Southern California Chapter: FDA - A Fee for Service Agency: The status of a user fee

FDA - A Fee for Service Agency: The status of a user fee

Speakers:
Dr. Michael Hamrell, MORIAH Consultants

Program Agenda:

• 5:00 - 5:30pm Registration
• 5:30 - 6:15pm Dinner
• 6:15 - 6:30pm Introduction
• 6:30 - 7:30pm Speech
• 7:30 - 8:00pm Question & Answer
• 8:00pm Meeting Adjourn

Program Description: In the past 25 years the FDA has evolved from a taxpayer supported organization to a fee for service agency. Companies working with FDA on regulated products need to plan for submission and annual fees to their their products approved and keep their products on the market. This had become another cost of doing business in the drug/device industry.

Upon completion of this Seminar, attendees should be able to:

• Describe the role of user fees at FDA
• Understand how user fees play a role in FDA workload
• Explain how user fees can impact a company's interaction with FDA

Target Audience: CRAs, CRCs, Nurses, Coordinators, Clinical Trial Assistants

Registration Cost: FREE to all Chapter, ACRP, and non-members

Contact hours: 1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.

To receive contact hours: Sign in at the event, attend the program. The Southern California Chapter Board will email you when registration and contact hour purchase is available via ACRP website.
Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:

• $0 Chapter Members
• $15 ACRP Members
• $30 Non-Members

Refund Policy: Not applicable

Level: Not specified