Event info
Date:19 Sep
Time:9:00 - 16:00
Venue:Medicon Valley Alliance, Copenhagen S

Pharmaceutical raw material regulations: latest updates

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

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Agenda

Morning:

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
The ICH Q3D requires to conduct a risk based assessment of elemental impurities. The regulatory requirements of this guideline, the developments of the Pharmacopoeias Ph. Eur. and USP will be discussed. Emphasis will be laid on the implication on pharmaceutical starting materials such as APIs and excipients to develop a risk based approach to assess and control of elemental impurities.
Dr. Ulrich Reichert, Head of Pharma and Food Materials, Regulatory Management, Life Science, 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

Qualification of Single-Use Equipment used for Clinical Production in Novo Nordisk
Lisa Katharina Tscahmmer, Material Responsible GMP Raw Materials, Novo Nordisk

Qualification of Raw Materials used for Clinical Production in Novo Nordisk
Jeanet Kring, Senior Development Scientist, CMC API Material Responsible, Novo 

Afternoon:

12:45

Lunch – Open discussion

13:45

Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides
Significant standards and guidelines relevant for excipients have been revised recently. The EXCiPACT TM standard, the IPEC PQG Guide on Good Manufacturing Practices as well as the IPEC Good Distribution Practice Guide have undergone revisions. This presentation covers an update on the latest developments on IPEC guides.
Dr. Ulrich Reichert, Head of Pharma and Food Materials, Regulatory Management, Life Science, Merck

14:45

USP <665>: Upcoming requirements for polymeric systems in biopharmaceutical production
The USP drafted a new chapter <665> to set requirements for polymeric components and systems used in the manufacturing of pharmaceutical and biopharmaceutical drug products. This draft guideline will impact Single Use System for biopharmaceutical production. The presentation covers implications and approaches to fulfill the new requirements.
Dr. Ulrich Reichert, Head of Pharma and Food Materials, Regulatory Management, Life Science, Merck

15:30

Open discussion – Wrap-up

16:00

End of meeting

Speakers:

 

Jeanet Kring
Senior Development Scientist
CMC API Material Responsible
Novo Nordisk

Lisa Katharina Tscahmmer
Material Responsible GMP Raw Materials
Novo Nordisk

Ulrich Reichert
Head of Pharma and Food Materials, Regulatory Management, Life Science
Merck

Torsten Schadendorf
Associate Director Emprove® Marketing
Merck

 

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