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INTRODUCTION TO THE FOOD AND DRUG ADMINISTRATION

INTRODUCTION TO THE FOOD AND DRUG ADMINISTRATION

UPCOMING DATES:

  • NO UPCOMING PUBLIC COURSES

Join us for an intensive and interactive one-day Introduction to the Food and Drug Administration course, limited to 25 people to create a safe environment and maximize personal engagement. This is an ideal orientation course for all new employees interacting with the differing aspects of FDA regulation. Understanding the organizational structure and regulation practices of the FDA is essential to comprehending the “why” behind your work contributions, how every piece of your work relates to the big picture for your organization, and how to maximize your work in relationship to others – both internally and externally.
 
 Examples of topics to be covered in this course:

  • Food and Drug Administration History
  • FD&C Act
  • Organizational Structure
  • Interactions with other government agencies and with international regulatory agencies
  • Specifics of FDA regulatory oversight
  • Drug Development Overview by Phases (all phases, IND, NDA, etc.)
  • Maximizing meetings with FDA (special emphasis on end of phase II meetings)
  • Drug Review Process 
  • PDUFA, FDAMA, FDAA
  • Advertising/Promotion requirements and review process
  • Drug Safety considerations
  • Manufacturing and Inspections (including international offices)
  • Insights on working with FDA

This course is designed for all disciplines and from all industries who are impacted, either directly, or indirectly, by FDA regulation. Examples include:
 
Disciplines: Clinical, Regulatory, Legal, Medical, Marketing, Sales, Advertising, Administration, Project Management, Sales Training, Compliance, Trial Designers, Communications, Forecasters, etc.
 
US and International Businesses, Societies and Institutions: Pharmaceutical, Biotech, Medical Devices, Veterinary Medicine, Advertising Agencies, Public Relations Firms, Clinical Trial Firms, Insurance, Payers, Medical Societies, Academic Institutions, etc.

 

Philadelphia Downtown Marriott Courtyard

21 N Juniper Street

Philadelphia, PA 19107

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