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Pharmaceutical raw material regulations: latest updates – MVA Boost Seminar

September 19, 2018 @ 09:00 - 16:00

Regulations relative to pharmaceutical raw materials are ever evolving.

Meet with industry leaders to better understand these regulations and share experiences on their implementation.

Date: 19 September 2018
Time: 9:00 – 16:00
Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor




9:00 Meet & Greet
9:30 Introduction
Jeroen De Boer, Actives and Formulation, Sales Manager Nordics, UK, Merck
Nicola Neary, Pharma Processing, Sales Manager Nordics, UK, Ireland, Merck
9:45 Elemental impurities – Implementation approaches
Dr. Lars Albermann, Pharma and Food Subject Matter Experts
Quality and Regulatory Management, Merck
10:30 EU 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 Break – Open discussion
11:45 Perspectives on how to handle qualifications and maintenance of starting material suppliers for the pharmaceutical industry (with increasing requirements and difficulties to have access for on-site audits)
Åke Hansson,Audit Manager, Quality Management, Recipharm AB, Sweden


12:45 Lunch – Open discussion
13:45 Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides
Dr. Lars Albermann, Senior Regulatory Affairs Manager, Merck Life Sciences
14:45 USP <665> – New requirements for polymers in pharmaceutical manufacturing
Dr. Lars Albermann, Senior Regulatory Affairs Manager, Merck Life Sciences
15:30 Open discussion – Wrap-up
16:00 End of meeting


September 19, 2018
09:00 - 16:00
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