Cambridge Healthtech Institute’s Inaugural 

QbD and Risk Assessment for Clinical Trial Conduct  

Laying the Foundation for Risk-Based Monitoring
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL 


Dear Colleague:

I am pleased to announce production of CHI’s Inaugural “QbD and Risk Assessment for Clinical Trial Conduct: Laying the Foundation for Risk-Based Monitoring” being held February 24-25, 2015 at the Hyatt Regency in Orlando, FL.

The gathering will be part of the 6th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 700 leaders in clinical operations and research in February 2014. Please see the overall program map below for 2015.

Topics to be discussed at the “QbD and Risk Assessment for Clinical Trial Conduct: Laying the Foundation for Risk-Based Monitoring” conference include: 

  • Identification, prevention, mitigation and management of risk in clinical trial studies
  • Building QbD and risk management into clinical conduct, including protocol development and study set-up
  • Establishing an Integrated Quality Risk Management Plan (IQRMP)
  • Creating a clinical operations quality & risk framework  
  • Identification of critical data and processes for RBM 
  • Establishing a framework for deploying RBM across the enterprise
  • Regulatory expectations for RBM – alignment of monitoring practices with regulations
  • Leveraging IT, tools and techniques for risk assessment in RBM
  • Establishing appropriate metrics, key risk indicators/triggers and alerts
  • Understanding quality risk indicators (QRI) – what is being measured, how is it measured, what data sources are used, and do they reflect actual escalated risk

If you are interested in presenting, please click here to submit a speaking proposal for review.

Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academic /hospital centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

Deadline for submission is July 11, 2014. 

2015 Summit for Clinical Ops Executives (SCOPE) Conference at a Glance Large 

SCOPE 2014 Wrap-Up
Held February 4-6, 2014, in Miami, Florida, the 5th Annual SCOPE Summit gathered more than 700 industry leaders, an attendance increase of 18% from 2013, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 11 different conference tracks, a Clinical Informatics News Best Practices Awards and two plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Recruitment and Retention, Social Media and Mobile Tech, Project Management, Forecasting, Aggregate Spend Compliance, Post-Marketing Studies, and Sample Logistics. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (16%), CRO (32%), and Biotech companies (26%). Industry leaders and key decision makers representing 16 different countries and more than 350 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com 
 
For partnering and sponsorship information, please contact:
Ilana Quigley
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 

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) (www.chicorporate.com) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Events, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group.


 

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