Fall 2007: W4200 Section
001 : BIOPHARMACEUTICAL DEVELOPMENT & REGULATION
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