PLEASE NOTE: This program is a work in progress and subject to change.

Agenda

7:00 AM - 8:00 AM
Breakfast
7:00 AM - 5:00 PM
Registration
8:00 AM - 10:30 AM
Good Clinical Practice (GCP): Part 1
Drug Development 101
Dissecting a Clinical Trial Agreement Part 1
10:45 AM - 1:15 PM
Good Clinical Practice (GCP): Part 2
Basic Clinical Trial Designs and Concepts
Dissecting a Clinical Trial Agreement Part 2
Foundation Course: Billing Compliance
1:15 PM - 2:30 PM
Boxed Lunch
2:30 PM - 4:00 PM
Participant Recruitment: Innovations and Best Practices
Professional Skills 101
Drug Development 101
Master Course: Billing Compliance
4:00 PM - 6:00 PM
Opening Reception
7:00 AM - 8:00 AM
Breakfast
7:00 AM - 5:00 PM
Registration
8:00 AM - 8:15 AM
Opening Remarks
8:15 AM - 9:30 AM
Keynote: The Importance of Clinical Research: A Patient’s Perspective
9:30 AM - 10:00 AM
Networking Break
10:00 AM - 10:45 AM
Contract Breakout: Creating and Using a Clinical Trial Agreement (CTA) Playbook
Site and Sponsor Relationships Breakout
Research Ethics and IRBs Breakout: Best Practices in Participant Payment
Medical Devices 101 Breakout
Study Billing Breakout: Intro to Medicare Coverage Analysis
10:45 AM - 11:30 AM
Contract Breakout: Deal Breaker Terms in Clinical Trial Agreements (CTA)
Site and Sponsor Relationships Breakout
Research Ethics and IRBs Breakout: The Role of Data Safety Monitoring Boards
Medical Devices 101 Breakout
Study Billing Breakout: Billing Compliance and Reimbursement for Device Trials
11:30 AM - 12:15 PM
Contract Breakout: TBD
Site and Sponsor Relationships Breakout
Research Ethics and IRBs Breakout: When Employees Are Study Participants
Medical Devices 101 Breakout
Study Billing Breakout: Medicare Coverage Analysis Out of the Ordinary
12:15 PM - 1:00 PM
Lunch in the MAGI Cafe: Birds of a Feather
1:00 PM - 2:00 PM
Dessert in the MAGI Lounge
2:00 PM - 2:45 PM
Contract Breakout: Indemnification
Data Privacy and General Data Protection Regulation (GDPR) Breakout
Research Ethics and IRBs Breakout: The Difference between Compliance and Ethics
Investigator Initiated Trials
Study Billing Breakout: Billing Audits and Monitoring
Issues in Pediatric Research
2:45 PM - 3:30 PM
Contract Breakout: Subject Injury: Contracting and Billing Considerations
Data Privacy and General Data Protection Regulation (GDPR) Breakout
Research Ethics and IRBs Breakout: The role of the IRB in Ensuring Diversity in Research
Investigator Initiated Trials
Study Billing Breakout: Panel Discussion: Operationalizing Your Research Billing Compliance Plan
Issues in Pediatric Research
3:30 PM - 4:00 PM
Networking Break
4:00 PM - 5:15 PM
Solving the Challenges of Decentralized Clinical Trials (DCTs)
5:15 PM - 6:30 PM
Networking Reception and Book Signing
7:00 AM - 8:00 AM
Breakfast
7:00 AM - 5:00 PM
Registration
8:00 AM - 8:15 AM
Welcome Remarks
8:15 AM - 9:30 AM
Ensuring Appropriate Representation in Clinical Trials to Advance Medicine and Reduce Health Disparities
9:30 AM - 10:00 AM
Networking Break
10:00 AM - 10:45 AM
Clinical Research Physicians Breakout
Site Management Breakout: Employee Retention and Motivation
Study Budgets Breakout: Budget Development and Negotiations for Sites
Recruiting Study Participants Breakout
Special Issues in Oncology Clinical Trials
Gene Therapy Breakout: Gene Therapy 101
10:45 AM - 11:30 AM
Clinical Research Physicians Breakout
Site Management Breakout: Right-sizing your SOPs
Study Budgets Breakout: Hidden Costs for Sites and Sponsors
Recruiting Study Participants Breakout
Special Issues in Oncology Clinical Trials
Gene Therapy Breakout: Unique Risks and Considerations in Gene Therapy Research
11:30 AM - 12:15 PM
Clinical Research Physicians Breakout
Site Management Breakout: How Research Operations and Compliance Can Work Together
Study Budgets Breakout: Fair Market Value (FMV) in Industry-Sponsored Trial Budgets
Recruiting Study Participants Breakout
Special Issues in Oncology Clinical Trials
Gene Therapy Breakout: Unique Ethical and Operational Issues in Gene Therapy Research
12:15 PM - 1:00 PM
Lunch in the MAGI Cafe: Regions
1:00 PM - 2:00 PM
Dessert in the MAGI Lounge
2:00 PM - 3:30 PM
Debate: Clinical Trials “as a Care Option”: a Pro/Con
Best Practices for Incorporating Patient Feedback Into Drug Development Programs
3:30 PM - 4:00 PM
Networking Break
4:00 PM - 5:15 PM
Technology in Clinical Trials
7:30 AM - 8:30 AM
Breakfast
7:30 AM - 10:00 AM
Registration
8:30 AM - 10:00 AM
Site Innovation Forum
10:00 AM - 10:30 AM
Networking Break
10:30 AM - 12:30 PM
Networking Session for Biopharma Executives (Invite Only)
Hot Topic Breakout
Avoca Quality Consortium Roundtable

Exhibit Hall Hours

Sunday, October 16, 2022
4:00 PM - 6:00 PM
Monday, October 17, 2022
9:00 AM - 6:30 PM
Tuesday, October 18, 2022
9:00 AM - 3:00 PM