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Introduction to Regulatory Affairs and Compliance for Drugs Biologics and Medical Devices

A required course in the Certificate Program in Regulatory Affairs and Compliance.

Course Description

This course presents an introduction to the field of regulatory affairs and to the laws and regulations governing healthcare products, including drugs, biologics, dietary supplements, and medical devices. Individuals from various disciplines who are new to the field of regulatory affairs will explore the regulatory pathways for each of these medical products and learn how to maintain regulatory compliance with U.S. regulations throughout the product lifecycle. Examine the structure of the FDA and the historical context of current FDA regulations governing healthcare products. Appreciate the complexities of global regulatory affairs through an introduction to the regulatory structure in the European Union. This course provides an introduction to the regulatory affairs profession and provides a framework for subsequent courses in the Regulatory Affairs and Compliance Certificate Program.

  • Details
  • $735
  • September 20, 2021 to November 28, 2021
  • Delivery Mode: Online
  • Reg#: 00203
  • ID/Units: PHRMSCI X480  (2.00)
    ( Section 1 )
  • Quarter: FALL 2021

Instructor


Pukar Ratti, MSChE, MSHCM, CIM, CCRP, FACMPE, is the Executive System Director of Research at CHRISTUS Health in Dallas area. Prior to that, he has worked as Director of Clinical Research and Biobank at Ochsner Health System in New Orleans, and the Department Head of the Office of Research & Sponsored Projects at Leonard J. Chabert Medical Center, part of the Louisiana State University Health System. Pukar has over 15 years of combined experience in Research Administration, Clinical Research, Pre-clinical/Basic Science Research, Behavioral Research, Clinical Research Revenue Cycle, Project Management, IRB services, Contract negotiations, Student Mentorship, Operational Redesign, Grants Portfolio Management, Policy-making, Personnel Development, Strategic Planning, Biobanking, etc. Today, Pukar is one of the few medical professionals in the State of Texas to have earned the prestigious title of Fellow of American College of Medical Practice Executives.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START09/20/2021Monday------Online (Access Begins)---
END11/28/2021Sunday------Online (Access Ends)---