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DAY ONE THURSDAY, 14 SEPTEMBER 2017

8:00

Welcome and Refreshments

9:00

Co-Chairs’ Welcome and Opening Remarks

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

9:15

KEYNOTE ADDRESS Design Global Organisation Wide Risk Based Monitoring Protocols

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

Gain Clarity on Global Regulatory Expectations for Risk-Based Quality Focused Monitoring in Clinical Trials

10:00

ROUNDTABLE Prepare for the ICH E6 (R2) Addendum —
How Will it Affect Risk-Based Monitoring

MODERATOR:

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

10:45

Networking and Refreshment Break

11:15

Beyond the Impact — Innovative Strategies for Adoption and Implementation of ICH E6

Ana Herradón
Senior Site Monitor Manager & CDQMs
Bristol-Myers Squibb

12:00

CASE STUDY Implement RBM and Measure Results from Inception to Everyday Usage

Steven Thys
Managing Director
Servier R&D

12:45

Networking Luncheon

14:00

Optimize Site Performance Through a Holistic, Quality-Based Approach to Monitoring

Malcolm Weaver
Senior Director
Medidata Solutions

Andy Lawton
Consultant
Risk Based Approach Ltd

14:45

Centralized Risk-Based Monitoring for Large Scale Global Trials

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

15:30

Networking and Refreshment Break

16:00

Beyond RBM — How Intelligent Analytics are Being Used to Drive Regulatory Inspections and Support ICH Compliance

Francois Torche
Chief Executive Officer
CluePoints

16:45

Analytical Risk Based Monitoring Studies — A Janssen Japan Perspective

Tomokazu Handa
Trial Operation Department / Central Monitoring Group,
Japan Clinical Operations, R&D Division
Janssen Pharmaceuticals

17:30

Close of Day One

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

DAY TWO FRIDAY, 15 SEPTEMBER 2017

8:30

Welcome and Refreshments

9:00

Co-Chairs’ Review of Day One

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

9:15

Centralised Site Monitoring on RBM Studies to Improve Efficiency and Overcome Bottlenecks

Carolina Errobidart
Central Monitor
Bristol-Myers Squibb

10:00

Using Technology to Minimize Risk and Issues and Comply with ICH GCP Guidelines

Julian Ortiz
Senior Specialist, Central Monitoring
Janssen Pharmaceuticals

10:45

Design a Dynamic Programme-Wide RBM Pilot to Ensure Robust Capabilities and Oversight

Adam Baumgart
Senior Director, Xcellerate Monitoring Solutions Development
Covance

11:30

Networking and Refreshment Break

12:00

Identify Easily Missed Site Performance Gaps

Mette Krogh Beyer
Clinical Data Surveillance Specialist
Novo Nordisk

12:45

Networking Luncheon

14:00

Quality vs Efficiency Risk-Based Monitoring Models

Jakub Tyszecki
Centralized Monitoring Therapy Area Lead
AstraZeneca

14:45

Defining and Tracking Global Monitoring Excellence

Mary Arnould
Associate Director, Monitoring Excellence
Bristol-Myers Squibb

15:30

Close of Conference

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DAY ONE THURSDAY, 14 SEPTEMBER 2017

8:00

Welcome and Refreshments

9:00

Co-Chairs’ Welcome and Opening Remarks

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

9:15

KEYNOTE ADDRESS Design Global Organisation Wide Risk Based Monitoring Protocols

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

Gain Clarity on Global Regulatory Expectations for Risk-Based Quality Focused Monitoring in Clinical Trials

10:00

ROUNDTABLE Prepare for the ICH E6 (R2) Addendum —
How Will it Affect Risk-Based Monitoring

MODERATOR:

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

10:45

Networking and Refreshment Break

11:15

Beyond the Impact — Innovative Strategies for Adoption and Implementation of ICH E6

Ana Herradón
Senior Site Monitor Manager & CDQMs
Bristol-Myers Squibb

12:00

CASE STUDY Implement RBM and Measure Results from Inception to Everyday Usage

Steven Thys
Managing Director
Servier R&D

12:45

Networking Luncheon

14:00

Optimize Site Performance Through a Holistic, Quality-Based Approach to Monitoring

Malcolm Weaver
Senior Director
Medidata Solutions

Andy Lawton
Consultant
Risk Based Approach Ltd

14:45

Centralized Risk-Based Monitoring for Large Scale Global Trials

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

15:30

Networking and Refreshment Break

16:00

Beyond RBM — How Intelligent Analytics are Being Used to Drive Regulatory Inspections and Support ICH Compliance

Francois Torche
Chief Executive Officer
CluePoints

16:45

Analytical Risk Based Monitoring Studies — A Janssen Japan Perspective

Tomokazu Handa
Trial Operation Department / Central Monitoring Group,
Japan Clinical Operations, R&D Division
Janssen Pharmaceuticals

17:30

Close of Day One

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

DAY TWO FRIDAY, 15 SEPTEMBER 2017

8:30

Welcome and Refreshments

9:00

Co-Chairs’ Review of Day One

Lisa Berdan
Director, Global Mega Trials
Duke Clinical Research Institute

Stephanie Clark
Associate Director, Risk Management, Central Monitoring
Janssen Pharmaceuticals

9:15

Centralised Site Monitoring on RBM Studies to Improve Efficiency and Overcome Bottlenecks

Carolina Errobidart
Central Monitor
Bristol-Myers Squibb

10:00

Using Technology to Minimize Risk and Issues and Comply with ICH GCP Guidelines

Julian Ortiz
Senior Specialist, Central Monitoring
Janssen Pharmaceuticals

10:45

Design a Dynamic Programme-Wide RBM Pilot to Ensure Robust Capabilities and Oversight

Adam Baumgart
Senior Director, Xcellerate Monitoring Solutions Development
Covance

11:30

Networking and Refreshment Break

12:00

Identify Easily Missed Site Performance Gaps

Mette Krogh Beyer
Clinical Data Surveillance Specialist
Novo Nordisk

12:45

Networking Luncheon

14:00

Quality vs Efficiency Risk-Based Monitoring Models

Jakub Tyszecki
Centralized Monitoring Therapy Area Lead
AstraZeneca

14:45

Defining and Tracking Global Monitoring Excellence

Mary Arnould
Associate Director, Monitoring Excellence
Bristol-Myers Squibb

15:30

Close of Conference