Agenda at a Glance
Day One
Wednesday, February 24, 2021
All Times in Eastern Standard Time
9:45 am EST
Opening Remarks
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

10:15 am EST
Risk-Based Approach for Document Management
10:45 am EST
Innovative Use of eTMF/ Technology With a CRO (Read More)
- what is risk?
- A risk-based approach: benefits
- Risk based approach for quality in documentation
- A risk based approach for implementing eTMF
11:15 am EST
Networking Break in the Lounge
11:45 am EST
Maintaining a Quality & Compliant TMF Foundation to Ensure a Successful CRO / Sponsor Relationship (Read More)
- Establishing a robust TMF Foundation to support the CRO / Sponsor Relationship.
- Review of practical engagement tools for quality and transparent oversight
- Use of shared metrics to monitor the process and deliverables to support continual improvement
12:30 pm EST
Panel
Successful Sponsor, CRO, and Site Collaboration (Read More)
- Impact of a governance structure that incorporates metrics and monitoring
- Review of technology and impact of oversight with data
- Practical usage of your eTMF for monitoring to ensure inspection readiness
- Best practices and resources need to ensure a compliant and high performing collaboration
1:15 pm EST
Networking Break in the Lounge (Read More)
- Impact of your current RBM process and redefining it to strategically ensure trial success
- Developing a successfully RBM strategy for sites and CROs
- Impact on a paperless trial
- Reporting on KPIs and quality metrics
1:45 pm EST
Redefining Risk-Based Monitoring to Impact your Global Trials
2:15 pm EST
Moving the Needle: Standardized Technical Workflows for Digitalizing Documentation Processes (Read More)
- Overview of defining a GCP framework
- Review of ICH GCP R2
- Utilize your framework to increase oversight and inspection readiness
Director, Communities & Opportunities Development; Healthcare Life Sciences Practice Leader
IEEE-Standards Association

2:45 pm EST
Networking Break in the Lounge
3:15 pm EST
Day One Concludes
Day Two
Thursday, February 25, 2021
9:45 am EST
Opening Remarks
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

10:00 am EST
SaaS eTMF System Validation… Is this Really Necessary?
10:45 am EST
Align SOPs and your eTMF to Ensure Completeness
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

11:15 am EST
Networking Break in the Lounge
11:45 am EST
Panel
Leveraging Partnerships to Ensure your TMF is Inspection Prepared
12:30 pm EST
Panel
Leveraging Emerging Technologies (Read More)
- Overview on emerging technologies and the next generation of eTMFs
- Review of AI impact
- Improve quality through technology
- Practical considerations for eTMF System Implementation
Associate Director, TMF Operations Clinical Systems & Records Global Clinical Operations & Planning
Daiichi Sankyo

1:30 pm EST
Networking Break in the Lounge
2:15 pm EST
CRO, Sponsor, Site Process Alignment to Enhance TMF Management (Read More)
- Utilize the TMF management plan to guide deliverables and oversight
- Ensure SOPs align with technology
- Review the eTMF oversight and management plan and sampling eTMF for QC
eTMF SME
3:15 pm EST
Networking Break in the Lounge
3:45 pm EST
Day Two Concludes
Day Three
Friday, February 26, 2021
9:30 am EST
Opening Remarks
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

9:45 am EST
Improving Quality by Identifying Common Issues with TMF Process and System (Read More)
- Reviewing MHRA inspection findings over a four year period
- Impact and potential causes of these finding
- Utilizing past findings to improve Quality within your TMF process
10:15 am EST
Identify Quality Trends and Optimize Operations to Impact Documentation (Read More)
- Describe the role of continuous improvement in management of documentation/Trial Master File
- Develop Key Quality Indicators to identify issues early
- Explain how to optimize your operations through evaluation of Key Quality Indicator trends
10:45 am EST
Supporting an Audit With Limited Resources (Read More)
- Identifying needs vs wants
- Getting the most out of your resources
- Targeting pain points
11:15 am EST
Networking Break in the Lounge
11:45 am EST
TMF Validations and Oversight to Ensure Data Integrity (Read More)
- Develop a proper data integrity checklist
- Review key principles of data integrity and ensure a audit trail and validations
12:15 pm EST
Preparing for an Inspection by Designing and Running Mock Inspections (Read More)
- Identify all critical aspects of an inspection to ensure your team is prepared
- Review of quality responsibilities
- Preparing and presenting critical documentation
- Look back at mock inspection results to prepare for your inspection
12:45 pm EST
Panel
Ensure Clinical Quality for all Trial Documents (Read More)
- Overview of the role a site, CRO, and sponsor has on quality
- Impact of a clinical quality management system impact on process, procedures, and responsibilities
- Creating a quality culture and its impact on inspection readiness
TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca

1:45 pm EST
Networking Break in the Virtual Lounge
2:15 pm EST
Summit Concludes