Cambridge Healthtech Institute’s 3rd Annual

Implementing Risk-Based Monitoring – Part 1:  

Integrating Quality into Clinical Trials
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


Quality and risk management of clinical trials begins with the design and planning of clinical trials at the protocol stage. Cambridge Healthtech Institute’s Third Annual Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials conference provides guidance on how to holistically and proactively build quality standards into clinical trials starting at the protocol stage with emphasis on the latest quality standards and guidelines, including ICH-E6, thereby ensuring higher quality clinical trials and laying the foundation for successful risk-based monitoring.

Preliminary Agenda

Stay on and attend Part 2: Risk-Based Monitoring - Part 2
Keynotes | Monday Short Courses | Speaker Biographies

Monday, January 23

Recommended Pre-Conference Short Course
2:00 - 6:00 pm
SC3: Views and Conversations on Risk-Based Monitoring*
*Separate registration required

Welcome and Networking Happy Hour on the Patio hosted by CHI, DrugDev and Praxis
6:30 - 8:30 pm

Tuesday, January 24 – Wednesday, January 25


OPENING PLENARY KEYNOTES
RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES


Two Keynote Sessions – Tuesday Morning and Wednesday Afternoon

  • Tuesday Morning: RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES
  • Wednesday Afternoon: MOVING TOWARD TRIALS OF THE FUTURE

Featuring:
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology, Genentech, Inc.
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Christine Pierre, President, Society for Clinical Research Sites (SCRS)
John Reites, Head, Digital Health Acceleration, Quintiles
Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.


Grand Opening Coffee Break in the Exhibit Hall


QUALITY STARTING AT THE PROTOCOL LEVEL

Overcoming Challenges During Quality Protocol Development
Sheri Kuss, Associate Director, Clinical Process Development, Teva Pharmaceuticals

Quality by Design: From Theory to Practice
Sabrina Comic-Savic, M.D., MPH, Vice President, GCP Compliance, The Medicines Company; CTTI Quality by Design Team Member

Moving Beyond Risk Assessment: A Comprehensive Risk Management and Protocol Development Process that Builds Quality into Clinical Trials
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Sponsored Presentation by Intralinks


HOW TO APPROACH THE ICH E6 ADDENDUM

Adherence to ICH E6 GCP Guidelines: An Exercise in Mapping Standards, Controls and Metrics
Jonathan Rowe, Ph.D., Executive Director & Head, Quality Performance and Risk Management, Pfizer

CO-PRESENTATION: Sponsor and Vendor Partnering to Implement a ICH E6 Compliant Risk Management Model
Brian Nugent, Associate Director, Clinical Operations & Process, Gilead Sciences
Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences

Sponsored Breakfast Presentation by DrugDev


ASSESSING CLINICAL QUALITY MANAGEMENT SYSTEMS

Assessing the Clinical Quality Management System: Part 1
Janis Little, Vice President, Global R&D Quality, Allergan

Assessing the Clinical Quality Management System: Part 2
Michael Husovich, Director, Global R&D Quality, Amgen


EMBEDDING QBD, RISK ASSESSMENT AND RISK MANAGEMENT FOR RBM

A Risk Based Monitoring (RBM) Implementation: A Roadmap and Lessons Learned
Justin Stark, Director/Head, Risk Based Monitoring, UCB Biosciences, Inc.

‘Stop Light Syndrome’: Why We are the Biggest Risk of All
Gareth Adams, Founder, Syniad Consulting

Bridging Luncheon Sponsored by Omnicomm


INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

View Detailed Interactive Breakout Discussion Groups

Welcome Reception in the Exhibit Hall


Stay on and attend Part 2: Risk-Based Monitoring - Part 2
Keynotes | Monday Short Courses | Speaker Biographies

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Lee Yuan
Conference Director
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com




Signature Sponsor

Bio Clinica Logo

Premier Sponsors

BBK  

ClinicalInk

Comprehend

OmniComm

PRA Health Sciences

QUINTILES

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> 2016 Attendee List

> 2016 Attendee Profile