Overcoming Regulatory Challenges for Cell & Gene Therapy Products

Bringing an Advanced Therapy Medicinal Product (ATMP) to market is a complex process, requiring a deep understanding of regulatory requirements, scientific rigor, and compliance excellence. With increasing scrutiny from regulatory authorities such as the FDA and EMA, pharmaceutical companies must proactively address compliance challenges for cell-based therapies, gene therapies, and combined ATMPs.

In this exclusive on-demand webinar, our experts explore strategic approaches to overcoming ATMP regulatory hurdles, ensuring compliance, and streamlining approvals in global markets.

Don’t miss this opportunity to enhance your regulatory skills and understanding.

Webinar Speakers

  • Maurice Bancsi, Principal SME & Head RA, Celegence
    Maurice has 28+ years of experience in pharmaceutical and biotech regulatory affairs, specializing in regulatory strategy, global submissions, and compliance for pre-approval drugs and biologics across oncology, pulmonary, and cardiovascular indications.

  • Kattia Lonsdale, Regulatory Consultant, Silva Correia Regulatory Ltd
    Kattia has 13+ years of experience specializing in gene and cell therapy regulatory affairs, spanning early-phase to post-authorization compliance across global markets, including the USA, LATAM, and Europe.

What You’ll Learn:

  • Key ATMP regulatory requirements in the US & EU

  • Best practices for navigating complex submission pathways

  • Addressing common challenges in cell & gene therapy compliance

  • Expert insights into literature reviews, clinical data, and dossier preparation

  • Actionable strategies for accelerating regulatory approvals

Who Should Watch?

  • Regulatory professionals managing ATMP compliance
  • Medical & regulatory writers working on literature reviews and submissions

  • Quality teams & compliance officers overseeing dossier preparation

  • Cell & gene therapy manufacturers seeking regulatory insights

Explore More on ATMP Regulatory Challenges

Are you seeking assistance with a regulatory compliance need?

Please complete the form below to outline your medical device/pharmaceutical/IVD regulatory support requirements. Our team will promptly review your submission and reach out to confirm a consultation time. Thank you for your interest.