Achieving Data Quality and Integrity in Maximum Containment LaboratoriesFDA-UTMB Collaborative Education Program

2023 course dates to be announced.Please check back later for more information!

Course Description:

The four and one-half day training program is offered annually utilizing expert faculty from the Food and Drug Administration, academia, and business and industry. The course includes laboratory activities conducted in mock Biosafety Level (BSL) 2 and BSL-4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.

Prerequisite Knowledge:

A basic understanding of the FDA Good Laboratory Practice regulations (21 CFR Part 58) is highly recommended. To meet this need, access to two free online courses will be provided to course attendees:

  • GLP Basic Training — This twelve (12) self-paced module on-line course is designed as an introductory course to the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and includes an IACUC Essentials module addressing the oversight responsibilities of the Institutional Animal Care and Use Committee (IACUC).
  • GLP Refresher Training — This self-paced on-line course is designed to refresh knowledge for attendees previously familiar with the GLP regulations.

Credits awarded: This course is submitted for Continuing Education credits for physicians, nurses, veterinarians, and quality assurance professionals. Details will be posted closer to course dates.

Target Audience: Scientists, Principal Investigators, Veterinarians, Pathologists, Sponsors, Quality Assurance Personnel, Physicians, Research Nurses, Regulators, Agency Reviewers, and Policy-makers.

Course Fees: There is no cost to attend, but seating is limited, and pre-registration is required. Note that course attendees are invited based upon diversity of roles, responsibilities, and organization. Interested participants will be placed on a waitlist once seats are filled.

Location: Bethesda Hotel, Bethesda MD

Overall Course Learning Objectives:

  1. Determine requirements needed to conduct high quality studies in high/maximum containment laboratories; therefore, enabling efficient approval of MCMs to improve human health.
  2. Identify criteria used to evaluate MCMs in animal models that reflect human disease.
  3. Resolve complexities of performing studies in high/maximum containment under the Animal Rule, including modern methods to comply with data quality standards.
  4. Leverage One Health initiatives to address public health challenges during a pandemic.

Overall Course Learning Outcomes:

  1. Apply strategies for assessing data quality and integrity in maximum containment laboratories.
  2. Apply principles of good documentation practices for data collection in studies conducted in maximum containment environments.
  3. Apply strategies in clinical practice to communicate One Health initiatives by using an interdisciplinary approach to address public health challenges faced during a pandemic.

Course Curriculum:

  • Animal Rule regulations, and clinical applications of Animal Rule studies
  • Role of the study director
  • BSL-2/3/4 comparison, with hands-on simulations
  • BSL-4 equipment, with hands-on work in a BSL-4 training lab
  • Disease agent characterization
  • GLP regulations
  • Good documentation practices
  • Institutional Animal Care and Use Committee (IACUC) protocols
  • Telemetry
  • Supportive care
  • Surrogate endpoints
  • Testing facility management
  • Veterinary pathology
  • Integration of quality assurance (QA) in BSL-4 studies
  • Advancement of MCMs on the international stage

Course History:

2022

April 25-29, 2022
Bethesda, MD, USA
The Bethesdan Hotel
Hybrid

2021

June 15-18, 2021
Live Virtual

2020

Postponed until the summer of 2021 due to COVID-19 pandemic
Bethesda, MD, USA

2019

April 8 - April 12, 2019
National Institutes of Health (NIH)
Bethesda, MD, USA

2018

April 23- April 27, 2018
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2017

April 24 - April 28, 2017
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2016

April 25 - April 29, 2016
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2015

April 27 - May 1, 2015
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2014

April 28 - May 2, 2014 Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2013

Pilot Course
April 1 - 5, 2013
Galveston National Laboratory
The University of Texas Medical Branch, Galveston, TX, USA