2008 Cohort

Dr. Susan Bain“Regulatory” Due Diligence: A Survey Investigation of Best Practices in the Medical Products Industry
Dr. Tony ChanImplementation of Risk Management in Medical Device Companies: A Survey Analysis of Current Practices
Dr. Grant DagliyanImplementation of Good Manufacturing Practice Regulations for Positron Emission Tomography Radiopharmaceuticals: Challenges and Opportunities Perceived by Imaging Thought Leaders
Dr. Michael JamiesonThe Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views
Dr. William LeitnerFDA Influence on Advisory Committees through Documentation: A Content Analysis and Survey of Industry Views
Dr. Duane MauzeyCurrent Practices in Pharmaceutical Container Closure Development
Dr. JoAnn PfeifferCurrent Practices of U.S. Investigators in the Management of the Clinical Trial Agreement: A Survey of Knowledge, Attitudes, Perceptions, and Engagement.
Dr. Taranjit Singh SamraSoftware Risk Management: An Exploration of Software Life Cycle Methodologies, Best Practices and Tools for their Application to Medical Device Software Risk Management
Dr. Martin SolbergA Survey Analysis of Transparency in Three Asian Regulatory Agencies Responsible for Medical Products
Dr. Ellen WhalenClinical Trials Driven by Investigator-Sponsors: GCP Compliance With or Without Previous Industry Sponsorship

2010 Cohort

Lilit AladadyanImplementation of Tobacco Regulatory Science Competencies in the Tobacco Centers of Regulatory Science (TCORS): Stakeholder Views.
Dr. Kwabena DankwahPromotion of Regulated Products Using Social Media: An Industry View
Dr. Patrick DimapindanAn Integrated Framework to Evaluate Customer Service Delivery: A Study of Electronic Systems at FDA’s Los Angeles Import Operations Branch
Dr. Clare ElserValidation Master Plans: Progress of Implementation within the Pharmaceutical Industry
Dr. David LockeReprocessing of Single-use Medical Devices: A Survey Investigation Comparing the Views of Three Unheard Stakeholders
Dr. Richard McCallRisk Approaches and Standards Used in Hospitals: A Survey of Industry Views
Dr. Susan RamseyThe Impact of Incomplete Monographs on the OTC Drug Industry: A Survey Investigation of Industry Views
Dr. Chin-Wei SooConvergence of United States Regulatory and Reimbursement Policies Impacting Patient Access to Humanitarian Use Devices (HUD)
Dr. Neal StormRegulatory Dissonance in the Global Development of Drug Therapies: A Case Study of Drug Development in Postmenopausal Osteoporosis
Dr. Simone TurnbullRegulating Cosmeceuticals in the United States: A Cosmetic Industry View

2012 Cohort

Dr. Donatus Ako-ArreyEffect of GDUFA Legislation on the Development and Approval of Generic Drugs: A Survey of Industry Views and Experiences
Dr. Terry ChurchContinuity Management in Biobank Operations: A Survey of Biobank Professionals
Dr. Alicia M. McDowellChallenges in the Implementation of Risk Evaluation Mitigation Strategies (REMS): A Survey of Industry Views
Dr. Aimee GrecoImplementation of Unique Device Identification in the Medical Device Industry: A Survey of the Change Management Experience
Dr. Grant GriffinSharing the Results Of Clinical Trials: Industry Views On Disclosure Of Data From Industry-Sponsored Clinical Research
Dr. Martha KamrowOrganizational Communication of Regulatory Intelligence: A Survey of the Medical Device Industry
Dr. Cesar MedinaIncentivizing Quality in the Manufacture of Pharmaceuticals: Manufacturers’ Views on Quality Ratings
Dr. Caroline MosessianValue Based Purchasing: Decision-Making Processes Underlying Hospital Acquisitions of Orthopedic Devices
Vada PerkinsIndustry Views on IDMP Implementation
Dr. Nancy Pire-SmerkanichBenefits-Risks Frameworks: Implementation by Industry
Dr. Susan PusekIRB Capabilities to Oversee New Technology: Social Media as a Case Study
Dr. Ali RejaeiEstablishing Clinical Efficacy of Botanical Products: A Survey of Industry Views
Dr. Catherine SheehanViews on Global Harmonization of Pharmacopeial Standards: A Survey of Key Stakeholders
Dr. Alexa SmithUse of Natural Colors: Experience and Views in Pharmaceutical and Dietary Supplement Industries

2014 Cohort

Dr. Sunita Babbar Challenges to Implementation of Alternative Methods to Animal Testing for Drug Safety Assessment in North America
Dr. Victor GangiExamining the Regulatory Framework for Drug Compounding: Industry Views and Experiences
Dr. John HartiganComputerized Simulation in Clinical Trials: A Survey Analysis of Industry Progress
Michelle McGuinness Investigating in Orphan Drug Development: An Analysis of the Impact of Orphan Drug Incentive Programs in the United States
Dr. Nami MigitaRegulatory Programs to Foster Medical Product Development: User Experience in the United States and Japan
Dr. Penny NgRegulation of Pediatric Cancer Drug Development: An Industry Perspective
Raina OlexaReal World Evidence for Regulatory Decision Making
Dr. Darin OppenheimerRisk Management and Recalls: A Survey of Medical Device Manufacturers
Dr. Katherine St. MartinExamining the Cord Blood Industry Views on the Biologic License Application Regulatory Framework
Dr. Curtis TruesdaleRegulatory Team Development in Post-Merger Integration: A Survey of Views from Medical Product Companies
James TurnerIT /RA linkages
Dr. Jennifer WileyExperience with Breakthrough Therapy Designation: An Industry Survey

2016 Cohort

Monique CarterGlobal  Expedited Regulatory Drug Development Pathway Utilization and Impact
Dr. Jeanne GreenwaldU.S. Veterinary Drug Shortages: Industry Views on Potential Changes to Regulatory Policy
Virginia HillSubstantiating Structure Function Claims
Terence HoganSustaining Clinical Trial Transparency While Preventing the Re-Identification of Subjects
Martinus Koning-BastiaanInstitutional review board implementation of the single IRB model for multicenter clinical trials
Laura KupschInter-IRB transparency
Dr. Wendi LauA Survey of US Industry Views on Implementation of Decentralized Clinical Trials
Geoffrey OkeloExploring Critical Elements of First Time Approval:  Generic Tool for Effective High-Quality ANDA Submission
Dr. Mary WilhelmRegulatory Agreements for Drug Development Collaborations: Practices in the Medical Products Industry
Dr. Carolyn WrightUsing Telemetry to Ensure Safe and Reliable Medical Device Operation: Experience with Defibrillators and Infusion Pumps
Michael YartzoffCurrent practices in biocompatibility assessment of medical devices

2018 Cohort

Dr. Lori AlquierRegulatory Harmonization in a Resource-Limited Setting: The World Health Organization Collaborative Procedure for Accelerated Registration
Mladen Bozic
Wendy Clark
Kerry Cobb
Wenying Du
Cheryl Hergert
Ronald Lillie
Hai Luong
Dr. Lequina MylesAn Industry Survey of Implementation Strategies for Clinical Supply Chain Management of Cell and Gene Therapies
Nozomi Yagi

2020 Cohort

Eugene Babcock
Lisa Crockett
Mary Ann Del Fiorentino
Brian Green
Anjali MalhotraImplementation of validated electronic records and signatures: a survey of industry approaches 
Sonali Namiranian
Tayler Renshaw
Katy Rudnick
Bridget Walton
Colleen Watson