This webinar aims to provide a short introduction into the regulatory requirements of excipients in Marketing Authorization Applications in Europe. References to excipients in the guidelines for the dossier for application for marketing authorization of a medicinal product and examples are discussed. A further attention is turned on the supplier approval process to fulfill the requirements according to a formalized risk assessment for ascertaining the appropriate GMP practice for excipients.
Darek Lewin, Head of Quality, J. Rettenmaier & Söhne GmbH + Co KG (JRS Pharma)
Darek Lewin graduated in “Technology of Renewable Raw Materials” in 2001 at the University of Applied Sciences Hannover. In 2003, he was employed as the Project Manager for “Microencapsulation of Probiotic Bacteria” at J. Rettenmaier & Söhne GmbH & Co KG, Rosenberg, Germany, a world-wide, dynamic leader in the fiber industry. JRS provides with their fiber products solutions for various applications and chemical processes for almost every field of daily life, i.e. for pharmaceutical and food applications, or for technical and industrial use. From 2004 to 2006, he was responsible as the Food and Feed Safety Manager and then as Corporate Quality Manager for JRS Pharma GmbH & Co KG. JRS Pharma is currently the biggest producer of Microcrystalline Cellulose worldwide. Additionally, JRS Pharma serves the pharmaceutical industry with a family of high functional solid excipients. Since 2007, Darek Lewin is the Head of Quality for the JRS Group with production plants in Europe, USA, India, China and Mexico.
IPEC Europe Members: 60 € (excl. VAT)
IPEC Europe Non Members: 80 € (excl. VAT)