Education & Training
Training on the foundations of HEOR and HCEI and PIE communications
The client was facing barriers in the materials they were able to get approval for as well as the speed at which they were able to get approval.
The client needed to educate their regulatory and legal colleagues on foundational HEOR concepts which they would be reviewing, the regulatory landscape and FDA interpretations of HCEI and PIE communications, as well as a refresher on their approval process.
AESARA provided educational seminars in three phases.
These seminars began with the foundations of HEOR, including topics such as observational study design, epidemiology, health economics, and economic modeling.
In the second phase, we focused on educating participants about the current regulatory/ legal landscape surrounding healthcare economic information (HCEI) and preapproval information exchange (PIE), as well as the most recent FDA interpretations of the statutes and legislation.
Finally, these seminars concluded with training on the best practices for reviewing these materials, an exploration of peer companies’ approaches, and a deep dive into the client’s current processes and pain points.
- Enabling Activity
Training development & delivery
Global Head of HEOR
The client developed a new approval process for different material types, ensuring a streamlined and efficient review process
The regulatory and legal teams gained the necessary competence and confidence to review HEOR materials effectively and per the current legal requirements
The client’s HEOR and payer marketing teams were able to approve key communication materials and present to payers in a timely fashion, increasing the likelihood of favorable market access