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.

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Wednesday, February 25


Speaker to be Announced


1:25 Chairperson’s Remarks

Paul Landesman, Ph.D., Contract Consultant, Drug Safety Risk Management, InterMune, Inc.

1:30 Regulatory Environment and Innovative Pharmacovigilance

Michael Ibara, Head, Business Development Coordination & Innovation, Drug Safety, Pfizer
The underlying problem is that we are using the rules and regulations and concept which were developed when data was hard to find. This presentation will discuss how internet and social media changed this paradigm.

1:55 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

FDA’s guidance of “Safety Reporting Requirements for INDs and BA/BE Studies” suggests sponsor conduct ongoing periodic aggregate analysis and review of specific safety events occurred in clinical trials that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group. The presentation will focus on (1) establishing risk thresholds of event of special interests in the clinical development program; (2) building standard tools, systems, and process for aggregated safety analysis and review; (3) escalating and managing identified potential risks; and (4) reporting and communicating safety findings from aggregated analysis to FDA and all participating investigators.

2:20 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

Despite increasing efforts to understand and predict idiosyncratic drug induced liver injury (IDILI) it remains largely unpredictable. Currently, the best time to try and identify a drug’s potential to cause IDILI, may be during early clinical development. During this phase, the differentiation between hepatic events which can predict IDILI and those that are not predictive of IDILI is of critical importance. This presentation will review current approaches to identification and monitoring of suspected IDILI during clinical phases of drug development.

2:45 Sponsored Presentation (Opportunity Available)

3:15 Refreshment Break in the Exhibit Hall

4:05 Chairperson’s Remarks

4:10 Drug Safety Risk Minimization

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

The goal of risk minimization is to minimize a product’s risks while preserving its benefits. Benefit and risk information emerges continually throughout a product’s lifecycle (i.e., during the investigational and marketing phases) and can reflect the results of both labeled and off-label uses. This presentation will discuss strategies and technologies to minimize drug safety risk.

4:35 Adverse Event Management in Non-Interventional Studies

Miranda Dollen, Vice President, Pharmacovigilance, Optum

Adverse event management for non-interventional post-authorisation safety studies conducted in the European Economic Area must comply with the requirements of Module VI of Good Pharmacovigilance Practices. This session reviews the impact of the September 2014 update to Module VI, looking at practical considerations for study design and protocol development.

4:50 Supplemental Data Collection to Confirm Medical Events (ME) in Post-Marketing Pharmacoepidemiology Database Studies

Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc.

Existing electronic databases represent useful platforms to conduct pharmacoepidemiology studies. The data generating mechanism can influence the reliability of identified medical events and the validity of analysis. The ability to confirm potential ME may be necessary to draw appropriate inferences from the study. It may be conducted in a targeted manner to address study-specific concerns and may involve validation of algorithms in all or a sample of the study population. This presentation will provide an in-depth discussion on the necessity, approaches and operation of medical event confirmation.

5:15 PANEL DISCUSSION: Streamlining Drug Safety Efforts from Clinical Trials to Post Marketing Surveillance

Moderator: Paul Landesman, Ph.D., Contract Consultant, Drug Safety Risk Management, InterMune, Inc.

In continued efforts to focus on bringing effective drugs to market without causing harm to patients, the pharmaceutical industry has invested heavily into improving safety profiles of drugs and therapies. New technologies and analytical methods have been employed to evaluate risks of drugs and potential adverse events, which has led to more systematic approaches to identifying and analyzing pre and post-market risks.

Topics to be discussed:

  • Getting the basic of Clinical Study Safety Reporting, including aggregate reports
  • Congratulations, your drug has been approved but not in all of your target Markets: Safety reporting for both clinical and post-market settings
  • Study roll-over decisions and documentation: Transitioning patients into Early Access or Post-marketing programs
  • Post-market Reporting: Solicited and Spontaneous requirements in an environment of Patient Support Programs

5:40 Reception in the Exhibit Hall

7:00 Close of Day

Day 1 | Day 2 | Download Brochure 

Thursday, February 26

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


8:15 Chairperson’s Remarks

8:20 Implementing New Safety Monitoring Tools: Opportunities and Challenges

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

In recent years rapid progress has been made in developing new tools for monitoring patient safety. These tools range from new biochemical biomarkers and imaging techniques for monitoring drug induced organ toxicity, to genetic approaches that can help with risk assessment, to new informatics and statistical tools for collecting and analyzing safety data. In this presentation we will review some of these new tools, and discuss approaches and challenges for moving these tools from exploratory studies to using them for effective monitoring of patients.

8:45 New Challenges Facing PV and Information Technology Strategies to Meet Them

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

Pharmacovigilance has moved from the wings to center stage in recent years. Higher scrutiny of product safety and greater focus on benefit/risk have brought more attention to safety and have had major impacts on PV organizations. Even more changes are in the offing and they are coming at a faster pace than ever before. New regulations, higher case volumes, additional sources of data, and availability of new analytical tools and processes - all will require new approaches to address. This session will explore some of these challenges and suggest technical strategies the industry might adopt

9:10 Adverse Event Reporting for Social Listening

Melissa Thompson, Patient Recruitment Strategy Associate, Genentech

Social listening can be a powerful tool but there are reservation in collecting insights from patients and caregivers due to the possibility of discovering adverse events. In this session we will explore the use of social listening to aid in patient recruitment and retention, with a focus on prevalence of reportable AEs on social media platforms and the methodology/timing of reporting findings.

9:35 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall

10:40 Closing Plenary Keynote

1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)

Day 1 | Day 2 | Download Brochure 

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