UNDERSTANDING THE INNER WORKINGS OF THE FDA (1 Day)

UPCOMING DATES:

  • 10/4/22

FOR US AND EX-US LIFE SCIENCES PROFESSIONALS

This is a Comprehensive Introductory Course for all life science and health care professionals, working anywhere in the world, with a need for a basic understanding of the FDA through the lens of prescription drug/biologics development and oversight. As a former FDA senior official, the director of both CDER’s Office of Training and Communications and what is now the Office of Prescription Drug Promotion -  (OPDP), I am excited to share facts and insights into the inner workings of the FDA.

Course Description:

This course is designed to serve as the foundational course for all professionals, anywhere in the world, with a need for a basic understanding of the FDA through the lens of prescription drug development and oversight. Examples of those professionals include, but are not limited to -  those new to the life sciences industry, those involved in academic research or professionals in related government organizations, and health care professionals with a desire to better understand FDA’s:

  • Organizational structure and processes
  • Operational workings and processes
  • Professional Roles and responsibilities
  • Role in drug development and industry interactions and opportunities


Topics include, but are not limited to:

  • FDA History – why founded, mission then and now
  • FDA’s interaction with other government health and enforcement agencies
  • Pertinent Laws, Guidances, and Regulations
  • Organizational Structure and operations
  • Responsibilities and Authorities
  • Professional Disciplines and Roles in the review process and product maintenance
  • How FDA works with external stakeholders (advisory committees, professional organizations, consumer groups, other governmental agencies, etc.)
  • Communicating with FDA for maximum impact
  • Basic understanding of drug development
  • Basic understanding of FDA’s role in drug development (submission requirements, review times, PDUFA, meetings, review, etc.) and interactions with industry/sponsors
  • Basic understanding of the advertising/promotion regulations

 

Participants may NOT receive a refund for any reason (unless LRA cancels course). If the participant cannot attend the course they may send a substitute. Course registration may be transferred to another participant at any time by notifying lucyrose01@aol.com prior to the start of the course.

Price: $1,500.00

REGISTER NOW

To register, please fully complete the registration form below, including checking the box agreeing to the terms, then click submit. 






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.

Copyright 2022 by Lucy Rose and Associates, LLC.  All rights reserved.