Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. This course also provides the basics of regulatory strategy in biopharmaceutical development examining the various regulatory pathways. Through lectures, case studies, and hands-on exercises, students gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S. and other countries, and how regulatory approval processes affect corporate strategy. The requirements and logistics of regulatory submissions will also be explored.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe the relevant regulations involved in biopharmaceutical product development.
• Discuss how companies devise development strategies and the impact of the regulatory requirements on these decisions.
• Explain how the multidisciplinary requirements for biopharmaceutical product development and its impact on strategic development decisions.
• Identify the key considerations required for successful biopharmaceutical product development.

Topics Include

• The IND Phase
• The License Application Phase
• Pediatric Regulations
• Regulatory Development Strategy

Notes

STUDENTS: if you have taken and passed REGL.x403, you do not have to take REGL.x411 under the updated / new requirements for Track 1. REGL.x411 incorporates content that was in REGL.x403 and REGL.x406.