Program Highlight: Seminar Weekend

Seminar weekend is a requirement of the program for students pursuing the M.S. option. It’s housed every spring at the main University of Florida campus in Gainesville. It’s an opportunity for students to focus on a relevant topic, work in teams to produce a project, and personally meet each other and program faculty. Time and again, it’s named one of the most rewarding aspects of the program by current students and alumni.

The 2020 Seminar Weekend took place on March 7 – 8 and focused on real world evidence.

Seminar Highlights

Track Director

“Seminar is really a highlight our online Master’s program in Pharmaceutical Outcomes and Policy.”

– Laura Happe, Pharm.D., M.P.H, Manger Care Pharmacy Track Director

Student Testimonial

“I think this was an amazing aspect to finally see people that you always heard their voices, or saw their names during the courses, and also to have the experience to be on campus.”

– Khaled Abdelgawwad, Berlin Germany

Track Director

“It’s an opportunity to exchange ideas, and from the student’s perspective to also network.”

– Vakaramoko Diaby, Ph.D., M.Sc, Applied Pharmacoeconomics Track Director

Topic Overview

Real-world evidence: Can it be used in the real world?

The 21st Century Cures Act required the Food and Drug Administration to establish a program to evaluate real-world evidence, or RWE, for new drug indications and to support post-approval requirements. Several professional organizations have responded by publishing joint statements and white papers promoting enhanced transparency, reproducibility and usability of RWE studies, including the International Society for Pharmacoeconomics and Outcomes Research, the International Society for Pharmacoepidemiology, the National Pharmaceutical Council and AcademyHealth.

This seminar will explore how RWE is currently being used and address these questions:

  • What are the barriers?
  • What is the current status of the use of RWE by the FDA?
  • How can RWE be used to protect patient safety?
  • How can researchers improve their reporting to increase trust?
  • Should registration of observational studies be required?

Agenda

Saturday, March 7, 2020

HPNP Auditorium (unless otherwise noted)

TimeSession TitleSpeaker
12 -1 PMRegistration (HPNP central entrance)
1-1:15 PMWelcome and IntroductionsLaura Happe, Pharm.D., M.P.H.,
Associate Professor and Track Director
University of Florida College of Pharmacy
1:15-2 PMFramework for FDA's RWE PorgramKenneth Quinto, M.D., M.P.H.,
Senior Medical Advisor for RWE
U.S. Food and Drug Administration
2-2:45 PMRWE and the pharmaceutical industryDavid Van Brunt, Ph.D., M.S.,
Head, Evidence and Analytics, Health Economics and Outcomes Research
AbbVie
2:45-3 PMBreak
3-3:45 PMUse of RWE studies in formulary decisionsPrabashni Reddy, MMedSc, R.Ph., Director, Center for Drug Policy
Partners Healthcare
3:45-4:30 PMProtecting patient safety using RWEDarren Toh, ScD,
Chief Scientist, FDA Sentinel Operations Center
Harvard Medical School
4:30-4:45 PMBreak
4:45-6 PMWhat does the future hold for RWE?Panel Discussion
6-7 PMBreak (Students attending the program for academic credit will be completing group assignments during this time.)
7-9 PMStudent/Speaker/Faculty Dinner Discussion (HPNP foyer)

Sunday, March 8, 2020

HPNP Auditorium (unless otherwise noted)

TimeSession TitleSpeaker
7-8 AMContinental breakfast (HPNP foyer)
8-8:45 AMOvercoming barriers to use of RWEJennifer Graff,
Vice President
National Pharmaceutical Council
8:45-9:30 AMRegistration of RWE studiesLucinda Orsini, D.P.M., M.P.H.,
Associate Chief Science Officer
ISPOR
9:30-9:45 AMBreak
9:45-10:30 AMTransparency and replicability of RWE studiesShirley Wang, Ph.D.,
Assistant Professor of Pharmacoepidemiology
Harvard University
10:30-11:15 PMData science and pharmacoepidemiologic methods in RWE: what can we learn from each other and where must we differ?Almut Winterstein, Ph.D.,
Professor and Chair
University of Florida College of Pharmacy
President
ISPE
11:15-12 PMHow can we improve RWE? Panel Discussion
12 PMProgram adjourned for all except students/faculty of POP program, and those attending seminar for academic credit.

Student Testimonials

Check out our student testimonials!

Hear why students chose POP to further enhance their career goals and learn about a few program highlights

Shana Durham POP Testimonial