This two-day seminar was designed for those who desire an overview of the drug/biologic approval process, the regulations that govern IND studies, the CRA's role in monitoring, and the FDA's role in auditing. It consists of a comprehensive review of the GCP obligations of the sponsor and the investigator, the FDA Guidance: Investigator's Supervisory Role, the regulations governing human subject protection, and a review of the similarities and differences between the FDA regulations and the ICH GCP (E6) guideline. It also reviews the key documents and elements of the clinical investigation at the site level, including the Investigator Study File and the Sponsor's Trial Master file, as well as all the report requirements and the reporting timeframes. MRM provides each participant with CD-ROM Regulatory Reference.

• List the sponsor's, investigator's and IRB's responsibilities with investigational drug/biologic studies.
• Discuss an overview of the monitoring activities performed for an investigational drug/biologic study.
• Identify adverse and serious adverse event assessments, documentation, and reporting requirements.
• Discuss the differences between the IND Application versus the NDA and BLA.
• Recognize the purpose of the FDA BIMO Inspection program.

Day 1

I. Overview of the Drug/Biologic approval Process

• IND Submission and key content
• Phases of Research
• NDA Submission and Key Content
• BLA Submission and Key Content

II. FDA GCP & ICH GCP

• FDA Guidance: Investigator Supervisory Role, Oct 2009
• FDA GCP: Sponsor Obligations 21CFR312
• ICH GCP (E6) Section 5: Sponsor
• FDA GCP: Investigator Obligations 21CFR312
• ICH GCP (E6) Section 4: Investigator
• Financial Disclosure
• Electronic Records and Signatures
• FDA Form 1572 "Statement of the Investigator"
• Essential Documents: TMF and the ISF
• Study Drug Accountability
• Protocol and the Investigator Brochure

Day 2

III. Adverse Events

• Serious Adverse Events vs. Non-Serious Adverse Events: Recognizing and Reporting
• IND Safety Reports and SUSARS
• AE Drill Exercise

IV. Protection of Human Subjects

• Data Safety Monitoring Board
• IRB Role and Responsibility
• Informed Consent & Assent & Legal Authorized Representatives
• HIPAA: Research Authorization
• Informed Consent Compliance Drill

V. Monitor Role and Responsibilities

• Monitoring Visit Types & strategies for Effective Visits
• Monitoring Responsibilities and Techniques
• MRM Step Monitoring Method, the 8 R’s to Consent GCP Compliance Verification, the 5 R’s to HIPAA Compliance Verification
• Monitoring Plan Content and Documentation

VI. FDA's Bioresearch Monitoring Program (BIMO)

• BIMO Program Objective and Function
• What Happens During an Audit?
• Typical FDA Audit Findings and their Classification
• What is Fraud and Misconduct?

CRA's and other Drug/Biologic Industry professionals who want to gain knowledge about the drug/biologic approval process, GCP governing IND studies and the monitoring role.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations Ask About Student Discount (Availability limited)

Florida State Provider #50-11408, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 11 contact hours. Credits can be applied to ACRP certification.

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.