Skip navigation
Agenda

Benchmark with International Peers to Gauge RBM Performance, Efficiencies, Implementation and Technologies

September 13-14, 2018
  • London, United Kingdom

Agenda

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, 13 SEPTEMBER 2018

7:30

Conference Registration

8:30

Co-Chairs’ Welcome and Opening Remarks

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

8:45

LUMINARY ADDRESS Bring RBM from Pilot to Complete Implementation

Monika Mörsch
Team Lead, Risk Based Quality Management, Risk Based Monitoring
Boehringer-Ingelheim

Optimise your Trial Team and
Partners for RBM Effeciency

9:30

Create and Capture Efficiencies for Central Monitors

Anna Herradon
Associate Director, Site Monitoring Manager, Bristol-Myers Squibb;
Country Lead, TransCelerate Spain

10:15

Networking and Refreshment Break

10:45

Evaluate the RBM Capabilities and Competencies of a CRO

Amy Loescher
Head, Outsourcing Partner Management, Risk Management Central Monitoring
Janssen

Plan, Implement and Enhance RBM Protocols

11:30

Develop an Internal Readiness Assessment for RBM to Determine When it’s Time to Implement

Nurcan Coskun
Global Risk Based Monitoring Program & Technology Solutions Manager
Medtronic

12:15

Networking Luncheon

13:15

ROUNDTABLE Benchmark ICH E6 R2 Implementation and Interpretation

Moderator:

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

14:15

U.K., U.S., Scandinavia, Australia, China, and Thailand — Regional Considerations and Implementation

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

15:00

Implement RBM at Scale —
Key Considerations for Low Volume Trials from the Medical Device Industry

Thomas Naeschen
Clinical Project Manager
Boston Scientific

15:45

Networking and Refreshment Break

16:15

Apply an Exploratory Methodology to RBM to Identify Hidden Risks

Julie Solbjerg Appel
Clinical Data Surveillance Specialist
Novo Nordisk

17:00

Implement Quality Limits and Adhere to Emerging Regulatory Guidelines in RBM

Lukasz Bojarski, PhD
Associate Director, Centralised Monitoring
AstraZeneca

15:45

Chairperson’s Closing Remarks

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

6:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO FRIDAY, 14 SEPTEMBER 2018

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

8:15

Develop RACTs and Risk Classifications to Support Creation of a Standardised Risks and Tools Library

Gavin Boodoo
Risk Based Monitoring Consultant
Roche

9:15

INTERACTIVE SESSION Mock Inspection Design and Streamlining RBM to Be Audit Ready

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

10:15

Networking and Refreshment Break

RBM Technical Mastery — Enhance Algorithms, Evaluate Technologies and Optimise System Validation

10:45

CASE STUDY Strategies to Implement Technologies into RBM Programs and Processes

Carolina Errobidart
Central Monitor
Bristol-Myers Squibb

11:30

System Validation Best Practices and Protocols

Marcel Merfort, PhD
Business Application Manager, Clinical Operations, System & Process Excellence
Roche

12:15

Networking Luncheon

13:15

Networking and Refreshment Break

13:45

Develop Risk Indicators for Clinical Endpoints

Morten Thorup Pedersen
Risk Based Monitoring Specialist
Novo Nordisk

14:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, 13 SEPTEMBER 2018

7:30

Conference Registration

8:30

Co-Chairs’ Welcome and Opening Remarks

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

8:45

LUMINARY ADDRESS Bring RBM from Pilot to Complete Implementation

Monika Mörsch
Team Lead, Risk Based Quality Management, Risk Based Monitoring
Boehringer-Ingelheim

Optimise your Trial Team and
Partners for RBM Effeciency

9:30

Create and Capture Efficiencies for Central Monitors

Anna Herradon
Associate Director, Site Monitoring Manager, Bristol-Myers Squibb;
Country Lead, TransCelerate Spain

10:15

Networking and Refreshment Break

10:45

Evaluate the RBM Capabilities and Competencies of a CRO

Amy Loescher
Head, Outsourcing Partner Management, Risk Management Central Monitoring
Janssen

Plan, Implement and Enhance RBM Protocols

11:30

Develop an Internal Readiness Assessment for RBM to Determine When it’s Time to Implement

Nurcan Coskun
Global Risk Based Monitoring Program & Technology Solutions Manager
Medtronic

12:15

Networking Luncheon

13:15

ROUNDTABLE Benchmark ICH E6 R2 Implementation and Interpretation

Moderator:

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

14:15

U.K., U.S., Scandinavia, Australia, China, and Thailand — Regional Considerations and Implementation

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

15:00

Implement RBM at Scale —
Key Considerations for Low Volume Trials from the Medical Device Industry

Thomas Naeschen
Clinical Project Manager
Boston Scientific

15:45

Networking and Refreshment Break

16:15

Apply an Exploratory Methodology to RBM to Identify Hidden Risks

Julie Solbjerg Appel
Clinical Data Surveillance Specialist
Novo Nordisk

17:00

Implement Quality Limits and Adhere to Emerging Regulatory Guidelines in RBM

Lukasz Bojarski, PhD
Associate Director, Centralised Monitoring
AstraZeneca

15:45

Chairperson’s Closing Remarks

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

6:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO FRIDAY, 14 SEPTEMBER 2018

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

Carol Knott
Head of Monitoring and Nurse Training
University of Oxford

8:15

Develop RACTs and Risk Classifications to Support Creation of a Standardised Risks and Tools Library

Gavin Boodoo
Risk Based Monitoring Consultant
Roche

9:15

INTERACTIVE SESSION Mock Inspection Design and Streamlining RBM to Be Audit Ready

Lisa Berdan
Director, Global Megatrials
Duke Clinical Research Institute

10:15

Networking and Refreshment Break

RBM Technical Mastery — Enhance Algorithms, Evaluate Technologies and Optimise System Validation

10:45

CASE STUDY Strategies to Implement Technologies into RBM Programs and Processes

Carolina Errobidart
Central Monitor
Bristol-Myers Squibb

11:30

System Validation Best Practices and Protocols

Marcel Merfort, PhD
Business Application Manager, Clinical Operations, System & Process Excellence
Roche

12:15

Networking Luncheon

13:15

Networking and Refreshment Break

13:45

Develop Risk Indicators for Clinical Endpoints

Morten Thorup Pedersen
Risk Based Monitoring Specialist
Novo Nordisk

14:30

Close of Conference