Archives: Agenda
Tactics and eTools for Inspection Readiness in Diagnostics: Lessons learned from US and ROW inspections, and how the preparation differs depending on the auditing body
- Lessons learned in the Diagnostics space
- Use of eSystems data / information in Inspection Readiness
- Understanding the expectations of your Auditor (FDA vs. EU Notified Body)
The value of strategic early engagement to maximize sponsor/CRO partnerships
- How early engagement can improve outcomes
- How do we speak the same language, no one size fits all approach
- Simplifying the complex in a world of overwhelming options and models
Panel Discussion Unravelling the impact of ICH E6(R3) on Good Clinical Practice
- How to implement
- Different approaches
- Interpretations
- Meaningful differences from ICH E6 R2
Chair’s Opening Remarks
Risky Business: Take Some Chances on Vendor Management
- Who needs to be risky? – vendor management team
- What tools are needed to manage risks?
- What qualification activities are needed? Less audits?
- How much oversight and management?
Speaker Hosted Roundtables
Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.
RT1 – Collaboration on trial design and execution to ensure study success
Stacey Curelop, Director of Clinical Operations, Mycovia Pharmaceuticals
RT2 – Beyond Compliance: Fostering a culture of inclusion in Clinical Trials
Bianca Green, Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda
RT3 – Strategies for Smaller Pharma & Biotech’s to Overcome Financial and Resource Challenges
Ros Cheetham, Vice President Clinical Operations, MacroGenics
Diversity and inclusion in clinical trials
- How strategic partnerships can positively impact diversity in clinical trials
- Leveraging these partnerships to enhance community engagement
- Planning for diversity at the onset
PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success
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- Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up.
- How to optimize collaboration with patient advocacy organizations
- Discussing recipes for success and the challenges which are still visible.
- Real-life examples: when has it worked, when hasn’t it and why?
The Broken Business Development/Sponsor Relationship and How to Fix it from Both Perspectives
- Best and worst business development practices for reaching sponsors
- Best and worst practices for sponsors working with BD in seeking quotes and outsourced work
- Understanding and respecting each party’s requirements and pressures