pharmaunternehmen stehen vor der Herausforderung, eine größere Zahl von Kunden über zunehmend komplexe Produkte und Märkte in immer kürzerer Zeit und mit immer weniger Ressourcen zu informieren, um im engen Wettbewerb zu gewinnen. Neue digitale Technologien und der Wandel zu einer konsequent digital gestützten Interaktion mit dem Kunden bergen hier entscheidende Erfolgs- und Einsparpotenziale.

Originale

Vorstellung GAMP 5 GAMP 5/Introduction – Overview Former versions of GAMP 5 preferred the V-model as the – more or less – only paradigm for the development of computerized systems. GAMP" 5 changed this approach, now current trends in software engineering are viewed as equal to the V-model by the authors. No model is anymore preferred. Since GAMP 5 it is important that the development follows the life cycle of a computerized system as well as the Quality by Design approach, which means that quality must be engineered into the system (source code) because documentation gives not the only evidence. Predecessor versions of GAMP 5 already tried to define scalability but that goal was not completely reached. Now, with the toolbox of GAMP 5, scalability is easier to implement. Determining factors for scalability in GAMP 5 are 1) category of a system, 2) impact to patient safety, 3) complexity and novelty of a system, 4) result of supplier evaluation and 5) risk assessment. Nowadays most of the systems used in regulated industry are pre-configured and pre-tested by their suppliers. Therefore, instead of a widespread testing, a more focused testing of functions that can affect patient safety should be outlined. But – of course – a supplier who is working along a predefined Quality Management system is a precondition for a reduced and focused testing to be sufficient. Dealing with other topics like CSV in embedded systems, use of open source products and handling of data when doing data migration from a legacy system to a new system makes GAMP 5 an industry guideline where the subtitle “CSV in an economic way” meets its contents.

Originale

Methodisches Management von IT-Validierungsprojekten Methodical Management of IT Validation Projects Efficient management of projects is an art, as it requires balancing budget constraints, committed delivery dates, and compliance requirements. This is often challenging, particularly in the area of validation of IT systems. Based on best practices, the following article describes a structured approach to manage IT projects, ensuring compliance with the validation requirements for IT systems used in GxP-regulated environment.

Originale

Risikomanagement nach GAMP 5 Risk Management According to GAMP 5 GAMP" 5 transfers risk management according to ICH guideline Q9 and/or Annex 20 to the practical application in computerized systems validation. Following a life-cycle approach, GAMP defines seven building blocks any risk management is composed of. Starting with risk based decisions on whether a system has to be validated at all, explicit and detailed risk assessments are requested from all quality or GxP relevant decision points. Risk management only ends with the controlled and supervised system retirement; potential GxP risk concerns must always be taken into consideration when shutdown processes are planned. The seven risk management building blocks facilitate the implementation of the required “risk-based approach”. Some deficiencies in operational feedback and the inclusion of feedback data into the risk management process remain; however, the periodic review process offers a feasible solution for this problem. Therefore, the GAMP 5 risk management approach constitutes an essential, indispensable element of efficient validation: GxP risks are the only recognized and acknowledged decision criteria for what must and must not be done during validation.