2016 Clinical Investigator Training Course

Clinical Investigator Training Course November 7 - 9, 2016
Location: Silver Spring Civic Building at Veterans Plaza
8525 Fenton Street, Silver Spring, MD 20910

Download the Full Agenda (PDF)

Description

The Clinical Investigator Training Course is designed for physicians, nurses, pharmacists and other healthcare professionals involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the scientific, regulatory and ethical aspects of clinical trials. They also include discussions of non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA regulatory requirements related to the performance and evaluation of clinical studies.

Target Audience

This activity is intended for physicians, pharmacists, nurses, researchers and others who are responsible for the conduct of clinical trials.

 

View the corresponding slides for each of the featured topics below:

 

Monday, November 7th

Session 1: The Clinical Trial Protocol

 

8:20 - 8:30 a.m.

Course Overview

Leonard Sacks, M.D. (CDER)

8:30 - 9:00 a.m.

FDA Structure and Mandate

Leonard Sacks, M.D. (CDER)

9:00 - 10:00 a.m.

The Design of Clinical Trials (Part I)

Robert Temple, M.D. (CDER)

10:00 - 10:15 a.m.

Break

 

10:15 - 10:45 a.m.

The Design of Clinical Trials (Part II)

Robert Temple, M.D. (CDER)

10:45 - 11:00 a.m.

Discussions/Questions

Robert Temple, M.D. (CDER)

11:00 - 11:30 a.m.

Clinical Trial Endpoints

Eugene Sullivan, M.D.
(Insmed, Inc., & Principal, EJS Consulting, LLC)
Not offered for CE
 

11:30 - 12:00 p.m.

Issues in Clinical Trial Designs for Devices

Owen Faris, Ph.D. (CDRH)

12:00 - 1:00 p.m.

Lunch

 

1:00 - 1:30 p.m.

Issues in Clinical Trial Design for Companion Devices

Hisani Madison, Ph.D., M.P.H. (CDRH)

1:30 - 2:00 p.m.

Issues in Clinical Trial Design for Rare Diseases

Jonathan Goldsmith, M.D. (CDER)

2:00 - 2:45 p.m.

Informed Consent and Ethical Considerations in Clinical Trials

Christine Grady, R.N., Ph.D. (NIH)

2:45 - 3:00 p.m.

Discussion/Questions

Hisani Madison, Ph.D., M.P.H.
Jonathan Goldsmith, M.D.
Christine Grady, R.N., Ph.D.

3:00 - 3:15 p.m.

Break

 

3:15 - 3:45 p.m.

Safety Considerations in Phase 1 Trials

Sumathi Nambiar, M.D. (CDER)

3:45 - 4:15 p.m.

Safety Assessment in Clinical Trials and Beyond

Yuliya Yasinskaya, M.D. (CDER)

4:15 - 4:45 p.m.

Special Cardiac Safety Concerns

Shari Targum, M.D. (CDER)

4:45 - 5:15 p.m.

Drug Induced Liver Injury (DILI)

Mary Ross Southworth, Pharm.D. (CDER)

5:15 p.m. - 5:30

Discussion/Questions

Sumathi Nambiar, M.D.
Yuliya Yasinskaya, M.D.
Shari Targum, M.D.
Mary Ross Southworth, Pharm. D.

 

 

 

Tuesday, November 8th

Session 2: FDA and the Regulation of Clinical Trials

 

8:30 - 9:00 a.m.

FDA Perspective on International Studies

Kassa Ayalew, M.D., M.P.H. (CDER)

9:00 - 9:45 a.m.

Good Clinical Practice (GCP) Key Topics

Bridget Foltz, M.S. (OC)

9:45 - 10:15 a.m.

Investigator Responsibilities – Regulation and Clinical Trials (Part I)

Cynthia Kleppinger, M.D. (CDER)

10:15 - 10:30 a.m.

Break
 

 

10:30 - 11:00 a.m.

Investigator Responsibilities – Regulation and Clinical Trials (Part II)

Cynthia Kleppinger, M.D. (CDER)

11:00 - 11:30 a.m.

Electronic Technologies in Clinical Trials (Sacks)

Electronic Technologies in Clinical Trials (McNeilly)

 

Leonard Sacks, M.D. (CDER) Patrick McNeilly, Ph.D. (OC)

11:30 - 11:45 a.m.

Discussion/Questions

Kassa Ayalew, M.D., M.P.H.
Bridget Foltz, M.S.
Cynthia Kleppinger, M.D.
Leonard Sacks, M.D.
Patrick McNeilly, Ph.D.

11:45 - 12:45 p.m.

Lunch

 

 

Session 3: Understanding the Investigator Brochure – Non-Clinical and Phase 1 Studies

 

12:45 - 1:15 p.m.

QMC and the Investigator Brochure (Drugs): Ensuring the Quality of a Drug used in a Clinical Trial

Dorota Matecka, Ph.D. (CDER)

1:15 - 1:45 p.m.

Biosimilar Biological Products

Sue Lim, M.D. (CDER)

1:45 - 2:30 p.m.

Pharmacology/Toxicology in the Investigator Brochure

Brenda Gehrke, Ph.D. (CDER)

2:30 - 2:45 p.m.

Discussion/Questions

Dorota Matecka, Ph.D.
Sue Lim, M.D.
Brenda Gehrke, Ph.D.

2:45 - 3:00 p.m.

Break

 

 

Session 4: Early Clinical Studies Session

 

3:00 - 3:30 p.m.

Clinical Pharmacology 1: Phase 1 Studies and Early Drug Development

Shirley Seo, Ph.D. (CDER)

3:30 - 4:00 p.m.

Clinical Pharmacology 2: Clinical Considerations During Phase 2 and Phase 3 of Drug Development

Su-Young Choi, (CDER)

4:00 - 4:30 p.m.

Clinical Discussion of Special Populations

Zhixia (Grace) Yan, Ph.D. (CDER)

4:30 - 4:45 p.m.

Discussion

Shirley Seo, Ph.D.
Su-Young Choi, Pharm.D.
Zhixia (Grace) Yan, Ph.D.

 

 

 

Wednesday, November 9th

Session 5: Putting It All Together – IND/IDE Application and Compliance Issues Concurrent Breakout Sessions for Drugs/Devices/Biologics

 

Session 1A
8:30 a.m.–9:30 a.m.
Center for Drug Evaluation and Research

How to Put Together an IND Submission

Judit Milstein, B.Sc.(CDER)
Ei Thu Z. Lwin, Pharm.D. (CDER)

Session 1B
8:30 a.m.–9:30 a.m.

Center for Biologics Evaluation and Research
 
 
 
Donald Fink, Ph.D. (CBER-CMC)
Allen K. Wensky, Ph.D. (CBER-Preclinical)
Rachel Witten, M.D. (CBER-Clinical)

Session 1C
8:30 a.m.–9:30 a.m.

Center for Devices and Radiological Health
Nilsa Loyo-Berrios, Pharm.D. (CDRH)
Benjamin Eloff, Ph.D.(CDRH) Veronique Li, B.S.E., M.B.A. (CDRH)

9:30 - 9:45 a.m.

Break

 
Session 2A
9:45 a.m.–10:45 a.m.
Center for Drug Evaluation and Research
Repeat of Session 1A
Judit Milstein, B.Sc. (CDER)
Ei Thu Z. Lwin, Pharm.D. (CDER)
Session 2B
9:45 a.m.–10:45 a.m.
Center for Biologics Evaluation and Research
Repeat of Session 1B
Donald Fink, Ph.D. (CBER-CMC)
Allen K. Wensky, Ph.D. (CBER-Preclinical)
Rachel Witten, M.D. (CBER-Clinical)
Session 2C
9:45 a.m.–10:45 a.m.
Center for Devices and Radiological Health
Repeat of Session 1C
Nilsa Loyo-Berrios, Pharm.D. (CDRH)
Benjamin Eloff, Ph.D.(CDRH) Veronique Li, B.S.E., M.B.A. (CDRH)

10:45 - 11:15 a.m.

Clinical Investigator Site Inspections-What to Expect

Patricia Holobaugh, M.S. (CBER)

11:15 - 11:45 a.m.

Panel Discussion

Patricia Holobaugh, M.S. (CBER) Irfan Khan, M.S. (CDRH) Constance Cullity, M.D. (CDER)

11:45 - 12:45 p.m.

Lunch

 

 

Session 6: Safety of Clinical Trials and Special Populations

 

12:45 - 1:30 p.m.

The Analysis of Investigator Data, Sources of Bias and Error

Susan Ellenberg, Ph.D. (University of Pennsylvania)

1:30 - 2:00 p.m.

Patient Engagement in Drug Development

Eleanor M. Perfetto, Ph.D, M.S. Patricia Furlong, B.S.N.
Steven Taylor, M.B.A.

2:00 - 3:00 p.m.

The Clinical Investigator's Role

Stephen N. Davis, M.B.B.S.
Shyamasundaran Kottilil, Ph.D., M.B.B.S.
Michael Terrin, M.D., C.M., M.P.H.
Maria Jison, M.D.
Not offered for CE

3:00 - 3:30 p.m.

Explain Evaluation Process, Wrap up and Adjourn

Leonard Sacks, M.D. (CDER)