ASPECTS OF REGULATORY HISTORY
A
COURSE
This course will provide an overview and summary of the regulatory history and requirements by the Food and Drug Administration (FDA) and
International Conference on Harmonization (ICH), which are necessary to ensure proper and successful clinical trial execution. This module is also
designed to take you through some of the history behind today’s system of drug and device development. It is important to provide you with this
perspective so that you can recognize how the industry and the FDA have evolved. Review of (ICH) will also provide you with an understanding of its
impact on the industry form a global perspective.
L FEATURED TOPICS
• Setting standards
• Organizations
• Regulations
• Guidelines
BASICS OF CLINICAL TRIALS
A
COURSE
The course discusses the different aspects of clinical investigation. It begins by defining the term “clinical trial” and exploring the history of clinical
trials. It examines the responsibilities of parties involved in clinical trials and the importance of clinical studies in the overall drug development. Next,
it outlines the different types of clinical studies and designs as well as the selection of study objectives, subjects, endpoints, methods to minimize bias,
control group and sample size. It provides the regulatory requirements and internationally accepted practices for the conduct of clinical trials. Lastly, it
concludes with the clinical trial registries and databases.
LEARNING OBJECTIVES
• Recognize historical milestones of clinical trials
• Clarify the roles and responsibilities of parties involved in clinical trials
• Identify clinical studies in the drug development process
• Understand the different types of clinical trial design
• Provide detailed information on the selection of study objectives, endpoints, subjects recruitment and sample size
• Outline the conduct of clinical trials
BIORESEARCH MONITORING PROGRAM (BIMO): INTRODUCTION
A
COURSE
This is the first in a series of courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used
in conducting and reporting Nonclinical Laboratory, Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence
Inspections. This course provides an overview and historical perspective of FDA’s BIMO program
L FEATURED TOPICS
• Evolution of FDA’s regulatory history
• BIMO terminology
• The purpose of FDA’s BIMO program
• Regulations and expectations that are part of FDA’s BIMO program
• How FDA implements the clinical BIMO program
