1 Facilitated by :- Dr. M.P. Venkatesh Assistant Professor Dept. of Pharmaceutics, Regulatory Affairs Group JSSCP, Mysuru Presented by :- Mr. Shankargouda R Patil 1 st M –Pharm Pharmaceutical Regulatory Affairs JSSCP, Mysuru 1 st EVALUATION SEMINAR Bioresearch Monitoring Program Internationalpharmaceutical regulation 1
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Facilitated by :-
Dr. M.P. Venkatesh
Assistant Professor
Dept. of Pharmaceutics,
Regulatory Affairs Group
JSSCP, Mysuru
Presented by :-
Mr. Shankargouda R Patil
1st M –Pharm
Pharmaceutical Regulatory
Affairs
JSSCP, Mysuru
1st EVALUATION SEMINAR
Bioresearch Monitoring Program
International pharmaceutical regulation 1
Introduction
Bioresearch Monitoring (BIMO) program is a
comprehensive program of on-site inspections and data
audits designed to monitor all aspects of the conduct and
reporting of FDA regulated research.
The BIMO Program was established to assure the quality
and integrity of data submitted to the agency in support
of new product approvals,
It also provides for protection of the rights and welfare of
the thousands of human subjects involved in FDA regulated
research
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It has become a cornerstone of the FDA
preapproval process for new medicines, medical
devices, food and color additives and veterinary
products introduced to the U.S. consumer
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BIMO Program Objectives
Protect the rights, safety, and welfare of
human research subjects
Assure the quality, reliability, and integrity of
data collected
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BIMO Program Functions
Audit clinical data
Inspect ongoing clinical research
Inspect nonclinical laboratories
Inspect Institutional Review Boards (IRBs)
Educate and train
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What may Prompt an Inspection of
Device Research?
New Product or Indication
New Technology
Complaints
History of non-compliance
Routine Surveillance
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BIMO Inspection Programs
Routine
– Surveillance
– Compliance follow-up
Directed
– Data audits of device submissions
For Cause
– Investigate problems
– Investigate complaints 7
Classification of inspection
NAI – No Action Indicated
The FDA field inspector did not identified objectionable
Practice (or) identify only minor issue that did not justify further action
VAI – Voluntary Action Indicated
Indicates that objectionable Practices were uncovered during that
inspection. But were not significant
OAI – Official Action Indicated
Inspection uncovered significant objectionable practices. Which
could affect data reliability (or) compromise human subject protection
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BIMO Compliance Programs
Clinical Investigators (CI)
Sponsors,
Contract Research Organizations, and
Monitors
Institutional Review Boards (IRB)
Good Laboratory Practices (GLP)
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Clinical Investigator (CI)
An individual who actually conducts a clinical
investigation, under whose immediate direction the