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HOWARD UNIVERSITY, COLLEGE OF PHARMACY, OFFICE OF CONTINUING PROFESSIONAL EDUCTAION

CE PROVIDER WITH COMMENDATION

 
 

Clinical Trials Foundations and Best Practices Training-Day 2


Date: Apr 20, 2026 09:00 AM - 01:00 PM

Fee

$0.00

CE Hours

3.25

CE Units

0.325

Registration closes on Apr 30, 2026 10:00 PM

Activity Type

Knowledge

Target Audience(s)

Pharmacists

Accreditation(s)

Accreditation Council for Pharmacy Education
Accreditation Statement: Howard University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

 

Monitoring and safety reporting in Clinical Research
   

Objectives

  • Describe the purpose and methods of study monitoring, including risk-based monitoring approaches.
  • Define adverse events and identify associated reporting requirements in clinical trials.
  • Explain safety monitoring and risk management strategies used to protect participants and maintain regulatory compliance.

Speaker(s)/Author(s)

Sarah Shami, Pharm.D.

Activity Number

0010-9999-26-020-L05-P
Date: 04/17/26
Time: 10:25 AM - 11:00 AM

CE Hours

0.50
   

Mon, Apr 20, 2026
 

   

Objectives

  • Describe the phases of clinical trials (Phase I–IV).
  • Identify pharmacists’ roles in managing investigational drugs.
  • Explain pharmacists’ role in medication safety, protocol compliance, and adverse event reporting.

Speaker(s)/Author(s)

Bisrat Hailemeskel, B.Pharm., MSc, Pharm.D, ABAAHP
Professor & Vice Chair, Howard University College of Pharmacy

Activity Number

0010-9999-26-018-L05-P
Date: 04/20/26
Time: 09:05 AM - 09:50 AM

CE Hours

0.75
   

   

Objectives

  • Describe the principles of quality assurance in clinical trials.
  • Explain the importance of compliance with Good Clinical Practice (GCP).
  • Outline the difference between the roles of auditing and monitoring in clinical research.

Speaker(s)/Author(s)

Salome Weaver, Pharm.D., RPh., Associate Professo

Activity Number

0010-9999-26-019-L05-P
Date: 04/20/26
Time: 09:50 AM - 10:25 AM

CE Hours

0.50
   

   

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.

Activity Number

0010-9999-26-021-L05-P
Date: 04/20/26
Time: 11:00 AM - 11:40 AM

CE Hours

0.50
   

   

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

Activity Number

0010-9999-26-022-L05-P
Date: 04/20/26
Time: 11:40 AM - 12:30 PM

CE Hours

0.50
   

   

Objectives

  • Define the role and necessity of CAPA.
  • Identify corrective & preventive actions.
  • Recognize root cause analysis.

Speaker(s)/Author(s)

Sarah Shami, Pharm.D.

Activity Number

0010-9999-26-022-L05-P
Date: 04/20/26
Time: 12:30 PM - 12:50 PM

CE Hours

0.50