Navigating Medical-Regulatory-Legal Review

Based on success negotiating approval of hundreds of training pieces with medical-regulatory-legal (med-reg-legal) review committees, Dawn Luna and Ann Hill will share strategies to navigate the med-reg-legal review process (MRL), including (1) recognizing the value of the MRL role; (2) building strong relationships with MRL reviewers; (3) incorporating the MRL perspective at the design stage; (4) communicating effectively with MRL teams; and (5) negotiating compromises that meet the needs of your entire organization—including trainers and learners.

You’ll leave this session with tips and solid strategies for navigating MRL review at each stage of the training development process.

[NOTE: The Session length below should be 20 minutes for a Learning Lab.]

  • Date:Wednesday, June 5
  • Time:12:30 PM - 12:50 PM
  • Room:Learning Lab 3 - Longhorn D
  • Location:Learning Lab 3 - Longhorn D
  • Session Type:Learning Labs
  • Submitter Name: Hill, Ann
  • Submission Date (CST): 09/01/2019 22:57
  • Session Level: Beginner
  • Submitter Email:
  • Session Length: 20 Minute Micro-Learning
  • How are you planning on keeping the learners engaged during this presentation?: Engaging stories and discussion about the future evolution of the FDA.
  • Learning Objective 1: Recognize the value of the med-reg-legal review
  • Learning Objective 2: Communicate effectively with med-reg-legal reviewers
  • Learning Objective 3: Negotiate compromises during med-reg-legal review that meet the needs of your entire organization—including trainers and learners
  • What is the topic your workshop will cover and how is it relevant to the industry?: The FDA influences all life sciences companies
Ann Hill
Alphie Training
Dawn Luna
Amgen Inc