Contact Person
    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
    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

    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)
    External presentation

    Afternoon:

    12:45

    Lunch – Open discussion

    13:45

    Revised versions of the EXCiPACT™ standard and IPEC GMP and GDP guides
    Dr. Ulrich Reichert, Head of Pharma and Food Materials, Regulatory Management,
    Life Science, Merck

    14:45

    USP <665> – New requirements for polymers in pharmaceutical manufacturing
    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:

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

    Torsten Schadendorf
    Associate Director Emprove® Marketing
    Merck

    Organized by:

    In collaboration with: