Agenda at a Glance
Pre-Conference Workshop
Monday, May 24, 2021
All Times in Eastern Standard Time
10:00 am EST
Pre-Conference Workshop Begins (Read More)
Key Areas to Adapt to when an Inspection is Conducted Remotely
Remotely conducted health authority inspections are currently necessitated due to the COVID-19 pandemic. However, components of remotely conducted inspections will remain embedded in the future inspection process well beyond the current situation. To ensure that your company is ready for a remote inspection, it must assess current inspection-related processes to be flexible to host one that is conducted all or partially remote. During this interactive workshop we will:
- Identify the areas of biggest change when some or all of an inspection is conducted remotely
- Identify core elements that will need to be changed when all or portions of an inspection is conducted remotely
- Review why the technology aspect of inspections is so much more important and how to support all of those involved
- Explore strategies for how to prepare your organization for the provision of content to be reviewed by remotely located inspectors
- Examine suggestions for preparing for virtually conducted inspection interviews
*This workshop contains a 30-minute break
2:00 pm EST
Pre-Conference Workshop Ends
Main Conference Day One
Tuesday, May 25, 2021
10:45 am EST
Opening Remarks
11:00 am EST
Keynote Panel
Combating the Forces that Prevent the TMF from Being Inspection-Ready: A Creative Look at How to Use TMF Tools to Identify and Prevent Common Issues from Occurring
11:30 am EST
Remote Inspection Best Practices: Be ready for FDA GCP Inspections during the Pandemic. (Read More)
- Overview of how major Health Authorities are adopting remote inspections
- Salient differences between Onsite and Remote inspections.
- The shift in inspection readiness preparation. Does and Don’ts: A practical perspective
12:00 pm EST
Networking Break in the Virtual Lounge
12:30 pm EST
Open Mic Q&A with the Experts (Read More)
Take advantage of this opportunity to ask Lisa and Donna any questions on your mind about Inspection Readiness.
1:00 pm EST
Case Study: Planning and Executing a Mock BIMO Inspection (Read More)
- Overview of the plan to put the team through a mock BIMO inspection including identifying a vendor to run the inspection
- Ensure all clinical, document, and quality teams are trained and on-board with the plan to execute the audit along with the site and CRO
- Overview of logistics and technology needed by all team members
- Review of front and backroom team etiquette
- Best practices and lessons learned from the mock inspection
1:30 pm EST
Utilizing Technology to Minimize Inspection Risk During M&A (Read More)
During this panel discussion you will learn about:
- The M&A Landscape
- TMF Challenges following M&A
- Real World Scenarios and Models
- Utilising AI
- Streamlining Quality Review
2:00 pm EST
Networking Break in the Virtual Lounge
2:30 pm EST
Case Study: Enhance your Remote Inspection through People, Process, and Technology (Read More)
- Impact of communication to all SMEs and inspection teams in order to prepare for a remote inspection
- Review FDA, EMA, and MHRA guidance for preparing for a remote GCP inspection
- Overview of the process and run a mock inspection to ensure a streamlined inspection
- Understand the technology that will be used and workout the logistics to ensure a seamless process
3:00 pm EST
Spotlight Session: Keys to Inspection Readiness (Read More)
- Identifying Critical to Quality Factors
- Using Quality Risk Management to Drive Overall Quality
- Ensuring Comprehensive Documentation to Support Submission
3:30 pm EST
Panel
Inspection Readiness through Proper Operation Management (Read More)
- Review your inspection management plan to ensure SME and other colleagues are prepared for the inspection
- Ensure your storyboard outlines the inspection process and properly tells the trial's story
- Anticipate all potential issues and ensure the team is prepared to speak to hot button issues
- Overview of managing the inspection process
4:00 pm EST
Day One Concludes
Main Conference Day Two
Wednesday, May 26, 2021
10:45 am EST
Opening Remarks
11:30 am EST
Indexing Documents Utilizing the TMF Reference Model to Ensure Inspection Readiness (Read More)
- Utilize the reference model as a foundation to ensure document indexing to Regeneron needs
- Ensure a complete document list
- Review documents to ensure the TMF is inspection ready
- Incorporate reference model updates
12:00 pm EST
Networking Break in the Virtual Lounge
12:30 pm EST
Spotlight Session: A Holistic Approach to Inspection Readiness (Read More)
When planning for a regulatory inspection, the ultimate goal is to be fully prepared. An inspector will leverage the TMF and interviews with study team members to put together a picture of the story of the study. In order to be fully prepared it is important that we understand the story of our study. This session will examine strategies for understanding the story of our study and the implications of the story’s alignment with organizational standards, study plans, and the TMF.
1:00 pm EST
Panel
Establishing a Culture of Inspection Readiness (Read More)
- Ensure that all stakeholders involved in clinical operations fully understands the importance of inspection readiness from an effective preparation level
- Impact of reducing time to prepare for an inspection
- Best practices for all teams and stakeholders to understand all SOPs and their impact to a trials inspection
- Setting the foundation and best practices to ensure a culture of inspection readiness
1:30 pm EST
Regulatory Documentation Management for a Remote Inspection (Read More)
- Determine Stakeholder Roles and Responsibilities
- Anticipate desired documentation for Inspectors
- What are the Requirements for providing documentation to Inspectors to satisfy both your organization and the Inspector
- Determine best method to provide Documentation to Inspectors
- Determine your Inspector Access Process according to your organization’s current process and technology
2:00 pm EST
Networking Break in the Virtual Lounge
2:30 pm EST
Spotlight Session: Function Workstreams: Operationally preparing your teams for successful TMF Inspections
3:00 pm EST
Panel
Undergoing Virtual Inspections: Expert Experiences and Guidance (Read More)
- Best practices and shared experiences of remote and hybrid inspections
- Direct access for inspectors
- Communication experiences with regulatory authorities
3:30 pm EST
Summit Concludes