UAMS.EDU

Webinars

FDANews

“ClinicalTrials.gov and the New Final Rule (42 CFR Part 11)”
Date: Wednesday, August 2, 2017
Time: 12:30 PM – 2:00 PM
Location: COPH/RAHN Building Room G226

Overview

FDAnews is addressing the confusion with a new webinar featuring a leading light of the FDA regulatory bar, Scott Cunningham Esq., translating the knottiest provisions of the final regulation into simple English. Here’s what you’ll discover:

  • The four elements of an “applicable drug clinical trial,” and how the FDA will interpret what these words really mean
  • Who must submit clinical trial results to ClinicalTrials.gov
  • Clinical trial data submissions deadlines
  • The enforcement landscape: What the FDA can do to police non-compliance, and when enforcement might start
  • Deciphering the ClinicalTrials.gov “voluntary submissions” provisions
  • Navigating provisions on “delayed submission” of results to ClinicalTrials.gov
  • FDA proposals for release of de-identified data — current status
  • And much more!

1.5 CRS credit hours

Click here to register via My Compass


AALAS

“Animal Protocols: Strategy for an Effective IACUC Review”
Date: Thursday, August 10, 2017
Time: 12:00 PM – 1:30 PM
Location: Biomed I B205/207 (IACUC Meeting Room)

Overview

IACUC deliberation is key to humane, safe, and well-reasoned use of animals in research and teaching. When reviewing a protocol, the IACUC balances costs and benefits to arrive at a decision on approval. Costs include animal lives, pain or distress, and resources. Benefits include knowledge to advance science and medicine. In this webinar, we will walk through the protocol review process with the strategy of posing questions to understand how animals will be studied from start to finish, including details that directly affect animal welfare. These questions bring out what is required in a protocol with a focus on aspects that bear on humane and regulatory considerations, and prepare IACUC members to effectively discuss the protocol.

Learning objectives:

  • Identify that issues that must be addressed in an animal protocol.
  • Apply a strategy for an effective review of an animal protocol.
  • Assess the potential for animal pain and/or distress based on the descriptions of the procedures in a protocol.
  • Audience: IACUC members and veterinarians

1.5 CRS credit hours

Click here to register via My Compass


HCCA

“Investigator Initiated Trials – Administrative Considerations for Successful Study Start-up and Close”
Date: Thursday, August 31, 2017
Time: 12:00 PM – 1:30 PM
Location: COPH/RAHN Building Room G228

Main points covered:
  • How to articulate study status (interventional vs observational) during protocol development for correct billing and budgeting
  • Discuss strategies for partnering with industry funders in order to financially support IIT endeavors
  • Discuss recent changes to the Final Rule offering suggestions on how to implement compliant change

1.5 CRS credit hours

Click here to register via My Compass