How to Communicate Complex Information to Management and Regulatory Agencies

Includes a Live Web Event on 05/13/2025 at 12:00 PM (EDT)

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An important skill for quantitative scientists within the pharmaceutical industry is the need effectively communicate complex technical information. This is especially challenging when the audience includes high-level stakeholders such as senior managers and regulatory representatives who may not have a deep technical understanding but must rely on modeling and simulation analyses to drive decision making. In this webinar, important points to consider will be discussed that can help attendees develop and deliver successful presentations that are tailored to meet the needs of the target audience and their objectives.

Ginny Schmith

Virginia (Ginny) Schmith has 35+ years of experience in clinical pharmacology and pharmacometrics providing strategy across all phases of drug development and numerous therapeutic areas: anesthesia, cardiovascular, pulmonary, gastrointestinal, central nervous system, dermatology, cancer, inflammation, antibiotics, antivirals, and rare diseases, and has actively contributed to the approval of 15+ drugs. She worked for GSK (and predecessor companies) for 26 years and then went into consulting at Nuventra Pharma Sciences for almost 7 years. Currently, she continues to consult with small companies within her own company (Schmith PK/PD Consulting LLC) and as part of the Syntegrity Quantitative Clinical Pharmacology Collaborative.

Ginny’s focus is on the strategy for using quantitative clinical pharmacology approaches to answer drug development questions, even when there is incomplete data, and communicating (written and orally) this information to regulatory agencies and management within small biotechnology companies.

Dr. Schmith has been an Adjunct Professor at UNC-CH Eshelman School of Pharmacy since 1989 and recently become a Courtesy Clinical Professor at the University of Florida School of Pharmacy. Ginny has published 50 peer-reviewed articles and reviews in international scientific journals in addition to over 80 published abstracts related to clinical pharmacology and pharmacometrics; she has authored 6 patents; and is an active member of the American Society of Clinical Pharmacology (since 1989), the International Society of Pharmacometrics, and a fellow of the American College of Clinical Pharmacology.