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.