Skip Main Navigation
Eventbrite
Browse Events
Organize an event
Organize
Help
Log InSign Up
Menu
Page Content
This event has ended.

Dec

18

Patient-Focused Drug Development: Collecting Comprehensive & Representative...

by United States Food and Drug Administration

Actions and Detail Panel

Sales Ended

Date and time

Mon, December 18, 2017

9:00 AM – 5:00 PM EST

Location

FDA White Oak Campus

10903 New Hampshire Ave.

Building 31, Room 1503 (Great Room)

Silver Spring, MD 20993

View map

Description

On December 18th, FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. The workshop will focus on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI).

The purpose of this public workshop is to obtain feedback from stakeholders on consideration for:


(1) Standardized nomenclature and terminologies for patient-focused drug development

(2) Methods to collect meaningful patient input throughout the drug development process

(3) Methodological consideration for data collection, reporting, management, and analysis of patient input


FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers and other interested persons. Approximately one month before the workshop, FDA will publish a discussion document that outlines potential approaches and methodological considerations for data collection, reporting, management, and analysis of patient input. FDA will be specifically interested in obtaining your comments on the approaches and considerations proposed in the discussion document during the workshop.


Please visit the FDA website for the workshop for additional information and meeting materials.

Tags

  • United States Events
  • Maryland Events
  • Things to do in White Oak, MD
  • White Oak Classes
  • White Oak Science & Tech Classes
Event ended

Patient-Focused Drug Development: Collecting Comprehensive & Representative Input


Follow this organizer to stay informed on future events

United States Food and Drug Administration

Event creator

Events you might like

  • IE Brown Coffee Chat with an IE Representative - DC

    IE Brown Coffee Chat with an IE Representative - DC
    IE Brown Coffee Chat with an IE Representative - DC

    Fri, Sep 23, 1:00 PM
    TBC Washington DC • Washington DC, DC
    Free
  • Coffee Chat with an IE Representative - Washington DC

    Coffee Chat with an IE Representative - Washington DC
    Coffee Chat with an IE Representative - Washington DC

    Tue, Aug 30, 9:00 AM
    Studio at 900 19th St • Washington DC, DC
    Free
  • Medical Cannabis New Patient Registration Event

    Medical Cannabis New Patient Registration Event
    Medical Cannabis New Patient Registration Event

    Sat, Aug 27, 12:00 PM
    11722 Reisterstown Rd • Reisterstown, MD
    Free
  • Medical Cannabis New Patient Registration Event

    Medical Cannabis New Patient Registration Event
    Medical Cannabis New Patient Registration Event

    Sat, Aug 20, 12:00 PM
    10011 Stedwick Rd • Gaithersburg, MD
    Free
  • Medical Cannabis New Patient Registration Event

    Medical Cannabis New Patient Registration Event
    Medical Cannabis New Patient Registration Event

    Sat, Aug 20, 12:00 PM
    Curaleaf MD Columbia • Columbia, MD
    Free
  • Medical Cannabis New Patient Registration Event

    Medical Cannabis New Patient Registration Event
    Medical Cannabis New Patient Registration Event

    Sat, Aug 20, 12:00 PM
    106 N Frederick Ave • Gaithersburg, MD
    Free
  • neXco National Live! Cocktails & Commerce (Real Estate Focused)

    neXco National Live! Cocktails & Commerce (Real Estate Focused)
    neXco National Live! Cocktails & Commerce (Real Estate Focused)

    Wed, Sep 21, 4:30 PM
    The HON Company • Washington, DC
    Free
  • MDIC Annual Patient Forum

    MDIC Annual Patient Forum
    MDIC Annual Patient Forum

    Mon, Sep 12, 9:00 AM
    JW Marriott Washington, DC • Washington, DC
    $50 - $350
  • HOW TO RECRUIT & RETAIN PATIENTS FOR YOUR CLINIC?

    HOW TO RECRUIT & RETAIN PATIENTS FOR YOUR CLINIC?
    HOW TO RECRUIT & RETAIN PATIENTS FOR YOUR CLINIC?

    Thu, Aug 18, 7:00 PM
    ONLINE • WASHINGTON D.C, DC
    Free
  • Summer Supper at BKK Cookshop (vegan/produce focused)

    Summer Supper at BKK Cookshop (vegan/produce focused)
    Summer Supper at BKK Cookshop (vegan/produce focused)

    Mon, Aug 29, 6:00 PM
    BKK Cookshop • Washington, DC
    $60

Site Navigation

Use Eventbrite

  • How it Works
  • Pricing
  • Event Blog

Plan events

  • Online Registration
  • Sell Event Tickets
  • Event Management Software

Find events

  • Browse Silver Spring Events
  • Get the Eventbrite App

Connect with us

  • Report This Event
  • Help Center
  • Terms
  • Privacy
  • CA Privacy Notice
  • Accessibility
  • Community Guidelines
Eventbrite + Ticketfly

© 2022 Eventbrite