DIA 2019
Presentations
Short Course: Basics of European Medical Device Regulation
Sunday, June 23 | 9:00am - 12:30pm, Room 2
Angela Stokes, Regulatory Consulting
Short Course: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management
Sunday, June 23 | 9:00am - 5:00pm, Room 8
Christy Mazzarisi, Danielle Metzger, Kinapse
Innovation Theater: Dialing In The Optimal FSP Solution
Monday, June 24 | 5:30pm - 6:00pm
Eleanore Doyle, FSP Strategic Solutions
Shaun Williams, Investigator Management Solutions
To Err is Human: Progress & Challenges in the Prevention of Medication Errors
Tuesday, June 25 | 8:00am - 9:15am, Room 6C
Tony Catka, Addison Whitney
Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational and Patient Enrollment Challenges
Tuesday, June 25 | 8:00am - 9:15am, Room 6E
Esther Mahillo, Oncology and Hematology
Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Tuesday, June 25 | 10:30am - 11:30am, Room 11A
Sherry Merrifield, Global Operations
Methods for Integrating EHR Data into EDC and eSource Databases
Wednesday, June 26 | 8:00am - 9:15am, Room 1AB
Gene Vinson, Data Technologies, Biometrics
Medical Devices: EU Medical Device Regulation and US MDUFA IV – Where Are We Now?
Wednesday, June 26 | 8:00am - 9:15am, Room 6F
Angela Stokes, Regulatory Consulting
Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
Wednesday, June 26 | 10:30am - 11:30am, Room 2
Beatrice Setnik, Early Phase
Effective Portfolio Management of Assets Across an Organization
Wednesday, June 26 | 2:00pm - 3:15pm, Room 15AB
Kirsten Dawson, Addison Whitney
Content Hub: Success in the Workplace: What Does That Mean and How Can You Achieve it?
Wednesday, June 26 | 2:00pm - 3:15pm, Sails Pavilion
Vidhi Vashisht, Kinapse
Real World Data Quality for Regulatory Decision-Making
Wednesday, June 26 | 4:15pm - 5:30pm, Room 1AB
David Thompson, Real World and Late Phase
Posters - June 26th | 9:00AM - 4:00PM, Exhibit Hall A
Using a Continuous Learning Risk Repository System to Drive Efficiencies in Identification of Clinical Protocol Risk Patterns
Thaddeus Urban, Senior Clinical Data Manager
Clinical Trials and Clinical Operations Track
Reducing the Cost of Systematic Risk Assessments of Medical Products by Using a Modular Learning Risk Repository System
Stephen Sun, VP Head of Quality Risk Management
Clinical Safety and Pharmacovigilance Track
