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

Pharmaceutical raw material regulations: Latest updates

September 19, 2018  |  9:00 – 16:00  |  Medicon Valley Alliance Copenhagen, Denmark


Regulations relative to pharmaceutical raw materials are ever evolving.

Meet with industry leaders on September 19th in Copenhagen to better understand these regulations and share experiences on their implementation.

We look forward to meeting you.

For more information, contact:
Anastasia Sommer
Field Marketing, Actives & Formulation



9:00 – 9:30Meet & Greet / Registration
9:30 – 9:45Introduction
 Jeroen de Boer, Actives and Formulation, Sales Manager Nordics, UK, Merck
Nicola Neary, Pharma Processing, Sales Manager Nordics, UK, Ireland, Merck
9:45 – 10:30Elemental impurities – Implementation approaches
 Dr. Ulrich Reichert, Head of Pharma and Food Materials,
Regulatory Management, Life Science, Merck
10:30 – 11:30EU formalized risk assessment for excipients - Facilitate risk assessment with Emprove® excipients (including new content: TUPP, Emprove® Evolve)
 Dr. Torsten Schadendorf, Associate Director Emprove® Marketing, Merck
11:30 – 11:45Break - Open discussion
11:45 – 12:15Qualification of single-use equipment used for clinical production in
Novo Nordisk
 Lisa Katharina Tscahmmer, Material Responsible GMP Raw Materials, Novo Nordisk
12:15 – 12:45Qualification of raw materials used for clinical production in Novo Nordisk
 Jeanet Kring, Senior Development Scientist, CMC API Material Responsible, Novo Nordisk
12:45 – 13:45Lunch - Open discussion
13:45 – 14:45Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides
 Dr. Ulrich Reichert
14:45 – 15:30USP <665> – New requirements for polymers in pharmaceutical manufacturing
 Dr. Ulrich Reichert
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 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: Medicon Valley Alliance

Conference room: Auditorium, ground floor

Arne Jacobsens Allé 15, 2.
Ørestad City
DK-2300 Copenhagen S