April 4-5, 2022
Online Livestream
2nd Risk Based Quality ManagementSummit
Transform Clinical Quality Through a Compliant & Robust Risk-Based Approach
Days
Hours
Minutes
Seconds
A risk-based approach to clinical trials can help you quickly reduce trial complexity and costs while getting the most out of your R&D budget. Best practices in RBQM are influencing clinical study methodology and decentralized trials, putting a spotlight on risk based data review including site and central monitoring.
The 2nd Risk-Based Quality Management Summit helps you establish cross-functional risk-management teams to oversee your clinical trials, cutting down risks and accelerating drug development.
Top Reasons to Attend
- Sharpen skills for risk identification, mitigation and response
- Examine challenges to vendor oversight— how to define it and how to manage it
- Evaluate risks involved in virtual trials
- Spotlight benefits of AI and ML for curating unstructured data
- Examine data literacy as the change agent to deliver study wide insights
- Understand how to plan and implement QTLs for ICH E6 (R2) compliance
- Address lessons learned from change management initiative
- Understand how to minimize the chance of a failed clinical trial
- Share insights on K-97-1 and the FDA's ``Decision Tree``
Who Should Attend
This conference is designed for pharmaceutical, biotech, and medical device professionals responsible for:
- RBM/RBQM
- Study Monitoring
- Central Monitoring/Site Monitoring
- Clinical Operations
- Clinical Research
- Clinical Quality
- Clinical Quality Assurance
- Clinical Compliance
- Clinical Outsourcing
- Data Management
- Data Science
- Global Clinical Trial Operations
- Regulatory Affairs
- Risk Evaluation
- Risk Management
- Adaptive Integrated Monitoring
- Clinical Quality Oversight
- Clinical Trials
- Development Sciences Quality
- Field Management
- Inspection Readiness
- Program Operations
- Risk & Strategic Monitoring
- Site Management
- Vendor Oversight and Governance
Event Sponsors
Event Association Partners
Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
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