EL-PFDD Introductory Webinar

This webinar provides an overview of EL-PFDD meetings, including more about the format, purpose, and goal of this meeting. It will also provide additional details about participating in the January 2023 meeting. Learn more and register for the Jan. 24 EL-PFDD at creatineinfo.org/el-pfdd
Timestamps:
00:00 EL-PFDD Introductory Webinar
02:28 What is the purpose of the meeting
03:06 Why should we all participate?
05:37 Introduction of Speakers: James E. Valentine, JD, NHS, and Larry J. Bauer, MA, RN
07:15 Background on FDA and Drug Development and General Steps (James E. Valentine)
09:45 Drug Discovery
11:41 Development Stages (Preclinical-Phase I-Phase II-Phase II-NDA Filing-Safety Surveillance)
28:15 FDA's Role
32:35 Introduction to Patient-Focused Drug Development (Larry J. Bauer)
33:40 Benefit-Risk Assessment
36:11 The basis of the FDA's decision making
37:34 "Voice of the Patient" Report
38:54 Meeting Logistics for January 24, 2023
40:10 Overview of the Agenda
41:14 Discussion Questions: Topic 1 (Living with CCDS: Disease Symptoms and Daily Impacts) and Topic 2 (Current Challenges to Treating CCDS)
42:56 Discussion format for January 24, 2023
43:56 Tips for Effective Participation and How to Register
45:37 Summary of the EL-PFDD Introductory Webinar
46:30 Question and Answers