Cambridge Healthtech Institute’s 6th Annual

Implementing Risk-Based Monitoring – Part 1

Integrating Quality into Clinical Trials

February 19-20, 2020


Poor quality and risk management of clinical trials significantly impacts the success, timeliness, and cost-effectiveness of clinical trials. CHI’s 6th Annual Implementing Risk-Based Monitoring – Part 1 conference provides lessons learned, case studies, and ample discussion on building and maintaining proper clinical quality management systems with emphasis on the latest quality standards and guidelines, including recent changes to ensure higher-quality clinical trials and laying the foundation for successful risk-based monitoring. The program will focus on successful RBM implementation tactics employed by large, small, and mid-sized organizations. A special session is designed to discuss RBM in medical device trials.

Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring – Part 2

Scientific Advisory Board

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

 

Preliminary Agenda

LINKING QUALITY AND RBM

CO-PRESENTATION: The Application of Quality Tolerance Limits (QTLs) as Described in ICH E6 R2

Ruma Bhagat, MPH, MBBS, Senior GCP Strategy Lead, Site Innovation Group Lead, Genentech, Inc.
Jonathan Rowe, PhD, Executive Director & Head, Quality Performance and Risk Management, Pfizer Inc.

CO-PRESENTATION: Bridging the Gap Between Issue Management and Risk-Based Quality Management

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.

Centralized RBM: DOs and DON’Ts

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

RISK-BASED MONITORING FOR MEDICAL DEVICE TRIALS

Addressing Risk-Based Monitoring of Device Trials and the Impact of ICH E6 R2

Michelle Wetherby, Associate Director, Global Clinical Operations, Abbott

CO-PRESENTATION: Risk-Based Monitoring at Johnson & Johnson: From Pharma to Medical Device Clinical Trials

Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products

Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

Re-Skilling for AI/ML: Leveraging Your SMEs

Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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 key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and 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: www.scopesummit.com/breakouts

 

Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring – Part 2




For more details on the conference, please contact:

Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781.972.5496

Email: mfilshtinsky@healthtech.com


For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com


Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com