Conference Day Two

8:30 am - 9:00 am Registration and Coffee

9:00 am - 9:10 am Chairmwoman's Recap of Day One

9:10 am - 9:50 am Case Study: A Year-Long Journey in Preparation of an MHRA Inspection

Rebecca Halbur - Senior TMF Manager, Biogen
• Understand the Pros and Cons of a lengthy lead time
• Discuss the unexpected challenges and reflection 
• Review the Takeaways/Lessons Learned from the experience

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Rebecca Halbur

Senior TMF Manager
Biogen

9:50 am - 10:30 am Case Study: Our eTMF Implementation Journey

Pawel Rucki - Senior Manager, TMF Operations, GW Pharma
• Look at our vendor selection considerations
• Review the implementation journey, including post-go live support and training model
• Touch on the key Lessons Learnt, Do’s and Don’ts!

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Pawel Rucki

Senior Manager, TMF Operations
GW Pharma

10:30 am - 11:00 am Networking Coffee Break

11:00 am - 11:40 am Patient Engagement in Clinical Development and TMF

Nancy Meyerson-Hess - Chief Compliance and Regulatory Officer, eMQT
• Look at how regulators like the FDA and EMA are requesting patient involvement in clinical development
• Explore how this relates to E8 and the impact on your TMF documentation process
• Understand how changing the way we involve patients in clinical development means looking into documentation and TMF
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Nancy Meyerson-Hess

Chief Compliance and Regulatory Officer
eMQT

11:40 am - 12:20 pm Case Study: Acquisitions, Collaborations and Divestitures (ACDs) and Their Implications on a TMF

Brenda Brown - Director, TMF Operations Lead, Pfizer

• Discuss meeting legal contractual obligations, planned project timelines, and timing of planned ACD activities

• Look at the confirmation of elements applicable to TMF, as they drive the appropriate process and decisions for integration

• Consider the format of TMF, i.e. paper, electronic or combination; and if, how and when it should be integrated

• Identify important factors for confirming a complete and healthy TMF prior to divestiture 

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Brenda Brown

Director, TMF Operations Lead
Pfizer

12:20 pm - 1:20 pm Networking Lunch

1:20 pm - 2:00 pm How CROs and Sponsors Can Partner to Better Define Effective Sponsor TMF Oversight

Sarah Dean - Director, TMF Operations, Syneos Health
  • Outline how the sponsor can initiate conversations with the CRO to understand existing systems, reports, metrics and TMF expectation to establish an oversight process
  • Discuss how sponsors with an established oversight process can adapt this for a successful relationship
  • Look at how to ensure oversight aligns to the process carried out by the CRO
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Sarah Dean

Director, TMF Operations
Syneos Health

2:00 pm - 2:40 pm Interactive Group Work: What are Your Key Takeaways?

Informal, interactive session where you’ll reflect on your key learnings and bring your specific challenges to the discussion. This session is designed to be a great way to conclude the main conference and provide an opportunity to gain clarity on those final points of ambiguity. In small groups, discuss:


  • What are the key take-home messages from the conference?
  • What are you personally going to prioritise and focus your attention on?
  • Are there any specific strategies that you’re going to implement across your functional teams?

2:40 pm - 3:20 pm Panel Discussion: Where Could Automation and AI Take Us?

3:20 pm - 3:50 pm End of Conference