Webinar - Overcoming Regulatory Challenges for Cell & Gene Therapy Products: ATMP Success Insights

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.

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

Meet the Experts
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.

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

Don’t Miss These Critical Insights
Stay ahead of evolving regulatory requirements and ensure compliance for cell & gene therapy products with expert strategies from Celegence. For expert guidance, contact us at info@celegence.com.

Watch the webinar now and gain actionable insights into ATMP regulatory compliance.

Видео Webinar - Overcoming Regulatory Challenges for Cell & Gene Therapy Products: ATMP Success Insights канала Celegence