September 28, 2011 - Conference day 2

8:30 Registration & Coffee

8:55 Chairperson’s Recap of Main Conference Day One


9:00 Strategic, Life-Cycle Management of the Product Safety Profile


Information relevant to the safety of a therapeutic product accrues throughout the life cycle. Much can be anticipated even before the first exposures in humans. The nature of the therapeutic agent, proposed indication and characteristics of target population will provide a framework for weighing preclinical data and for planning the clinical program. A proactive approach to defining potential safety issues and a targeted approach to safety endpoints will ensure that safety concerns are appropriately evaluated. Real risks are to be identified and characterized and other potential issues evaluated and removed from the list of active safety concerns.

This session will focus on:

  • Exploring strategic safety issue management
  • Structuring information using a core risk management
  • Using the evolving safety profile to support benefit risk assessments


Dr-Haas Dr. Joanna Haas
Vice President Global Patient Safety and Risk Management
Genzyme Corporation

9:45 The Evolution of REMS: Unintended Consequences on Spontaneous Reporting

In September 2007, Congress enacted the FDA Amendment Act (FDAAA) granting FDA sweeping new authorities, including the ability to require Risk Mitigation and Evaluation Strategies (REMS) of any product with risks that cannot be adequately addressed by labeling alone. At the same time, a shared goal amongst regulators, industry and the public is to assess strategies to increase the speed and predictive value of generating and evaluating safety signals, and to identify next steps to improve the US, Canadian and European systems for identifying and evaluating potential safety signals. There is need to proactively identify and incorporate newer approaches for managing safety information in the early phase of a product in a market. This session will focus on:

  • Impact of spontaneous reporting during REMS program
  • Advantage of strategies to increase the speed and predictive value of generating and evaluating safety signals during a REMS program
  • How each of these approaches can be leveraged to address overall safety and regulatory concerns
  • Unifying the European RMP with the FDA REMS


Maria-Alejandra-Vasquez Maria Alejandra Vazquez-Gragg, MD, MPM, ISOP, GphA
Global Head, Safety and Pharmacovigilance
RTI Health Solutions

10:30 Morning Networking and Refreshment Break

11:15 Help Wanted: Experienced Pharmacovigilance Professionals


The role of a pharmacovigilance professional has changed significantly over the last decade as regulatory scrutiny and requirements have increased. This new role requires an expanded knowledge of public health, epidemiology, risk management principles, and clinical development in order to ensure quality and experienced pharmacovigilance professionals. This session will focus on:

  • The changing professional requirements, competencies and skill sets of pharmacovigilance professionals
  • Challenges to the industry in recruitment, training and retention of PV professionals
  • Future direction of pharmacovigilance – what’s next


Mary-Ellen-Turner Dr. Mary Ellen Turner
Corporate Safety Officer and Vice President

12:00 Networking Luncheon

1:00 Workshop A: Best Practices and Methodology of Post-Approval Non-Interventional Studies

(12:45 Registration for Workshop A)

Non-interventional or observational studies are increasingly included in risk management plans. Pharmaceutical companies are faced with a wide variety of study designs, ranging from prospective, retrospective, and more advanced designs such as selfcontrolled analyses. In parallel, many data sources are available both locally and internationally. Recently, the International Society of Pharmacoepidemiology (ISPE) as well as regulatory authorities such as the FDA and EMA have published guidance on methodological standards in pharmacoepidemiology. How to meet the standards with the available data resources may be challenging.

What will be covered:

  • Differences between the various study designs
  • Availability of the data sources often used in pharmacoepidemiologic research, as well as their advantages and limitations
  • Methodological challenges in conducting pharmacoepidemiologic research
  • How to integrate observational studies in risk management planning

How you will benefit:

  • Understand the differences between the various study designs
  • Be able to select the most appropriate design and data source to address a specific safety concern
  • Understand best practices and needs for methodological standards

Your workshop leader:

Yola Moride
PhD FISPE, Associate Professor
Université de Montréal

3:00 Afternoon Networking and Refreshment Break

3:15 Workshop B: New Direction in Pharmacovigilance & Risk Management

(3:00 Registration for Workshop B)

Novel products are in the pipeline featuring new technologies for pharmaceuticals, drug delivery, diagnostics, devices and over-the counter preparations. Attendees will be participating in case presentations regarding these products and discussions as individuals or in groups. Join us for an interactive workshop with take away exercises and examples that can be utilized within your organization.

What will be covered:

  • The influence of technology on the safety evaluation of a product in the future
  • The extension of pharmacovigilance and risk management beyond the active moiety
  • How safety evaluations may extend beyond the traditional boundaries of pharmacovigilance

How you will benefit:

  • Be prepared for future product safety
  • Know how pharmacovigilance and risk management techniques may have to be expanded now and in the future
  • Learn what you can suggest to improve the safety evaluation of future products for your organization

Your workshop leader:

Mike Bloh
Drug Safety Net LLC

5:15 Chairperson’s Closing Remarks & End of Conference


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Register and pay by August 26, 2011 and receive up to $847 off!

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