Cell and Gene Commercialization

  1. Pre-Launch Checklist - A Roadmap To Success 6/21/2024

    The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.

  2. Cell And Gene Therapy (CGT): Pre-Launch Checklist 6/17/2024

    Discover the ten questions to ask yourself and your commercialization partner to chart a comprehensive strategy that aims to support the successful advancement of your therapy.

  3. IP Considerations For Gene Editing In The Cell Therapy Space 6/13/2024

    It is crucial to monitor the IP landscape and file patent applications for advancements. By staying informed and proactive, companies can secure their position in the rapidly evolving CGT field.

  4. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

  5. EMA Services: Ensure Regulatory Success 6/5/2024

    Get support for post-authorization regulatory requirements, spanning product launches, management of variations, new indications, line extensions, and ensuring ongoing compliance to uphold your product's regulatory status throughout its lifecycle.

  6. Comparing FDA's Accelerated Approval And EMA's Conditional Marketing Authorization 6/5/2024

    Gain an understanding of how expedited regulatory pathways can shape the development and approval of therapies for critical medical needs.

  7. Key Steps To Creating A Successful Market Access Strategy 6/5/2024

    Learn how to create a successful market access strategy and navigate the complexities of pricing and reimbursement in Europe.

  8. The Trifecta Of Promotional Review: What Is A PRC And What Do They Do? 6/5/2024

    The mystique of the Promotional Review Committee (PRC) is unveiled – understanding what it is and why you need it is crucial for ensuring a successful promotional review.

  9. The Essential Guide To Local Person For PV 6/4/2024

    For all marketing authorization holders, ensuring a functional pharmacovigilance system is crucial. Make sure you have the right Local Persons for Pharmacovigilance (LPPVs) in the right place at the right time.

  10. The QPPV: A Guide For The Qualified Person Responsible For PV 6/4/2024

    Ensure compliance with EU and UK pharmacovigilance requirements by setting up a robust PV system with a Qualified Person Responsible for Pharmacovigilance (QPPV).