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#268: New Data and Insights on the Vendor Qualification Process in Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-600-L04-P; CME 1.00; RN 1.00

Review and panel discussion of the results from a new Tufts Center for the Study of Drug Development (TCSDD) Working Group study assessing the vendor qualification and selection process

Learning Objectives

Discuss the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Recognize the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Neil McCullough

Panelist
Patty Leuchten

Panelist
Shyard Wong, DrMed

Panelist
Tran V. Huynh


Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
TH

Tran Huynh

Director, Clinical Vendor Strategy, Fortrea, United States
avatar for Patty Leuchten

Patty Leuchten

Founder and CEO, Diligent Pharma, United States
Patricia Leuchten is the Founder and CEO of Diligent Pharma, a quality and compliance organization with tech-enabled service offerings that help mitigate risk in clinical trials. Leuchten has over 30 years of experience as a business owner and entrepreneur in the pharmaceutical industry... Read More →
avatar for Neil McCullough

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, IQVIA, United States
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →
avatar for Shyard Wong

Shyard Wong

Global Head, Clinical Quality and Continuous Improvement, Sanofi, France
A physician by training who graduated from the National University of Singapore in 1991, Shyard Wong rotated through a series of clinical postings in both the public and private healthcare sectors in Singapore and then undertook a career switch to become a full time healthcare administrator... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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