20th Annual Conference on Pharmacoepidemiology ...
Post on 28-Jan-2022
4 Views
Preview:
Transcript
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
4
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
6
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
9
Communication
• Publications Committee– Chair, Dan Fife– Web, Harry Seifert– ISPE Commentaries, David Lilienfeld – SCRIBE, Rizwan Ahmad
• Public Relations– Yola Moride
10
Website
• Webhits up: – up 46% overall, 70% members only
• www.ispe.orgInternationalInternational Society for Pharmaceutical EngineeringSociety for Pharmaceutical Engineering
• www.pharmacoepi.org
11
Pharmacoepidemiology & Drug Safety• New: methodological reviews • Large number of accepted papers• Stiff competition for the Best Paper Award
0,000
0,200
0,400
0,600
0,800
1,000
1,200
1,400
1999 2001* 2003
ImmediacyIndexCitation Score
1.257
12
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
14
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
15
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
24
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
25
Abstracts & Participants
0100200300400500600700800900
Boston Barcelona Toronto Edinburgh Philly Bordeaux
26
Support & Oversight
• ISPE Office, Washington– Executive Secretary Mark Epstein
• Board of Directors– 15 members– August 03, April 04, August 04
• Executive Committee
28
Therapeutic safety risk management
• Systematic, planned and integrated approach
• Growing importance of studies and experienced professionals
USA
EU
Japan
29
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
30
Further areas to focus
• Cross-national and regional information exchange• Devices• Complementary & herbal medicines• Access and rational prescribing• Product quality
31
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
32
Methodology
• In silico epidemiology: modeling & simulation• Integrating genetic information• New hybrid designs
35
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
45
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
46
Keep in mind the origin
• Advancement in safety heavily relies on reporting of safety events by health care professionals
top related