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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.
Don’t miss this opportunity to enhance your regulatory skills and understanding.
📖 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.
📖 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.
Online Webinar
March 12, 2025 | 10:00 AM ET
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.
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.
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