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Development, Regulatory, and Outcomes (DRO) Network

Network Goals
  • Enhance communication, cross-training and collaborations among members from multiple sectors including industry, government, and academia 
  • Apply principles of clinical pharmacology in the continuum of drug development, regulation, and post-marketing research and surveillance, as well as safe and effective utilization of medicines.
Network News

Network Webinar
Upcoming Webinar
Title: FDA’s Sentinel System and the Regulatory Process
Date and Time: November 28, 2017, 1:00 PM EST
Speaker: Michael Nguyen, MD, US Food and Drug Administration
Moderator: Joshua Gagne, PharmD, ScD, Brigham and Women's Hospital and Harvard Medical School
Description: The Sentinel System allows FDA to proactively assess products’ safety and, as a result, the FDA is better able to understand the risks of medical products. A key aspect of Sentinel’s integration is the requirement that FDA first consider the sufficiency of Sentinel’s Active Risk Identification and Analysis (ARIA) system prior to issuing a postmarket required study (PMR). This presentation will review the background on Sentinel, introduce ARIA, and provide an illustrative example of how FDA is implementing these capabilities within the legislative framework set forth by FDAAA.
Learning Objectives: After attending the webinar participants will be able to:
  • Recognize the background and need for proactive medical product safety assessment
  • Identify the capabilities of Sentinel’s Risk Identification and Analysis System and how it supports regulatory decision-making
Registration Link: https://attendee.gotowebinar.com/register/8457146959157303298

Past Webinars
PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction

When are Transporters Important in Drug Disposition Including Tissue Distribution of Drugs?
Go here to view this webinar. (Members only)

Network Leadership

Network Chair
Lei Zhang, PhD
US Food and Drug Administration

Dr. Zhang is Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology, Office of Translational Sciences, the Center for Drug Evaluation and Research, the U.S. Food and Drug Administration (OCP/OTS/CDER/FDA). She is an accomplished professional with more than 17 years of combined experiences in the areas of drug research, development and regulatory review and approval. 
Read her full bio here.
   

Network Chair
Donald L. Heald, PhD
Janssen R&D
Biologics Clinical Pharmacology

Read his full bio here.

Communities
Drug Utilization & Outcomes
Early Development & Drug Safety
Global Health
Regulatory Science

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