20th Annual Conference on Pharmacoepidemiology & Therapeutic

Risk ManagementPresidential Address

Bordeaux, August 23 , 2004

S. Perez-Gutthann, MD, PhD, FISPE, FRCP

Senior Director , Pfizer Global EpidemiologyBarcelona

2003 & 2004 for ISPEites

Strengthening ISPE

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Strengthening ISPE

• Finance & Audit– Judith Jones

• Membership– Annette Stemhagen

• Development Committee– Nancy Dreyer, Americas– Cees Schep, Europe– Kuni Hayashi, Japan

• Nominations & Fellows– Tom MacDonald

• Student Council– Nicole Hartnell & Sean Hennessey

Membership consolidated

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2001 2002 2003 2004

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Strengthening ISPE

• Finance & Audit– Judith Jones

• Membership– Annette Stemhagen

• Development Committee– Nancy Dreyer, Americas– Cees Schep, Europe– Kuni Hayashi, Japan

• Nominations & Fellows– Tom MacDonald

• Student Council– Nicole Hartnell & Sean Hennessey

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Institutional Memory• Bylaws & Policy

– Hugh TilsonTilson

Our Face to the World

Communication

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Communication

• Publications Committee– Chair, Dan Fife– Web, Harry Seifert– ISPE Commentaries, David Lilienfeld – SCRIBE, Rizwan Ahmad

• Public Relations– Yola Moride

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Website

• Webhits up: – up 46% overall, 70% members only

• www.ispe.orgInternationalInternational Society for Pharmaceutical EngineeringSociety for Pharmaceutical Engineering

• www.pharmacoepi.org

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Pharmacoepidemiology & Drug Safety• New: methodological reviews • Large number of accepted papers• Stiff competition for the Best Paper Award

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ImmediacyIndexCitation Score

1.257

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Improving Citations Score

• Continue submitting good papers– State of the art reviews

• Cite recent PDS papers in your publications and letters to the editor

• Cite Good Pharmacoepidemiology Practice Guidelines

Our Face to the World

External Policy

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Policy Responses

• UK Yellow Card Access– Tom Macdonald

• FDA Pharmacogenomics– Bram Hartzema

• IOM Pediatric Medical Device– Corinne de Vries

• FDA Risk Management– Judith Jones– Elizabeth Andrews– Annette Stemhagen

• CERTS 6th PATHS meeting

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Ad Hoc Committee on Good Pharmacoepidemiology Practices

• Chair: Stephan Lanes

• Revision Highlights– Scope

oo InternationalInternationaloo Therapeutic risk managementTherapeutic risk management

– Adverse event reportingoo Study report v. individual casesStudy report v. individual cases

– Protection of human subjectsoo Independent ethics committeesIndependent ethics committees

– Publicationoo ICMJE guidelinesICMJE guidelines

Our Face to the World

Conferences & Education

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2003-2004• Conference Program

– Baltimore April 04, Sue West

– Bordeaux, Nicholas Moore & Annie Fourier

– Barcelona April 05, Elena Rivero

– Nashville August 05, Wayne Ray & Billy Holden

• Education– Jacques LeLorier

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Abstracts & Participants

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Boston Barcelona Toronto Edinburgh Philly Bordeaux

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Support & Oversight

• ISPE Office, Washington– Executive Secretary Mark Epstein

• Board of Directors– 15 members– August 03, April 04, August 04

• Executive Committee

How does the future look?

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Therapeutic safety risk management

• Systematic, planned and integrated approach

• Growing importance of studies and experienced professionals

USA

EU

Japan

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ISPE & Risk Management

• Mission Statement Updated– Open exchange of scientific information among academia,

government and industry, and for development of policy, a provider of education, and an advocate for the fields of pharmacoepidemiology and therapeutic risk management

• Conference focus• Input into Draft Guidances • Initiatives

– Updated Guidance for Good Pharmacoepidemiology Practice– New Guidance on Risk Management Practice

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Further areas to focus

• Cross-national and regional information exchange• Devices• Complementary & herbal medicines• Access and rational prescribing• Product quality

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Sources of Information• Past: database vs. field data collection

• Current: automation supports studies– Database: main source of data– Field: case identification, population sampling

• Distinction likely to become further blurred as computerization of records progresses

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Methodology

• In silico epidemiology: modeling & simulation• Integrating genetic information• New hybrid designs

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Controversies to continue

ISPE ISPE Code of EthicsCode of Ethics

Are we ready for the challenge?

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What are the papers that have shaped the discipline of Pharmacoepi?

• “Pharmacotherapy Revisited” Series”,Esteve Foundation

• Study Population: 37, ISPE convenience sample• 38% response rate• 117 references

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Words of wisdom

...”should not denigrate the observational nature of the data. Most of what we learn, and will continue to learn, about adverse drug effects are from observational studies”

Walker & StampferLancet 1996;348:489

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Keep in mind the origin

• Advancement in safety heavily relies on reporting of safety events by health care professionals

Good Sense of HumorElephant Thick Skin

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THANK YOU