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Overcoming Regulatory Challenges for Cell & Gene Therapy Products

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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.

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

 

Explore More on ATMP Regulatory Challenges

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📖 ATMP Regulation in the EU and US: Global Convergence? – Learn about the regulatory alignment efforts between the FDA & EMA and what this means for ATMP manufacturers.

[/fusion_li_item][fusion_li_item icon=”fa-address-book fas” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

📖 Navigating the Complex CMC Landscape of ATMPs and CGTs – Understand the key challenges and strategies for Chemistry, Manufacturing, and Controls (CMC) in ATMP and CGT development.

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Are you seeking assistance with a regulatory compliance need?

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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

Where

Online Webinar

When

March 12, 2025 | 10:00 AM ET

What You Will Learn

  • Key ATMP regulatory requirements in the US & EU
  • Addressing common challenges in cell & gene therapy compliance
  • Expert insights into literature reviews, clinical data, and dossier preparation
  • Actionable strategies for accelerating regulatory approvals

Webinar Speakers

speaker-profile

Principal SME & Head RA, Celegence

Maurice Bancsi

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.

speaker-profile

Regulatory Consultant,Silva Correia Regulatory Ltd

Kattia Lonsdale

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.

Who Should Watch?

  • Quality teams & compliance officers overseeing dossier preparation
  • Cell & gene therapy manufacturers seeking regulatory insights
  • Explore More on ATMP Regulatory Challenges

Authored By

Shilpam Rajput

More by Shilpam Rajput