Course Description | Instructor Information | Biotech Home

Overview

This course provides an in-depth study of the regulatory framework required to achieve approval of new products derived through biotechnology.

The course will include class lectures and short research projects. Discussion of current reference articles and case studies will also be included. A final exam and project papers will be required for credit students.

Lecture Topics

• Introduction to the Regulatory Approval Process; Overview of the FDA
• Investigational New Drug Application (IND); Summary of regulations and guidelines
• Introduction of cGMP's/principles of validation
• Introduction to QA/QC principles
• Good Laboratory Practice (GLP) compliance
• Pre-clinical testing for biotechnology products; safety and toxicology
• Clinical stages, design of clinical trials and protocols, evaluation of clinical data
• Regulatory Filings: Biological License Application (BLA)
• Pre-approval inspections
• Team Biologics
• International regulatory status for biotechnology products; WHO, Japan, and the EC/CPMP application
• International Conference on Harmonization (ICH) update
• Regulatory considerations for gene therapy and transgenic products

Who should attend

• Biotechnology professionals/biochemical engineers
• Industrial and government researchers
• Faculty and graduate students (engineering, chemistry, biology and pharmacy)
• Entrepreneurs, lawyers, patent attorneys with interests in biotechnology
• Architects and engineers
• Regulatory affairs professionals
• Quality control/quality assurance professionals

Price: $1,195.00

Locations: Live Lecture at UMBC Main Campus and Distance Learning lectures downloaded online.

Registration

• Click here to download and complete the registration form to mail in or fax
• Click here to request additional information or to be added to the interest list for this course.