Baltimore Washington Chapter: ACRP Baltimore Washington Chapter Meeting
Quynh-Van Tran, PharmD, BCPP, RAC
Team Leader, Good Clinical Practice Compliance Oversight Branch
Division of Clinical Compliance Evaluation
Office of Scientific Investigations
Office of Compliance
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
This presentation will focus on the FDA BIMO inspection of clinical investigators and include discussion of following topics: regulatory responsibilities of the clinical investigators in conducting clinical trials, what to expect during and after the inspection, FDA Form 483, adequate and inadequate response to the FDA Form 483, trends and common deficiencies found in FDA BIMO clinical investigator inspection.Learning Objectives
Upon completion of this presentation, participants should be able to:
- Discuss the regulatory responsibilities of the clinical investigator in conducting clinical trials.
- Understand the goals of FDA BIMO clinical investigator inspection, and what to expect during and after the inspection.
- Identify key strategies for responding to Form FDA 483.
- Identify recent trends and common deficiencies found in CDER’s BIMO inspection of clinical investigators.
1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.To receive contact hours:
Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.Purchase contact hours hereContact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members