Clinical Trials Foundations and Best Practices Training-Day 2
Date: Apr 20, 2026 09:00 AM - 01:00 PM
Fee
$0.00
CE Hours
4.00
CE Units
0.400
Registration closes on Apr 30, 2026 10:00 PM
Activity Type
- Knowledge
Target Audience(s)
- Pharmacists
Accreditation(s)
Accreditation Statement: Howard University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Mon, Apr 20, 2026
Mon, Apr 20, 2026
Objectives
- Describe the phases of clinical trials (Phase I–IV) and their primary objectives in drug development.
- Identify the key roles and responsibilities of pharmacists in the management of investigational drugs during clinical trials.
- Explain the pharmacist’s role in ensuring medication safety, protocol compliance, and adverse event reporting in clinical research.
Speaker(s)/Author(s)
|
Bisrat Hailemeskel, B.Pharm., MSc, Pharm.D, ABAAHP
|
Date:
04/20/26
Time:
09:05 AM - 09:50 AM
CE Hours
0.50
Objectives
- List the quality control and monitoring vs. auditing.
- Define monitoring vs. auditing.
- Describe risk-based monitoring.
Speaker(s)/Author(s)
|
Celia J. Maxwell, MD |
Date:
04/20/26
Time:
09:50 AM - 11:00 AM
CE Hours
1.00
Objectives
- Describe FDA forms, IRB application, and Laboratory Certificates.
- Explain site selection visits, site initiations visits, and delegation of authority Log.
- Define advertising and recruitment, screening subjects, sponsors monitoring visits, and sponsor closeout visits.
Speaker(s)/Author(s)
|
Sarah Shami, Pharm.D. |
Date:
04/20/26
Time:
11:00 AM - 11:40 AM
CE Hours
1.00
Objectives
- Identify adverse event documentation for serious adverse events.
- Describe investigational product accountability, concomitant medication log, investigational new drug safety reports (INDs), and unanticipated problems involving risks to subjects or others (UPIRTOs).
Speaker(s)/Author(s)
|
Edward Bauer |
Date:
04/20/26
Time:
11:40 AM - 12:30 PM
CE Hours
1.00
Objectives
- Define the role and necessity of CAPA.
- Identify corrective & preventive actions.
- Recognize root cause analysis.
Speaker(s)/Author(s)
|
Sarah Shami, Pharm.D. |
Date:
04/20/26
Time:
12:30 PM - 01:00 PM
CE Hours
0.50