Baltimore Washington Chapter: ACRP Baltimore Washington Chapter Meeting

When:  May 30, 2019 from 5:45 PM to 8:30 PM (ET)

Baltimore Washington Chapter: ACRP Baltimore Washington Chapter Meeting

Purchase contact hours here

Speaker Name
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

Target Audience
  • CRCs
  • CRAs
  • Investigators
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Medical Monitor, Medical Officer, Project Physician
  • Quality Assurance
  • Clinical Research Administrators
Program Description
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:
  1. Discuss the regulatory responsibilities of the clinical investigator in conducting clinical trials.
  2. Understand the goals of FDA BIMO clinical investigator inspection, and what to expect during and after the inspection.
  3. Identify key strategies for responding to Form FDA 483.
  4. Identify recent trends and common deficiencies found in CDER’s BIMO inspection of clinical investigators.
Contact hours: 2.0 Contact hours have been approved 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 here

Contact Hour Cost:
  • $0 Chapter Members
  • $15 ACRP Members
  • $30 Non-Members
Refund Policy: Not applicable

Location

Center for Life Sciences Shady Grove (near Shady Grove Hospital)
9714 Medical Center Drive
Rockville, MD 20850
Online Instructions:
Url: http://zoom.us/j/3861000999
Login: One tap mobile +16699006833,,3861000999# US (San Jose) +14086380968,,3861000999# US (San Jose) Dial by your location +1 669 900 6833 US (San Jose) +1 408 638 0968 US (San Jose) +1 646 876 9923 US (New York) Meeting ID: 386 100 0999 Find your local number: https://zoom.us/u/azlli2HZl