Investigational New Drug (IND) Applications: What You Need to Know for Successful Interactions with the FDA
An educational program of the NIH Clinical Center-FDA CDER Joint Task Force emphasizing regulatory requirements for clinical trials of new and repurposed drugs, with a special focus on rare diseases.
Target Audience:
Clinical investigators, clinical research study coordinators, clinical and translational research scientists and trainees.
Objectives:
• To provide training in FDA regulations for NIH investigators involved in phase I and phase II clinical trials of investigational drugs, emphasizing safety considerations in the early phases of drug development.
• To describe the IND-enabling elements of non-clin...
Source: Videocast - All Events - November 7, 2013 Category: Journals (General) Tags: Upcoming Events Source Type: video
CC Grand Rounds for Clinical Fellows: The Role of Serendipity in Drug Discovery
Presented by: Hazel H. Szeto, MD, PhD, Professor of Pharmacology; Director, Research Program in Mitrochondrial Therapeutics, Weill Cornell Medical CollegeCategory: Clinical Center Grand RoundsAired date: 08/14/2013 (Source: Videocast - All Events)
Source: Videocast - All Events - August 15, 2013 Category: Journals (General) Tags: Past Events Source Type: video
NLM Informatics Lecture Series: Can Social Media Provide Reliable Signals of Adverse Drug Reactions?
Presented by: Dr. Graciela Gonzalez, PhD, Arizona State UniversityCategory: SpecialAired date: 06/05/2013 (Source: Videocast - All Events)
Source: Videocast - All Events - June 10, 2013 Category: Journals (General) Tags: Past Events Source Type: video
Combinatoriality, Signal Integration and Allostery: Determinants of Specific Transcriptional Regulation by the Glucocorticoid Receptor
Presented by: Keith R. Yamamoto, Ph.D., Executive Vice Dean, University of California at San Francisco School of Medicine; Vice Chancellor for Research, and Professor, Cellular and Molecular Pharmacology, University of California at San FranciscoCategory: Wednesday Afternoon LecturesAired date: 06/05/2013 (Source: Videocast - All Events)
Source: Videocast - All Events - June 7, 2013 Category: Journals (General) Tags: Past Events Source Type: video
NLM Informatics Lecture Series: Can Social Media Provide Reliable Signals of Adverse Drug Reactions? (NIH Only)
Pre-market testing of drugs produces reasonably high quality information about the efficacy of the drug as a treatment for the condition for which it was approved, but gives a very incomplete picture of the drug’s safety. It is only after a drug is marketed and used on a more widespread basis over longer periods of time that it is possible to identify other effects, such as rare but serious adverse effects, or those that are more common in the special subgroups excluded from the trial, among others. Post-marketing surveillance currently relies on voluntary reporting to the FDA by health care professionals (and recently, ...
Source: Videocast - All Events - May 9, 2013 Category: Journals (General) Tags: Upcoming Events Source Type: video
Careers in Govenment
Video Podcast (CC)Presented by: Stephanie Courchesne, Ph.D., Health Science Policy Analyst, NIH; Hillary Carter, Ph.D., Program Officer for Biosecurity Engagement Program, US Department of State; Wolf Lindwasser, Ph.D., Program Director for the Coordinating Center for Clinical Trials, NIH; Immo Zadezensky, Ph.D., Clinical Pharmacology Lead at the Center for Drug Evaluation and Research, Food and Drug Administration; Chuck Selden, Ph.D., Extramural Staff Training Officer, NIH Aired date: 3/11/2013 3:00:00 PM Eastern Time (Source: Videocast Podcasts)
Source: Videocast Podcasts - March 11, 2013 Category: Journals (General) Authors: National Institutes of Health Tags: Health Source Type: video
Careers in Govenment
Audio PodcastPresented by: Stephanie Courchesne, Ph.D., Health Science Policy Analyst, NIH; Hillary Carter, Ph.D., Program Officer for Biosecurity Engagement Program, US Department of State; Wolf Lindwasser, Ph.D., Program Director for the Coordinating Center for Clinical Trials, NIH; Immo Zadezensky, Ph.D., Clinical Pharmacology Lead at the Center for Drug Evaluation and Research, Food and Drug Administration; Chuck Selden, Ph.D., Extramural Staff Training Officer, NIH Aired date: 3/11/2013 3:00:00 PM Eastern Time (Source: Videocast Podcasts)
Source: Videocast Podcasts - March 11, 2013 Category: Journals (General) Authors: National Institutes of Health Tags: Health Source Type: video
Research advances and clinical and public health implications of genetic therapy
RESEARCH ADVANCES AND CLINICAL AND PUBLIC HEALTH IMPLICATIONS OF GENETIC THERAPYPresented by: Helen Blau, PH.D. Donald E. and Delia B. Baxter Professor and Chair, Department of Molecular Pharmacology, Director, Gene Therapy Technology, Stanford
Category: WALS - Wednesday Afternoon LecturesAired date: 03/22/2000 (Source: Videocast - All Events)
Source: Videocast - All Events - March 22, 2000 Category: Journals (General) Tags: Past Events Source Type: video
