Home>Events>Forum | Pharmaceutical raw material regulations: Latest updates

Forum
Pharmaceutical raw material regulations: Latest updates

February 20, 2018  |  9:00 - 16:00  |  Babraham Institute, Cambridge, UK

MilliporeSigma

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.

For more information and registration, contact:

Anastasia Sommer
Technology Management, Actives & Formulation
anastasia.sommer@emdgroup.com

Agenda*

 
9:00 - 9:15Meet & Greet
 
9:15 - 9:30Introduction
 Jeroen de Boer, Actives and Formulation, Sales Manager Nordics, UK, Merck KGaA, Darmstadt, Germany
 
9:30 - 10:15Elemental impurities - Implementation approaches
 Dr. Lars Albermann, Pharma and Food Subject Matter Experts
Quality and Regulatory Management, Merck KGaA, Darmstadt, Germany
 
10:15 - 11:00EU formalized risk assessment for excipients - Facilitate risk assessment with Emprove® excipients
 Dr. Torsten Schadendorf, Associate Director Emprove® Marketing, Merck KGaA, Darmstadt, Germany
 
11:00 - 11:30Break - Open discussion
 
11:30 - 12:30Current 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 - 13:45Lunch - Open discussion
 
13:45 - 14:45Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides
 Dr. Lars Albermann
 
14:45 - 15:30USP <665> - New requirements for polymers in pharmaceutical manufacturing
 Dr. Lars Albermann
 
15:30 - 16:00Open 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.

Venue: Babraham Institute

Conference room: King’s Hedges
Babraham Hall, Babraham
Cambridge CB22 3AT, UK
+44 1223 496000