A major milestone in risk management took place in early May. The US Food and Drug Administration (FDA) released the three long awaited draft guidance documents on risk management.

For a long time, pharmacoepidemiology studies — and by that I refer to epidemiology studies on therapeutics — have been the main focus of our activities as a Society, as these studies are key in evaluating the safety of therapeutic agents as used in final target populations. However, therapeutic risk management initiatives across the world have started to change the way the benefit risk of therapeutic agents is evaluated and improved. This change includes the systematic and planned estimation and evaluation of risk, determination of acceptable level of risk, communication of risk, implementation of interventions to minimize risk, and the evaluation of the effectiveness of these activities. Taken separately these activities are not new. What is a change — and it is an important one — is the systematic, planned and integrated approach to these activities. And as the application of safety risk management approach evolves, pharmacoepidemiology studies will increase in number and in relative importance in therapeutic research portfolios. As professionals working in this area, we will, and in fact are, expected to provide both the population based evidence through pharmacoepidemiological studies and data, as well as the public health perspective to propose, plan and evaluate these activities.

In anticipation of this shift and consistent with the strategic planning process initiated two year ago, ISPE added risk management to its strategic objectives and mission and integrated therapeutic risk management into the scope of its annual conference. A year later, after the FDA public hearings in which ISPE, among others, presented its perspective on three FDA risk management concept papers, we have another opportunity to provide our views on FDA guidelines, which are likely to shape the practice of therapeutic safety risk management and epidemiology.

ISPE’s review and comment process on three FDA draft risk management guidance is underway. Elizabeth Andrews, Annette Stemhagen and Judith Jones have volunteered to coordinate the Society’s responses to these guidelines. Initial member comments and suggestions were provided on the drafts. The ISPE draft positions will be posted in the Members Only section for review and comment. Final comments will be sent to the FDA by the July 6 deadline.

• Development and Use of Risk Minimization Action Plans
  Coordinator: Elizabeth Andrews, at eandrews@rti.org

• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
  Coordinator: Annette Stemhagen, at Annette.Stemhagen@covance.com

• Premarketing Risk Assessment
  Coordinator: Judith Jones, at jkjones@deggegroup.com

• General comments
  Coordinator: Susana Perez-Gutthann, at susana.perez@pfizer.com

ISPE members also are invited to offer their comments on the updated and revised ISPE Guidelines for Good Pharmacoepidemiology Practices. Under Steve Lanes lead, a working group has broadened the scope of the guidelines both geographically, to reflect our international membership, and conceptually, to include risk management and pharmacoeconomic activities, and to address more clearly the role of epidemiologic studies from industry and regulatory perspectives, including adverse event reporting requirements as they relate both to individual cases and to aggregate data. Please read the committee update in this issue of Scribe.

Thanks to Sue West for organizing the very successful symposium Changing behaviors: How do we do it? How do we know when we've done it? This is Sue’s second highly successful Mid-Year Symposium. More than 150 people attended this year’s Mid-Year Symposium. You might remember Sue coordinated the planning for the 2000 Mid-Year Symposium in Chapel Hill, which was attended by more than 200 people. Thanks also to Judith Jones and Jacques Le Lorier for organizing the Introduction to Pharmacoepidemiology. And again to Sue West and her UNC-Chapel Hill colleagues for delivering an outstanding Advanced Topics in Pharmacoepidemiology session. All of the Mid-Year educational programs were well attended and very well received, thereby encouraging ISPE to move forward with this extended format at future Mid-Year meetings. I encourage you to read the report of the Mid-Year Meeting in Baltimore in this issue of Scribe, and to visit the Members Only section of the ISPE website where the presentations are posted.

Close to the Baltimore's beisbol and football stadiums, one of the largest Scientific Program Committee meetings (85 committee members) ever, chaired by Nicholas Moore, placed the finishing touches of 20^th Annual International Conference on Pharmacoepidemiology & Therapeutic Risk Management. The meeting will be held in Bordeaux, 20-25 August 2004. The committee’s challenge was to accommodate the record number of abstract submitted for podium and oral presentations, as well as the also increasingly growing number of proposals submitted for workshops and symposia. Bernard Begaud, long time ISPE member and President of Victor Segalen University in Bordeaux will be our keynote speaker. Other invited speakers include Lucien Abenhaim, also an ISPE founding member, who will talk of his four years as Director General of Health in France, Nicholas Wald of Polypill fame, and Sami Suissa from McGill University, Montreal. Information about the meeting is posted on the website, www.pharmacoepi.org as it becomes available.

Member involvement is critical to the Society’s long-term success. The increasing number of participants in a variety of ISPE activities suggests we are doing something right.

Thank you for your participation. I look forward to seeing you in Bordeaux for what promises to be the biggest and best annual meeting!

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