Rebecca Halbur

Senior TMF Manager Biogen

Conference Day One

Tuesday, September 15th, 2020

3:00 PM Break Out Discussions

It is no secret that the best strategies are formed through expert collaboration! During this activity, break off into small groups and collaborate with your peers. Choose one topic below and after 30 minutes; rotate around to another topic area for discussion.

1.Preparation for an MHRA Inspection
             Rebecca Halbur, Senior Manager Trial Master File, Biogen

2.Transitioning to an eTMF
               Sarah Neglo, Clinical Research Associate, Chiesi

3.Patient Engagement in Clinical Development  
               Nancy Meyerson-Hess, Chief Compliance and Regulatory Officer, eMQT

4.TMF Audit Plan 
               Mary MacDonald, Director, GCP Quality Assurance, Radius Health

4:00 PM PANEL DISCUSSION: What is the Best Practice for Staying ‘On-Track’?

• What measures can you take to avoid a back log with your filing?
• Do you perform spot-checks and how many times do you have missing documentation?
• Determine strategies you can put in place to ensure your TMF system is complete

Conference Day Two

Wednesday, September 16th, 2020

9:10 AM Case Study: A Year-Long Journey in Preparation of an MHRA Inspection

• Understand the Pros and Cons of a lengthy lead time
• Discuss the unexpected challenges and reflection 
• Review the Takeaways/Lessons Learned from the experience

Check out the incredible speaker line-up to see who will be joining Rebecca.

Download The Latest Agenda