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    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634 Linkedin

    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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