Forum
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
anastasia.sommer@merckgroup.com
Agenda*
| 9:00 – 9:30 | Meet & Greet / Registration |
| 9:30 – 9:45 | Introduction |
| Jeroen de Boer, Actives and Formulation, Sales Manager Nordics, UK, Merck Nicola Neary, Pharma Processing, Sales Manager Nordics, UK, Ireland, Merck | |
| 9:45 – 10:30 | Elemental impurities – Implementation approaches |
| Dr. Ulrich Reichert, Head of Pharma and Food Materials, Regulatory Management, Life Science, Merck | |
| 10:30 – 11:30 | 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 – 11:45 | Break - Open discussion |
| 11:45 – 12:15 | Qualification of single-use equipment used for clinical production in Novo Nordisk |
| Lisa Katharina Tscahmmer, Material Responsible GMP Raw Materials, Novo Nordisk | |
| 12:15 – 12:45 | Qualification of raw materials used for clinical production in Novo Nordisk |
| Jeanet Kring, Senior Development Scientist, CMC API Material Responsible, Novo Nordisk | |
| 12:45 – 13:45 | Lunch - Open discussion |
| 13:45 – 14:45 | Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides |
| Dr. Ulrich Reichert | |
| 14:45 – 15:30 | USP <665> – New requirements for polymers in pharmaceutical manufacturing |
| Dr. Ulrich Reichert | |
| 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 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
Denmark