Presenters
Margaret Zorn, MBA, MS
Senior Information Scientist, Instem, United States
Ms. Peggy Zorn is the Associate Director of Regulatory Operations, Submissions, and Transparency at MMS, with over 20 years of experience in regulatory affairs, drug safety, scientific information resources and IT. She is responsible for the management and oversight of all regulatory operations and clinical trial transparency services including all electronic publishing/submissions, clinical trial disclosures, clinical document redaction and patient lay summaries. Previously, Ms. Zorn was a Regulatory Submissions Lead and Associate Director of Worldwide Regulatory Affairs at Pfizer. Ms. Zorn holds a MBA and MS, and also earned a Regulatory Affairs Essentials Certificate from the University of California.
Kasim McLain
Manager, Clinical Trial Disclosure & Transparency, Incyte Corporation, United States
Kasim is the Manager of Disclosure Services at MMS Holdings. She has over 15 years of experience in regulatory affairs, medical writing, and clinical disclosures, with 8 of those years spent specifically in disclosures at both sponsor companies and contract research organizations. Kasim also holds a Regulatory Affairs Certification.
Gitta Irmer, MSc
Associate Director, Eisai Ltd, United Kingdom
Gitta Irmer, Associate Director Data Quality and Standards, Eisai Global Regulatory Operations; responsible for all study protocol registration and results disclosure to national databases. In 23 years of employment in the pharmaceutical industry, responsibilities have included a variety of roles in regulatory affairs and regulatory operations, ranging from regulatory affiliate through EU regulatory lead to publisher and various management roles. Working group memberships include the PhRMA Clinical Trial Data Transparency group and the DIA Disclosure Community.
Zach Weingarden, MS
Director, Product Solutions, TrialAssure, United States
Zach Weingarden is a Product Solutions Manager in Project and Account Management with over eight years of project management experience, currently leading the design and implementation of the TrialAssure Disclosure Management System. He has experience across a wide range of sponsors focusing in all areas of clinical trial transparency, including registry disclosure, plain language summaries, document redaction, and data anonymization. Mr. Weingarden holds a Master of Science in Biomedical Engineering, concentrating in Biotechnology, and a Bachelor of Science in Industrial and Operations Engineering from the University of Michigan.
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