TERMIS-EU PAP – Session 3: Regulation

Written by Shiraz Ziya
Report

Introduction to regulation of products within the regenerative medicine industry.

TERMIS-EU PAP is a free programme of webinars open to entrepreneurial researchers at all stages of their career. It aims to help participants develop an understanding of the pre-market commercialisation challenges specific to the fields of tissue engineering and regenerative medicine (TERM). It also allows prospective commercial entities to address previously unaccounted risks and concerns. This will provide the necessary know-how in preparation of a business plan for the TERMIS-EU Business Plan Competition (BPC).

TERM products face a raft of regulatory hurdles that must be successfully navigated if products are to not only reach the market, but remain on the market while achieving commercial success. The exact regulatory route-to-market depends on the nature of the product, while the innovative nature of many advanced therapies frequently complicates adherence to existing frameworks. In this seminar we aim to cover:

  • Overview of the regulatory pathways available for ATMPs and other TERM products, including medical device classifications
  • Key regulatory requirements for developing ATMPs in the EU
  • Necessary ancillary activities for regulatory approvals
  • Commercial case study

    • CLICK HERE TO REGISTER for this live event on 19th December 2016.

    Dr. Christopher Bravery

    Director, Advanced Biologicals Ltd., UK
    Dr. Julian Hitchcock

    Counsel, Denoon Legal, London, UK

    We use GotoWebinar, please join ahead of time to avoid any connection issues. If you are unable to attend, each session will be recorded and available through our website.

    For more information on this webinar series, please visit our website: www.termisbpc.org/pre-accelerator