21 - 22 October, 2020
| Online
Webinar Day 1
1:30 pm - 2:15 pm
Preparing for a physical MHRA inspection and a digital Health Canada Audit – Comparisons and Contrasts
Rebecca Halbur -
Associate Director, TMF Systems,
Biogen
· Understand the Pros and Cons of a lengthy lead time vs a couple of months
· Discuss the unexpected challenges and reflection from both the MHRA and Health Canada audit experiences
· Review the Takeaways/Lessons Learned from both experiences and how you can maintain your process oversight remotely
2:15 pm - 2:50 pm
Closed-Loop Audit Inspection Readiness
Robert Weisz -
Director - EU Quality Strategy,
Veeva Systems
Pinar Bérénice Bénet - Senior Director Strategy, Clinical Operations, Veeva Systems
· How the cloud enables remote inspections
· Leveraging a unified platform to access all GCP documents and provide evidence of oversight
· Best practices for efficient collaboration with partners on audit finding responses
2:50 pm - 3:25 pm
A Day of Reckoning: Pre-Inspection Activities
Mia Grasty -
TMF Analyst,
LMK Clinical Research Consulting
Set yourself up for success by
· Being Inspection Conscious
· Knowing Your Key Stakeholders
· Keeping Your Eyes on the Prize
3:25 pm - 3:45 pm
Short Coffee Break
3:45 pm - 4:30 pm
Achieving Inspection Readiness through leveraging technology and streamlining oversight
Laura Naranjo -
Associate Director, TMF Operations,
Daiichi Sankyo
- Discuss the reasons and requirements behind DSIs decision to streamline their TMF QC and CRO oversight activities
- Map out how this was implemented within DSI and where the biggest process challenges lay
- Examine the benefits to inspection readiness and CRO management through this process with reference also to the remote inspection environment
4:30 pm - 5:15 pm
Panel Discussion: Collaboration and Communication under Covid-19: How has ‘Audit Preparedness’ Changed?
Brenda Brown -
Director, TMF Operations Lead,
Pfizer
Rebecca Halbur - Associate Director, TMF Systems, Biogen
Jamie Marie Toth - Senior Director - Clinical Systems & Records , Global Clinical Operations & Planning, Daiichi Sankyo
