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

Price: $1,500.00

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Terms & Agreement:*

Terms and Agreement *

This program and all materials supporting the program are intended for educational purposes only. They are not intended to provide legal, regulatory or risk advice or guidance regarding any specific situation or scenario and are not a substitute for the advice of your advisors on specific issues. This material is based on the laws and regulations and DDMAC/OPDP/APLB enforcement letters in place at the time of the presentation and reflects the individual opinions of Lucy Rose and Associates, LLC.

Because regulations change and risk evaluation is a subjective matter, the information and opinions provided and expressed as part of the program should not be relied upon for decision-making purposes. Further, Lucy Rose and Associates, LLC does not warrant or guarantee that you or your employer or any of its employees or contractors, by relying on the educational materials provided by the program, would not be subject to regulatory or legal enforcement actions. This material is copyrighted ; it or any part of it may not be photocopied, reproduced, disseminated ,or otherwise used by anyone other than Lucy Rose and Associates, LLC without the express written prior authorization of Lucy Rose and Associates, LLC.

Each individual paid registration is for one attendee. The program may not be shared with anyone other than a paid registrant either during its live presentation or in any recorded format. The program or any part of it may not be recorded or reproduced in any format including but not limited to: video, photographs, screen shots, audio recordings or by any other mechanism in existence now or in the future capable of reproducing or transmitting the program in whole or in part.

I have read and agree to the terms above.