UNDERSTANDING REGULATORY DUE DILIGENCE FOR PHARMACEUTICAL AND BIOLOGICS COMPANY TRANSACTIONS
This course discusses some of the key legal and regulatory issues to evaluate, questions to ask, and documents to review in mergers, acquisitions, investments, financings, and other transactions involving pharmaceutical or biological products.
This course addresses the following:
1) FDA Regulatory Due Diligence
2) Healthcare Fraud and Abuse, Anti-corruption, and Transparency Compliance
3) Compliance Program Development and Oversight Compliance Program Development and Oversight
4) Coding, Coverage, and Reimbursement
5) Government Enforcement, and
6) Key State Regulatory Issues.