Cambridge Healthtech Institute’s Inaugural  

Pharmacovigilance and Adverse Events Reporting  

Optimizing Safety Monitoring and Safety Reporting Practices
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL 

Drug adverse events detection and analysis is one of the main goals of any clinical trial, and post-marketing safety surveillance is one of the main functions of late stage research and post-marketing studies and registries. Pharmacovigilance science or drug safety relies heavily on strategic approaches and operational advances that can be applied to any therapeutic areas. Cambridge Healthtech Institute is adding the “Pharmacovigilance and Adverse Events Reporting” conference to the SCOPE mix of topics for the first time in order to fulfill the need of coverage and information exchange for this important part of clinical research. Some of the specific topics to be discussed are AE aggregate analysis, technology and social media in pharmacovigilance research, risk minimization, and others.

Adverse Events Detection and Analysis 

Aggregated Review of Clinical Trial Safety Data Plays a Critical Role in Clinical Development Risk Management

Sean Zhao, M.D., Head, US Safety Surveillance, AstraZeneca  

Signal Detection and Evaluation for Drug Induced Liver Injury during Clinical Phases of Drug Development 

Arie Regev, M.D., Head, Safety Advisory Hub, Chairman, Liver and GI Safety Committee, Global Patient Safety, Eli Lilly & Company 

Drug Safety Risk Minimization  

Sundos Hamza, M.D., Senior Vice President, Drug Safety Risk Management, InterMune 

Technology to Enable Pharmacovigilance Research 

Implementing New Safety Monitoring Tools: Opportunities and Challenges  

Stephen Furlong, Ph.D., Safety Science Lead, Safety Science Section, Patient Safety, AstraZeneca  

New Challenges Facing PV and Information Technology Strategies to Meet Them 

John Hoskin, Director, AEGIS Operations, Pharmacovigilance and Patient Safety, Abbvie 

Adverse Event Reporting for Social Listening, Melissa Mottolo 

Melissa Thompson, Patient Recruitment Strategy Associate, Genentech 

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:
Marina Filshtinsky, M.D.
Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496

For partnering and sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

About Cambridge Healthtech Institute (CHI)
Founded in 1992, Cambridge Healthtech Institute (CHI) ( 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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