Code & Guidance Update 2024

New guidance on RWE, 
disease burden, and duration

This training has been created based on industry feedback relating to the recent code updates on RWE, presentation of burdens of a disease, and study duration.

Jennifer Carroll, Director of Communications, PAAB

Course format

  • 3 x eLearning modules
  • 1 x live 60 minute Q&A webinar (May 23, 10-11am EDT) + event recording
  • Bite-size videos containing detailed examples based on real life examples
  • Certification of completion*


*You must attend the live Q&A or view the recording, in order to receive the certificate and LinkedIn badge.

Training Outcomes

Training Outcomes

1
RWE

Learn how to effectively apply the "PAAB Attention Icon Guidelines" to enhance your advertising practices with evidence-based information.

2
Study Duration

Dive into the intricacies of clinical trial duration with training based on the comprehensive guidance document "Guidance on Study Duration."

3
Burdens of Disease

Review of new guidelines to help you establish effective strategies for balancing utility and credibility of disease burden in future advertising content.


Study Modules

Course Modules



1 Real World Evidence

Compliantly Present Real-World Evidence in Future Materials

Learning Objectives
  • Obtain the skills to present Real World Evidence effectively and in compliance with the latest guidelines.
  • Gain a comprehensive understanding of when and how to use the attention icon including for open-label RCTs with subjective endpoints or studies with formulations from other jurisdictions.
  • Understand how to balance informative content with regulatory requirements.


2 Guidance on Study Duration

Learning Objectives
  • Understand the critical requirements for advertising claims supported by clinical trials, including consistency with Terms of Market Authorization (TMA).
  • Explore how to leverage out-of-label studies and pre-planned extensions in clinical trials to support advertising messages.
  • Discover how to effectively include necessary disclosures in the Advertising/Promotion System (APS) to maintain transparency and compliance.


3 Presentation of Burdens of Disease in Advertising

Learning Objectives
  • A comprehensive walkthrough of the “Guidance on the Presentation of Burdens of Disease in Advertising" to elevate your skills in applying the updated guidance.
  • Understand the distinction between disease information and product information in ads.



Certificate & LinkedIn Badge

Showcase your understanding of the PAAB code

Demonstrate that your PAAB knowledge is up to date

Certification achieved by students who pass ALL final quizzes in the course

*Badges provided by a third party provider, Credly, and sync directly to your LinkedIn once your account has been created.

Questions


Questions? Please email Jennifer Hamilton on [email protected]