15. GMP-Konferenz: vom EU-Pharma-Paket bis zum Lieferantenmanagement
EU-Pharmapaket / Risikomanagementsysteme / GMP-Inspektionen / Lieferantenqualifizierung / 15. AMG-Novelle
Bericht von einer Konferenz der Hochschule Albstadt-Sigmaringen mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS Training Service am 23./24. November 2009 in München
Reinhard Schnettler1, Prof. Dr. Ingrid Müller2 und Cornelia Wawretschek1
PTS Training Service1, Arnsberg, und Hochschule Albstadt-Sigmaringen2
The European Union Government presented proposals for three new regulations regarding secure and innovative pharmaceutical products with reasonable prices and also a proposal in order to strengthen the pharmacovigilance-system.
For all patients the demand for high potential and secure pharmaceutical products is of high priority. The risk-tolerance in our current society is significantly lower than in former times. In order to minimize risks risk management systems are essential. At the same time the expectation of a zero-risk-level is not realistic and a remaining risk is unavoidable.
Currently many parts of the whole supply chain are subject to outsourcing. Nevertheless the responsibility for the pharmaceutical products remains at the license owner. In order to follow this responsibility three mayor points have to be taken in consideration: contracts, confidence and control by companies and authorities.
The conference was completed by discussions and round tables groups.