Regulatory Open Forum

 View Only

Webinar alert: Navigating regulatory grey zone for Ancillary Materials for cell and gene therapy

  • 1.  Webinar alert: Navigating regulatory grey zone for Ancillary Materials for cell and gene therapy

    Posted 15-Jan-2024 09:25

    👋 Everybody in #Vancouver and else where.

    This is a unique opportunity to learn about regulatory pathways for Ancillary Materials (AMs) used in Cell and Gene Therapy and how Vancouver HQed STEMCELL Technologies, largest Canadian Biotech company with global footprint, has been navigating these challenges.

    RAPS Westen Canada Chapter is thrilled to start 2024 with an insightful online webinar



    People often think that Regulatory Affairs navigates the clear-cut regulations for products under the purview of Regulatory Agencies, but what if there are no regulations for that type of product? How does a business create a regulatory strategy for products in the gray zone, such as Ancillary Materials (AMs) used in the manufacture of cell and gene therapies?

    Join Lynn Csontos, RAC , VP of Regulatory Affairs at STEMCELL, as she walks through tactics on how to leverage a risk based approach to meet the compliance needs of the market.

    Save the date, registration details coming soon!



    ------------------------------
    Hasnaa FATEHI
    MedTech Regulatory and Quality Assurance
    QARALogic
    Vancouver BC
    Canada
    ------------------------------