Regulations relative to pharmaceutical raw materials are ever evolving.
Meet with industry leaders on February 20th in Cambridge to better understand these regulations and share experiences on their implementation.
We look forward to meeting you.
Technology Management, Actives & Formulation
|9:00 - 9:15||Meet & Greet|
|9:15 - 9:30||Introduction|
|Jeroen de Boer, Actives and Formulation, Sales Manager Nordics, UK, Merck KGaA, Darmstadt, Germany|
|9:30 - 10:15||Elemental impurities - Implementation approaches|
|Dr. Lars Albermann, Pharma and Food Subject Matter Experts
Quality and Regulatory Management, Merck KGaA, Darmstadt, Germany
|10:15 - 11:00||EU formalized risk assessment for excipients - Facilitate risk assessment with Emprove® excipients|
|Dr. Torsten Schadendorf, Associate Director Emprove® Marketing, Merck KGaA, Darmstadt, Germany|
|11:00 - 11:30||Break - Open discussion|
|11:30 - 12:30||Current industry perspective on the compliance qualification of pharmaceutical incoming materials|
|Johannes Carteus, Head of Global Quality for Suppliers and Incoming Materials, GSK Belgium|
Laurence Colen, Chemicals Hub Leader, Global Quality for Suppliers and Incoming Materials, GSK Belgium
|12:30 - 13:45||Lunch - Open discussion|
|13:45 - 14:45||Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides|
|Dr. Lars Albermann|
|14:45 - 15:30||USP <665> - New requirements for polymers in pharmaceutical manufacturing|
|Dr. Lars Albermann|
|15:30 - 16:00||Open discussion - Wrap-up|
* Agenda subject to change. Attendance to the “Pharmaceutical raw material regulations: latest updates” forum is limited and available to pharma or biopharma manufacturers and academics only. The offer does not extend to any company that provides pharma or biopharma products or services. Merck KGaA, Darmstadt, Germany reserves the right to revoke or refuse participation at any time. The meeting is free of charge. Lunch and coffee breaks are provided compliments of Merck KGaA, Darmstadt, Germany. Hotel accommodations and travel costs are at the expense of the attendees.
Conference room: King’s Hedges
Babraham Hall, Babraham
Cambridge CB22 3AT, UK
+44 1223 496000