DIA Annual Meeting - Drug Information Association
Monday, June 25
11:00 a.m. – 12:00pm
Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity
Panelist: Gene Vinson, Biometrics
3:00 pm – 4:15 pm
Evolving US Biosimilars Landscape – A Medical Affairs Perspective
Session Chair: Bryan Katz, Consulting
7:00pm - 10:00pm | 270 Northern Ave.
Site Appreciation Reception
Click Here to register and confirm your attendance.
Tuesday, June 26
8:00am – 9:00 am
Oversight in the Era of E6 (R2)
Speaker: Melissa Bomben, Strategic Resourcing *Session Chair
8:00am – 9:15 am
Global Regulatory Strategies for Biosimilars
Speaker: Brittany Scott, Addison Whitney - “The Evolving Regulatory Guidelines for Biosimilars and Biologics”
10:30am – 11:45am
The European Medical Devices Regulation and MDUFA IV – one year on; Is it any clearer
Speaker: Angela Stokes, Consulting *Session Chair
4:00pm - 5:15pm
Redefining the Site Investigator's Experience Forum
Speaker: Earl Seltzer, Site and Patient Access – “Bullseye! Hitting the Mark From Long Distance: Partnering With Sites to Better Plan for Study Conduct in Feasibility”
Wednesday, June 27
10:30am - 11:30am
Balancing Regulatory, Medical and Operational Pillars to Get Pediatric Trials Done Globally Forum
Speaker: Earl Seltzer, Site and Patient Access *Session Chair
1:00pm - 2:00pm | DIA Community Zone, North East Lobby, BCEC
Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines
The roundtable discussion will be based on a session that is occurring at 8:00 am titled: Evolution and Harmonization of First-in-Human Guidelines. Participants are encouraged to attend this 8 am session in order to discuss further at the roundtable at 1 pm. Click Here to learn more.
Speaker: Beatrice Setnik, Clinical Pharmacology, Early Phase
2:15pm - 2:45pm | Content Hub NE Lobby
First-In-Human Studies: An Examination of the Evolving Regulatory and Clinical Practices to Ensure Subject Safety
Speaker: Beatrice Setnik, Clinical Pharmacology, Early Phase
4:00pm - 5:15pm
Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making
Speaker: David Thompson, Real World and Late Phase - “Pragmatic Clinical Trials: The Future is Now”
Thursday, June 28
9:00am – 10:15am
Improving Efficiency and Effectiveness in Data Management of Oncology Studies
Speaker: Vijayalakshmi Angaiyan, Clinical Data Management - “Improving Efficiency and Effectiveness in Data Management of Oncology Studies”
