Pharmaceutical Contracts: GMP and Legal Compliance 15-16 April 2010 Budapest, Hungary Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (EUR 1605,--) Book this option: QP Association Members (EUR 1521,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives Three prerequisites are needed to work out contracts which are legally and GMP compliant: awareness of the GMP requirements applicable legal and juristic knowledge the practical perspective. During this course you will learn how to cover all these relevant aspects. Get to know possibilities and tools to realise compliant contracts which can be deployed in your daily work. Background Not only caused by increasing contract manufacture and analysis, every pharmaceutical company establishes business connexions with a number of suppliers and service providers. The regulating authorities call for correctly defined, agreed and controlled contracted services. EU GMP Guide and international legislation require a written contract between the partners which clearly establishes the duties of each party. By compiling these contracts it is of extreme importance not only to meet the legal expectations. The company and the responsible persons need to be aware of their tasks and their liability. Not to mention that the contents should be easily transferable into the daily work and must be reduced to practice. The speakers in this education course have a substantial knowledge in the design and implementation of contracts in the pharmaceutical industry. You will get first hand practical information. Every participant will get a CD with various contract examples: Agreement on Contract Manufacturing of - Medicinal Products - Medical Devices - Foodstuffs Contract Testing of Medicinal Products Agreement on Quality Assurance concerning - Starting Materials - Transport of Medicinal Products Prepared by the German Medicines Manufacturers' Association (BAH)