Meets: Thursday 2:40pm-4:40pm


Location: 1000 Sherman Fairchild Life Sciences Building


Instructors: Ron Guido, Alan McEmber


Instructor Contact : ron.guido@pfizer.com; alan.mcember@pfizer.com


Course Description


The program aims to provide current life sciences students with an understanding of what drives the regulatory strategies that surround the development decision making process, and how the regulatory professional may best contribute to the goals of product development and approval. To effect this we will examine operational, strategic and commercial aspects of the regulatory approval process for new drug, biologic and biotechnology products both in the United States and worldwide.  The topics are designed to provide a chronological review of the requirements needed to obtain marketing approval.  Regulatory strategic, operational, and marketing considerations will be addressed throughout the course. We will examine and analyze the regulatory process as a product candidates are advanced from Research and Development, through pre-clinical and clinical testing, to marketing approval, product launch and the post-marketing phase.  The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in the pharmaceutical or biotechnology industry. Worked examples will be explored to illustrate complex topics and illustrate interpretation of regulations


Class Modules


  • History of Regulation (incl. Regulatory Defined, Major Regulatory Bodies Worldwide)
  • Basics of Drug Discovery and Development
  • Pharmacokinetics / Pharmacodynamics (from a Regulatory viewpoint)
  • Non Clinical Pharm/ Tox (incl. cGMP)
  • Standards of Approval (Rx, OTC, Biologics, Biotech)
  • IND / CTD / CTx (inc. cGCP)
  • NDA / MAA (US, EU, Japan, National
  • Deep Dive US Regulatory
  • Deep Dive EU Regulatory
  • Clinical Program Development / Labeling Development and Revision
  • Post Approval Actions (Studies, Amendments, Supplements, Variations) EU / US
  • cGMP and Inspection
  • CM&C and Change Control
  • Recalls and Field Actions Product Queries
  • OTC / Consumer Products
  • Advertising and Promotion
  • Agency Meetings and Communication
  • Introduction to Regulatory Assessment and Strategy


Class days are:

9/6, 9/13, 9/20, 9/27, 10/4, 10/11, 10/18, 10/25, 11/1, 11/8, 11/15, 11/29, 12/6


Continuous Assessment: 3 Take Home (24-Hour) Assessments, 10 short responses per assessment. May require light research and problem solving


Textbook: Drug Discovery and Development: Technology in Transition

H.P. Rang

Churchill Livingstone (Elsevier)

ISBN-10: 0443064202

Available in most online bookstores


NOTE: Supplemental readings will be posted