PRESS RELEASE
15 September 2022

FDA Manufacturing Compliance And Inspections For Cell And Gene Therapies And Other Innovative Biologics

AP
Arnold & Porter

Contributor

Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
Cell and gene therapies provide tremendous hope to patients and their healthcare providers in curing and mitigating serious, often previously incurable, diseases and conditions.
United States

Thursday, September 15, 2022
1:00–2:00 PM ET
Arnold & Porter and Lachman Consultants

Register

Cell and gene therapies provide tremendous hope to patients and their healthcare providers in curing and mitigating serious, often previously incurable, diseases and conditions. Because these products are complex, novel, and derived from biological sources, the manufacture of these products creates unique challenges throughout product development and commercialization.

In this webinar, Arnold & Porter attorneys and experts from Lachman Consultants will discuss current GMP requirements, FDA inspections, manufacturing challenges, quality agreements, and other practical considerations for cell and gene therapy products. Our speakers will address these matters, from product development through commercialization, and highlight real-world scenarios and best practices based on their experience. They will also cover challenges, concepts, and approaches to compliant manufacture of other novel biopharmaceuticals.

Speakers

Howard Sklamberg, Partner, Life Sciences and Healthcare Regulatory, Arnold & Porter

Phillip V. DeFedele, Senior Associate, Life Sciences and Healthcare Regulatory, Arnold & Porter

John McShane, Vice President, Biologics and Manufacturing Data Integrity, Lachman Consultant Services, Inc.

Keith A. Lamb, Executive Director, Lachman Consultant Services, Inc.

PRESS RELEASE
15 September 2022

FDA Manufacturing Compliance And Inspections For Cell And Gene Therapies And Other Innovative Biologics

United States

Contributor

Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
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