Shaping the Future of Pharmacoepidemiology

Sunday, August 28, 2022

10:30 AM – 12:00 PM CEST

Location: C1M5

Publication Number: 242

Background: The breadth and scope of pharmacoepidemiology has been broadened, exemplified by increasing roles of real-world evidence in clinical and regulatory decision-making, new and evolving data sources, or emerging involvement of data sciences that may not follow causal inference frameworks. A new concise definition for pharmacoepidemiology has also been proposed by ISPE founding members to include biologics and devices. (1) Accordingly challenges exist in identifying and developing the core competencies and curricula that are needed by not only academia, but also government or industry. For this reason, they are a high priority for review and reconsideration. An ISPE working group project is in progress to assess core competencies and the current state of pharmacoepidemiology training in programs around the globe. Previously identified core competencies will be reviewed and modernized to inform contemporary curricula recommendations for pharmacoepidemiology training and programs.

Objectives: (1) To present, review, discuss and refine the proposed updates to core competencies in pharmacoepidemiology (including the definition of pharmacoepidemiology)
(2) To identify training needs in pharmacoepidemiology
(3) To obtain feedback on a proposed survey of pharmacoepidemiology program content and structure
(4) To develop pharmacoepidemiology core curriculum recommendations most relevant for current ISPE member needs
All ISPE members in academia, government and industry who are interested in discussing and shaping pharmacoepidemiology and the future of this specialist training would benefit from attending.

Description: The workshop will be divided into four sections to cover each of the objectives. A short presentation will be given to the entire workshop group on the core competencies, including a presentation on the updated definition of pharmacoepidemiology, followed by panel discussions (objective 1). Subsequently, roundtable discussions in smaller groups led by a working group member will be held (objectives 2 and 4). At the end of each discussion session, each group will be asked to provide up to 2 key points. All topics discussed in each group will also be recorded by working group members. The final session will consist of a presentation on the proposed survey of pharmacoepidemiology program content and structure, followed by a panel led discussion (objective 3). The feedback obtained will be used as an indicator of ISPE membership opinion on the revised definition and to refine recommendations for updated core competencies and curricula in pharmacoepidemiology.
(1) Edlavitch SA and Tilson HH. Commentary: For consideration by pharmacoepidemiologists. PDS 2021;30:1619-1620

Presenting Author(s)

Vicki Osborne, PhD

Jazz Pharmaceuticals
Cambridge, Cambridgeshire, United Kingdom

Slides

Author(s)

Deborah Layton, PhD, FISPE

Principal
PEPI Consultancy Limited
Southampton, England, United Kingdom
AG

Amie Goodin, PhD, MPP

University of Florida
Gainesville, Florida, United States

Slides
Almut Winterstein, PhD, FISPE

Distinguished Professor
University of Florida
Gainesville, Florida, United States
Andrew Bate

GSK, United Kingdom
Catherine Cohet, PhD

Pharmacoepidemiology/RWE Senior Specialist
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands
XK

Xavier Kurz, MD

Head of Data Analytics
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands
Lisa G. Pont, PhD, FISPE

Professor
University of Technology Sydney
Chippendale, New South Wales, Australia
DM

David Moeny, MPH

US Food and Drug Administration
Silver Spring, Maryland, United States
Olaf H. Klungel, PharmD, PhD

Professor
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Utrecht, Netherlands
Simone P. Pinheiro, MSc, ScD

Senior Director/Head
AbbVie
North Chicago, Illinois, United States
John D. Seeger, PharmD, FISPE

Optum Epidemiology
Boston, Massachusetts, United States
KC

K. Arnold Chan, MD, ScD, FISPE

Professor
National Taiwan University
Taipei, Taipei, Taiwan (Republic of China)
SE

Stanley Edlavitch, PhD, MA

Professor
University of Missouri–Kansas City
Kansas City, Missouri, United States
HT

Hugh Tilson

FISPE, United States
JB

Joshua Brown, PharmD, PhD

Assistant Professor
Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL USA
Gainesville, FL, United States