Cambridge Healthtech Institute’s 5th Annual

Implementing Risk-Based Monitoring – Part 1

Integrating Quality into Clinical Trials

February 19-20, 2019


Poor quality and risk management of clinical trials significantly impacts the success, timeliness and cost-effectiveness of clinical trials. Cambridge Healthtech Institute’s 5th Annual “Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials” 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 the recent ICH-E6 R2 addendum changes, thereby ensuring higher quality clinical trials and laying the foundation for successful risk-based monitoring. The program will also focus on successful RBM implementation tactics employed by small and mid-sized organizations.


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


Monday, February 18

PRE-CON USER GROUPS, KICK-OFF KEYNOTE, PARTICIPANT ENGAGEMENT AWARDS, & SCOPE’S KICK-OFF NETWORKING HAPPY HOUR

Monday Afternoon User Group Meetings & Hosted Workshops (opportunities available): www.scopesummit.com/pre_conference_user_group_meetings

Plenary Keynotes: www.scopesummit.com/keynotes

Participant Engagement Award: www.scopesummit.com/participant-engagement-award


Tuesday, February 19 – Wednesday, February 20 (Part 1 of SCOPE)

REALIZING RISKS WITH YOUR CLINICAL QUALITY MANAGEMENT SYSTEMS

CO-PRESENTATION: How to Build a Clinical Quality Management System from the Ground Up

Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Angie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

A Risk Management Case Study: Evolution of Pfizer’s Integrated Quality Risk Management Plan and Realization of Risks

Sheri Kuss, Director, Clinical Quality Management, Pfizer

NEW APPROACHES TO CLINICAL TRIAL QUALITY

The Use of Predictive Models, Quality Tolerance Limits and Anomaly Detection to Drive and Oversee RBM

Jonathan Rowe, PhD, Executive Director & Head, Quality Performance and Risk Management, Pfizer

SMALL & MID-SIZE PHARMA CASE STUDIES ON IMPLEMENTING RBM

Case Study: How Alkermes Created a Risk-Based Data Quality Oversight Framework

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

RBM & SAMPLE MANAGEMENT

Specimen-Centric Considerations for Possible Extensions of Risk-Based Monitoring (RBM) Principles

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

The Risk Assessment as a Foundation for RBM – Engaging Functional Area Stakeholders

Suzanne Lukac, Director, Risk-Based Monitoring Implementation, Merck

Bridging Luncheon Presentation (Sponsorship Opportunity Available)

PLENARY KEYNOTES

 
Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:
 
SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.
 
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

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
 
Tuesday PM Welcome Reception in the Exhibit Hall
 

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


For more details on the conference, please contact:
Lee Yuan

Conference Director

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5404
Email: lyuan@cambridgeinnovationinstitute.com

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com

Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.1349
Email: prose@healthtech.com

Signature Sponsor

IQVIA


Premier Sponsors

Appian

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT

PRA Health Sciences

Praxis

Syneos Health

UBC

Veeva