ALS 463
Current Issues for FDA Regulated Products

The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires that professionals have a good working knowledge, background and understanding of the role regulatory strategy plays in effective product development.

After completing the course, students should be able to:

1. Describe the role played by a regulatory strategist in a cross-functional medical product development team.
2. Identify the primary elements that comprise a regulatory strategy for a medical product.
3. Critically evaluate a drug development plan and identify regulatory gaps.
4. Describe the importance of, and methods for gathering, regulatory intelligence.
5. Apply the critical thinking skills necessary to make regulatory strategy-related decisions.
6. Interpret relevant regulations and guidances and apply them to medical product development.