24 - 27 September, 2018 | Postillion Convention Centre, Amsterdam, Netherlands

Conference Day Two

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

9:00 am - 9:10 am Chairman's Welcome to Day Two

Eldin Rammell - Managing Director Rammell Consulting
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Eldin Rammell

Managing Director
Rammell Consulting

9:10 am - 9:55 am The Big Picture of Inspection Management

Scott McCulloch - Director, GCP Quality, and TMF RM SC Member InClin Inc
- Lessons learned from regulatory inspections and making necessary improvements
- Taking a risk-based approach to Inspection preparation.
- Determine the best structure when preparing for regulatory inspections
- Benefits of hosting a Mock Inspection and address areas of risk
- Understand how TMF fits into the preparing holistically for inspection
- Evaluate best practices in inspection readiness
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Scott McCulloch

Director, GCP Quality, and TMF RM SC Member
InClin Inc

9:55 am - 10:35 am The Effect of GDPR on eTMF Management

Ian Slack - Director, Clinical Data Management Vertex Pharmaceuticals
-Understand how to interpret GDPR in relation to eTMF
-Gage best practice in ensuring GDPR Compliance
-Examine considerations needed to adjust you approach to the requirements
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Ian Slack

Director, Clinical Data Management
Vertex Pharmaceuticals

10:35 am - 11:05 am Morning Coffee Break

11:05 am - 12:15 pm Seminar: What is Best Practice in TMF Management?

Francisca Diala - Clinical Research specialist (Clinical Documentation) Expert Consultant
This seminar will open with a short presentation follow by a group discussion identifying the key areas of focus for TMF completion. We will:
- Open conversation with overlapping approaches to best practice in TMF management
- Deliberate what 'best practice' means and how to achieve it
- Understand the difference of opinion in TMF priorities and determine what customisable approach you need to take to be inspection ready
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Francisca Diala

Clinical Research specialist (Clinical Documentation)
Expert Consultant

12:15 pm - 1:15 pm Networking Lunch

1:15 pm - 1:55 pm Managing the Multiple Functions of an eTMF

Rebecca Halbur - Sr TMF Manager Biogen
- Discuss how challenges will continue to grow as new technologies develop
-Understand how to improve management of different TMF functions
-Focus on different approached to TMF management beyond data repositories
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Rebecca Halbur

Sr TMF Manager
Biogen

1:55 pm - 2:40 pm Scenario Roundtables

Each round table will discuss a different “what if” scenario that mirrors a real TMF Inspection situation. Develop strategies to overcome these likely scenarios and share past experiences and ideas. You won’t know the scenario until you choose your round table so get ready for some on-the-spot problem solving and out of the box thinking with your industry peers!

2:40 pm - 3:10 pm Afternoon Coffee Break

3:10 pm - 3:50 pm TMF Practice of the Future

Emmie McFarlane - Head of Records Management Clintec
-Discuss how future digital trends is going to influence the way we view TMF
-Determine how to bring more efficient methods of working with eTMF platforms
-Gain clarity in how solutions need to keep up to date with regulatory demands
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Emmie McFarlane

Head of Records Management
Clintec

3:50 pm - 4:10 pm Summative Panel: What are the Next Steps for TMF?

-Determine the key take aways in managing TMF for inspection
-Understand the different roles and responsibility in inspection readiness
-Evaluate the role of eTMF and integrate a new proactive method of working

4:10 pm - 4:20 pm Chairman's Closing Remarks

Eldin Rammell - Managing Director Rammell Consulting
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Eldin Rammell

Managing Director
Rammell Consulting