Introduction to Regulatory Affairs

The course is intended for practitioners, professional students, graduate students, and industry employees. You will have an opportunity to learn how consumer and  medical products are reviewed for safety and efficacy before they enter the marketplace and how these products are monitored when they do. The course is aimed at those with no prior knowledge of the discovery,  preclinical, or clinical regulatory affairs process for drugs, devices or biologics. An overview of the regulatory guidance for a product type will be clarified by using specific product examples.

Syllabus:

Monday, January 14:
Introduction and Overview of Course, Grading, Drugs, Devices, Biologics, and Food
Betsy Wattenberg and Mike Murphy

The Importance of Patents in Medical Product Development
Jim Ciapetta, Patent Counsel, Boston Scientific

Tuesday, January 15:
FDA - Organization, Inspection Practices, and Enforcement Actions
Tim Phillips, Compliance Officer, Office of Regulatory Affairs, Food and Drug Administration

Wednesday, January 16:
Animal Biologics
Kim Gugisberg, D.V.M., RLATG, CMAR, Assoc. Director of Quality Assurance for Bio R&D, Fort Dodge Animal Health

Melamine causes renal failure  – true or false.
Mike Murphy

Thursday, January 17:
PreClinical Drug Testing; Good Laboratory Practice (GLP), Cancer Drug Development, and Careers in Toxicology.
Andy Kiorpes, PhD, DVM, DABT, Director of Toxicology, MGI Pharma

Friday,  January 18:
Consumer Product Safety Commission and Federal Hazardous Substances Act/Proposition 65
Catherine F. Jacobson, 3M Corporate Toxicology and Regulatory Services

Monday, January 21:
Holiday, no class

Tuesday, January 22:
Animal Welfare & Institutional Animal Care and Use Committee (IACUC), Institutional Review Board, (IRB), Investigational Device Exemption (IDE's), Investigational New Drug (IND's) and Good Laboratory Practice (GLP) Audits
Dick Bianco, Director of Regulatory Affairs, University of Minnesota

Wednesday, January 23:
Neutraceuticals
Post Market Surveillance
Joy Frestedt, PhD, RAC, CCTI, Vice President, Clinical Affairs, BridgePoint Medical. Inc.

Thursday, January 24:
Food Animal Drug Development
Scott Brown, DVM, PhD, DCVCP, Senior Director, Metabolism & Safety, Pfizer Animal Health

Friday, January 25:
International Regulatory Issues
EU Regulations (specifically on MSDSs and product labeling), GHS (Globally Harmonized System of Classification and Labeling), and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals in Europe)
Ann Johnson, 3M Corporate Toxicology and Regulatory Services
 
Cost -  $800 for entire series or $95 per session. 20 CE credits.