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Designed for those who desire an understanding of the drug/biologic approval process, the regulations that govern IND studies, and the CRA's role in monitoring these studies. The course provides a solid overview of the drug/biologic development process, presenting GCP obligations of the sponsor, investigator, and IRB together with a review of the regulatory documents, study documents, and drug accountability. A comprehensive review of the roles and responsibilities of the monitor and the types of site visits will be discussed, along with an example of FDA audit findings.
Daily Agenda / Course Topics
| 1 |
Overview of the Drug/Biologic approval Process |
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IND Submission and key content |
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Phases of Research |
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NDA Submission and Key Content |
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BLA Submission and Key Content |
| 2 |
FDA GCP & ICH GCP |
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FDA GCP: Sponsor Obligations 21CFR312 |
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ICH GCP (E6) Section 5: Sponsor |
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FDA GCP: Investigator Obligations 21CFR312 |
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ICH GCP (E6) Section 4: Investigator |
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Financial Disclosure |
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Electronic Records and Signatures |
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FDA Form 1572 “Statement of the Investigator” |
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Essential Documents: TMF and the ISF |
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Study Drug Accountability |
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Protocol and the Investigator Brochure |
| 3 |
Adverse Events |
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Serious Adverse Events vs. Non-Serious Adverse Events: Recognizing and Reporting |
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IND Safety Reports and SUSARS |
| 4 |
Protection of Human Subjects |
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Data Safety Monitoring Board |
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IRB/IEC |
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Informed Consent |
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HIPAA: Research Authorization |
| 5 |
Monitor Role and Responsibilities |
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Regulatory Obligation |
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Overview of Monitoring and Visit types |
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Defining the Monitoring Plan |
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Monitoring Responsibilities |
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Monitoring Documentation |
| 6 |
FDA's Bioresearch Monitoring Program (BIMO) |
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BIMO program Objective and Function |
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What happens during an audit? |
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FDA audit finding classification |
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Recent Monitoring Warning letters |
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Recent Research Site Warning Letters |
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