Christine Sweeney, PhD, MPH
Director, Issues Management
Establishing the data driven benefit-risk case to support regulatory approval of consumer healthcare products
Expertise
Christine helps clients meet their regulatory and commercial goals by utilizing data available in the published literature and proprietary and public data sources to identify and address the issues raised by FDA and other stakeholders during the drug review process.
She focuses on:
- Issues identification and management
- Benefit-risk assessments and public health rationales
- OTC product labeling
- Label comprehension, self-selection, human factors, and actual use studies
- Literature reviews and analyses
- Regulatory submissions
- Advisory committee preparation
Experience
Since joining Pinney Associates in 2000, Christine has supported a wide range of Rx and OTC efforts in therapeutic areas that include contraceptives; men’s health; and treatments for allergic rhinitis, elevated cholesterol, obesity, pain, and smoking cessation. She has authored or co-authored papers published in such peer-reviewed journals as CNS Drugs; Tobacco Control; and Pharmacology Biochemistry and Behavior.
Education
- Post-doctoral fellowship, Cancer Prevention, National Cancer Institute
- MPH, Epidemiology, Johns Hopkins University
- PhD, Biobehavioral Health, Penn State University
- BA, Psychology, LaSalle University