FDA Updates Recognized Consensus Standards Database with List 61
Online Webinar
March 12, 2025 | 10:00 AM ET
Benefit-risk analysis is a cornerstone of compliance for medical device manufacturers under the EU MDR. This rigorous process evaluates whether the benefits of a device outweigh its associated risks, ensuring patient safety and regulatory approval. With the increasing complexity of medical devices and evolving regulations, understanding and implementing effective benefit-risk analysis is critical.
But what does it take to successfully navigate these complexities? In this blog, we delve into insights shared during a recent webinar to explore key methodologies, tools, and best practices to excel in this domain.
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.
This webinar is ideal for professionals working in regulatory affairs and quality assurance within the ATMP pharmaceutical sector, including:
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.
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.
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.
Chief Scientific Officer
Online Webinar
March 12, 2025 | 10:00 AM ET
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FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins)
15 DEC, 2023
FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins)
15 DEC, 2023
