News & Press: General News

Training Course on Clinical Investigation and Medical Products [FDA Notice]

Friday, September 23, 2016   (0 Comments)
Posted by: Whitney Lingafelter
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The Food and Drug Administration (FDA), in collaboration with 
the University of Maryland Center of Excellence in Regulatory Science 
and Innovation (M-CERSI), is announcing a 3-day training course for 
clinical investigators on the scientific, ethical, and regulatory 
aspects of clinical trials for medical products. This training course 
is intended to provide clinical investigators, such as clinicians, 
nurses, pharmacists, and other health care providers involved in 
conducting clinical trials, with expertise in the design, conduct, and 
analysis of clinical trials; to improve the quality of clinical trials; 
and to enhance the safety of trial participants. Senior FDA staff, 
along with other experts, will present on issues critical for 
successful conduct of clinical research.

DATES: The training course will be held on November 7, 2016, from 8:20 
a.m. to 5:30 p.m. (registration begins at 7:30 a.m.); on November 8, 
2016, from 8:30 a.m. to 4:45 p.m.; and on November 9, 2016, from 8:30 
a.m. to 3:30 p.m.

ADDRESSES: The course will be held at the Silver Spring Civic Building 
at Veterans Plaza, One Veterans Place, Silver Spring, MD 20910. GPS 
device address: 8525 Fenton St., Silver Spring, MD 20910. For 
additional information, please refer to (FDA has verified the Web address, but FDA is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.)

FOR FURTHER INFORMATION CONTACT: Nicole Silva, Office of Medical 
Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6323, Silver 
Spring, MD 20993, 301-796-3419,


I. Background

    Clinical trial investigators play a critical role in the 
development of medical products. They bear the responsibility for 
ensuring the safe and ethical treatment of study subjects and for 
acquiring adequate and reliable data to support regulatory decisions. 
This course is intended to train clinical investigators in all elements 
of clinical trials, including the preclinical and clinical information 
needed to support the investigational use of medical products; the 
statistical design of trials; and scientific, regulatory, and ethical 
considerations related to conduct of clinical trials. The course 
lecturers will include a diverse representation of senior FDA staff and 
other experts, enabling communication on issues critical for successful 
conduct of clinical research.

II. Description of the Training Course

A. Purpose

    The training course is designed to provide clinical investigators 
with an overview of the following information:
     The essential toxicological, pharmacological, and 
manufacturing data to support investigational use in humans;
     Fundamental issues in the design and conduct of clinical 
     Statistical and analytic considerations in the 
interpretation of trial data;
     Appropriate safety evaluation during studies; and
     The ethical considerations and regulatory requirements for 
clinical trials.
    In addition, the course aims to:
     Foster a cadre of clinical investigators with knowledge, 
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and 
     Enhance investigators' understanding of FDA's role in 
experimental medicine;
     Improve the quality of clinical trial data; and
     Enhance protection of subjects in clinical trials.

B. Agenda

    The course will be conducted over 3 days and will be presented 
mainly by senior FDA staff with other lecturers presenting on selected 
topics. The agenda is available at

C. Target Audience

    The course is targeted toward clinicians, nurses, pharmacists and 
other health care professionals responsible for, or involved in, the 
conduct and/or design of clinical trials.
    Registration: There is no registration fee to attend this in-person 

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course; however, seats are limited and registration will be on a first-
come, first-served basis. To register, you need to complete the 
registration online by October 28, 2016, at Upon 
completion of registration, you will receive an email that confirms 
your registration. There will be no onsite registration or remote 
access for this training.
    Accommodations: Attendees are responsible for their own hotel 
accommodations. If you need special accommodations due to a disability, 
please contact Nicole Silva (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days in advance. Persons attending the course are advised that 
FDA is not responsible for providing access to electrical outlets.