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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.
Tuesday, April 10 • 10:30am - 12:00pm
Morning Plenary

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FDA BIMO Update (45 minutes) - Chrissy Cochran
Pre-approval Inspections, GMP Regulations and Data Integrity (45 minutes) Dr. Krishna Ghosh
Moderators
avatar for Beth Moulaison

Beth Moulaison

Vertex
Beth Moulaison joined Vertex in 2016 and is currently the Director of R&D Quality Assurance overseeing nonclinical and clinical activities conducted in compliance with industry standards and regulations. Prior to joining Vertex, Beth worked for Shire (2012-2016) while employed there... Read More →

Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

FDA
Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She has extensive experience... Read More →

Tuesday April 10, 2018 10:30am - 12:00pm
Platinum 5&6
  Plenary

Attendees (169)