CERSI Writing Competition Winners - Previous Years
First place: Mark Robberson, "An Empirical Analysis of Innovation in the Pharmaceutical Industry Drug Class: Implications for Regulatory Policy"
Second place: John Winnike, "Substantial Evidence of Effectiveness: Considering a More Dynamic Model for Approval of Drugs Addressing Serious Unmet Medical Need"
Third place: Jasmine Birlew, "The Financial Risks of Non-Compliant Medical Devices"
First place: Courtney Turiano, "Basis of Approval and Associated Development Attributes of Drugs Approved by the FDA"
Second place: Danielle Jateng, "A Cross-sectional Study of Geriatric Labeling for High Impact Medications Used by Older Americans"
Third place: Mitsi McHugh, "Clearly Misunderstood Rules of the Stem Cell Road"
First place: Dana Wiegand, "Clinical Development Strategies and Regulatory Outcomes of FDA Approved Biological License Applications- Therapeutic Domain Considerations"
Second place: Adria Tyndall, "Human Factors Studies in Biologic License Applications for Injectable Device-Biologic Combination Products"
Third place: Carrie Voycheck, "The Relationship Between Medical Device Recalls and the Volume of Medical Device Reports (MDRs) Submitted to FDA"
First place: Lin-Chau Chang, "The Utilization of Standardized MedDRA Queries in Marketing Applications and their Regulatory Reviews."
Second place: Renee Harrell, "The Regulatory Implications of Data-mining."
Third place: Kelly Waldman, "Challenges of Integrating REMS Elements into Pharmacy Systems."