Taking Advantage of the EU MDR Delay in Uncertain Times – Webinar
Overview
Where
Online
When
10.00 AM EST
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.
What You Will Learn
This webinar is ideal for professionals working in regulatory affairs and quality assurance within the ATMP pharmaceutical sector, including:
- 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
Webinar Speakers
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.
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.
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.
Authored By
Celegence Admin
Where
Online
When
10.00 AM EST
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25 Apr, 2025
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