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.

Wednesday| Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Late Stage Research 

Wednesday, February 25

12:35 BRIDGING LUNCHEON CO-PRESENTATION: Engage and Retain Patients in Long-Term Observational Studies

Smurzynski_MarleneMarlene Smurzynski, Ph.D., MSPH, Epidemiologist, Quintiles




Reites_JohnJohn Reites, Senior Director, Offer and Product Development, Health Engagement & Communications, Quintiles







Traditionally, real-world and late phase studies require sites to enroll, engage and retain patients and collect and record patient reported outcomes (PRO), which can be burdensome to both sites and patients. Overtime, sites and patients may lose motivation to participate, contributing to high patient dropout rates, increased study costs and site dissatisfaction. This session will focus on innovative approaches for effectively engaging and retaining patients in long-term studies, such as: identifying design and operational considerations with conducting long-term observational research, understanding site and patient retention challenges, and examining engagement strategies and opportunities for improving retention and compliance.


1:25 Chairperson's Remarks 

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

1:30 Keynote Presentation: Aggregated Review of Clinical Trial Safety Data Plays a Critical Role in Clinical Development Risk Management

Sean ZhaoSean 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 Pharmacovigilance for Social Networks and Digital Media

Nariman A NasserNariman A Nasser, CCRP, Digital Strategist, Patient Recruitment & Retention, Roche

Matt MillerMatt Miller, Associate Director of Marketing, WCCT Global

  • Regulatory considerations for AE monitoring/reporting of digital and social networking channels for patient recruitment & retention
  • Current state of Sponsor perceptions of social media influence on clinical trial participation
  • Patient and site data perspective of social media influence on clinical trial participation
  • Effective use of digital and social networking tools of managing content


3:15 Refreshment Break in the Exhibit Hall

4:05 Chairperson’s Remarks

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

4:10 European Guideline on Good Pharmacovigilance Practices (GVP) - Module XVI - Risk Minimization Measures

AliciaGilsenanAlicia Gilsenan, Ph.D., Senior Director, Epidemiology, RTI Health Solutions



Objectives of the talk are to:

  • Provide overview of EMA's Module XVI
  • Differences between routine versus additional risk minimization measures
  • Examples of additional risk minimization measures
  • Overview of requirements for evaluation of the effectiveness of risk minimization measures
  • Identify factors for consideration in the design, implementation and evaluation of additional risk minimization measures
  • Timing
  • Stakeholders considerations
  • Reporting requirements
  • Ethics, privacy and overall feasibility

Mapi4:35 Adverse Event Management in Non-Interventional Studies

Miranda DollenMiranda Dollen, Vice President, Pharmacovigilance, Mapi Group

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

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Late Stage Research 

Thursday, February 26

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


8:15 Chairperson’s Remarks

Miranda DollenMiranda Dollen, Vice President, Pharmacovigilance, Mapi Group





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

Stephen FurlongStephen 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 HoskinJohn 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 Reviewing Safety Data - Typical Use Patterns with Visual Analytics

 EricHerbelEric Herbel, President, Integrated Clinical Systems, Inc.

A presentation of a wide variety of typical use patterns helpful when reviewing safety data - including AE risk assessment, with subgroup investigation, visually determining outliers and zooming to the details of subject experience (patients or case reports).

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!)

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Late Stage Research 

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