Discover Key Regulatory Insights for Advanced Therapy Medicinal Products (ATMP) Success
Webinar Overview
Bringing an Advanced Therapy Medicinal Product (ATMP) to market—whether cell-based therapies, gene therapies, or combined ATMPs—requires scientific expertise, strategic compliance approaches, and a deep understanding of evolving EU and US regulations. With increasing scrutiny from regulatory agencies, pharmaceutical companies must ensure regulatory alignment, scientific rigor, and compliance excellence throughout the product lifecycle.
Join Celegence’s exclusive webinar on March 12, 2025, where industry experts will provide actionable insights on overcoming regulatory hurdles, understanding key guidelines, and streamlining the approvals process. This session will equip attendees with practical knowledge to enhance regulatory preparedness and mitigate risks in ATMP development.
What You Will Learn
- Key Regulatory Requirements: Overview of the evolving EU and US regulatory frameworks for ATMPs.
- Challenges in ATMP Development: Understanding the complexities in regulatory approval pathways for gene therapies, cell-based therapies, and combined ATMPs.
- Best Practices for Regulatory Compliance: Strategies to optimize scientific documentation and meet regulatory expectations efficiently.
- Navigating Market-Specific Regulations: Practical approaches to aligning with EMA and FDA requirements for streamlined market entry.
Who Should Attend?
This webinar is ideal for professionals working in regulatory affairs and quality assurance within the ATMP pharmaceutical sector, including:
- Regulatory professionals new to ATMP regulatory requirements.
- Regulatory Affairs Directors, Quality Assurance Directors, and decision-makers seeking a regulatory compliance refresher.
- Experts managing cell and gene therapy product approvals, looking to stay ahead of evolving regulations.
Meet the Experts
- Maurice Bancsi, Principal SME & Head RA, Celegence
Maurice is Celegence’s Principal Subject Matter Expert and Head of Pharmaceutical Regulatory Affairs. He has over 28 years’ experience in the pharmaceutical and biotech industry, mainly supporting pre-approval drugs and biologics for oncology, pulmonary, and cardiovascular indications. His expertise includes regulatory strategy development, health authority interactions, regulatory intelligence, and applications such as MAAs, CTAs, EU & US Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports, and DSURs. - Kattia Lonsdale, Regulatory Consultant, Silva Correia Regulatory Ltd
Kattia is an independent regulatory consultant specializing in gene and cell therapy products. With over 13 years of regulatory experience, she has focused on gene/cell therapy projects for the last 6 years. Her expertise spans early phase to post-authorisation maintenance across global markets, including the USA, LATAM, and Europe. Kattia holds an MSc in Analytical Chemistry and has over 16 years of experience in science-based roles.
Stay Ahead of Regulatory Challenges – Register Now!
Whether you’re looking to refine your ATMP regulatory submission strategies, gain clarity on compliance expectations, or streamline market access, this session will provide invaluable guidance.
All registrants will receive a copy of the webinar recording after the live session.
Don’t miss this exclusive opportunity to gain expert insights into ATMP success.
