[
Webinar
|
August 16, 2022
]

Accelerating QbD: Perspectives on Leveraging ICH and Digitization for Success

Perspectives on Leveraging ICH and Digitization for Success

A 60-minute panel of cross-industry experts will share their unique perspectives on implementing Quality-by-Design (QbD), specifically how to use the quality target product profile (QTPP) as the foundation for designing quality into your product.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply the ICH guidelines based on real-world experiences resulting in more complete and comprehensive submissions.

Speakers
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[
Chief Business Officer
]

Malia Lewin

[
Principal Engineer
]

Mark Mitchell

[
Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence
]

Greg Troiano

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

[
Director of Regulatory Compliance
]

Stephanie Gaulding

[
President & CEO
]

Yash Sabharwal

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.