Gxp in Pharma MasterClass
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From the idea to the patient
Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products from pharmacies to pharmaceutical companies. Meanwhile we have a big variety of laws, regulations and guideline, which accompany the different phases of the approximately 12 year from the first idea until a new medicinal product is available for the patient. This seminar want’s to give an overview of the relevant good working practices and provides the connection to the life cycle of a medicinal product. The main focus here is on the Good development practice, Good Manufacturing Practice and Good Distribution Practice in combination with the life cycle of a Medicinal Products.