APFM Section 1 Module 4: Regulatory and Legal Considerations
Module Description
Understanding regulatory and legal considerations is a large part of developing and maintaining a formulary. This module will explore the FDA approval process, patents, and how various regulatory bodies impact different lines of business. In addition, this module will review the regulatory landscape and legislative mandates and considerations for ensuring compliance and mitigating risks associated with formulary decisions.
Target Audience
Pharmacists, Pharmacy Technicians, Managed Care Professionals
Learning Objectives
At the completion of this activity, participants should be able to:
- Summarize how the FDA drug approval process and patents impact formulary decision-making.
- Discuss the role and impact of various regulatory bodies on different lines of business.
- Describe the regulatory landscape and legislative mandates related to drug pricing, reimbursement, and formulary management strategies.
Faculty:
Lisa LeGette, MBA, RPh
Senior Director, Government Affairs
Express Scripts
Danilo Trivic, PharmD
Director, Pharmacy Formulary Management
Centene Pharmacy Services
Financial Relationship Disclosures:
Faculty/Reviewer/Planner | Reported Relevant Financial Relationships |
Lisa LeGette Faculty | Evernorth Health Services, PBM |
Danilo Trivic, PharmD Faculty | Centene, Employer |
- AMCP Staff have disclosed no relevant financial relationships.
- If applicable, relevant financial relationships have been mitigated and documented.
- Content has undergone a peer review to ensure content validity.
Accreditation:
ACPE UAN:0233-0000-23-026-H04-P • Activity Type: Knowledge-Based
Contact Hours: 0.75
Release Date: August 04, 2023 • Expiration Date: July 31, 2026
CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.
To receive credit for an online activity you must:
- Review the full content of the activity.
- Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
- Complete a specific activity evaluation.