DIA年次総会－（Drug Information Association：医薬品情報協会）

Monday, June 25

11:00 午前 – 12:00午後

Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity

Panelist: Gene Vinson, Biometrics

3:00 午後 – 4:15 午後

Evolving US Biosimilars Landscape – A Medical Affairs Perspective

Session Chair: Bryan Katz, Consulting 

7:00午後 - 10:00午後 | 270 Northern Ave.

Site Appreciation Reception 

Click Here to register and confirm your attendance. 

Tuesday, June 26

8:00午前 – 9:00 午前

Oversight in the Era of E6 (R2)

Speaker: Melissa Bomben, Strategic Resourcing *Session Chair

8:00午前 – 9:15 午前

Global Regulatory Strategies for Biosimilars

Speaker: Brittany Scott, Addison Whitney - “The Evolving Regulatory Guidelines for Biosimilars and Biologics”

10:30午前 – 11:45午前

The European Medical Devices Regulation and MDUFA IV – one year on; Is it any clearer

Speaker: Angela Stokes, Consulting *Session Chair

4:00午後 - 5:15午後

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

10:30午前 - 11:30午前

Balancing Regulatory, Medical and Operational Pillars to Get Pediatric Trials Done Globally Forum

Speaker: Earl Seltzer, Site and Patient Access *Session Chair

1:00午後 - 2:00午後 | 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 午前 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

2:15午後 - 2:45午後 | 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

4:00午後 - 5:15午後

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

9:00午前 – 10:15午前

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”