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Clinical Investigator
Training Course

November 7-9, 2016 | Silver Spring Civic Bldg.
8525 Fenton Street, Silver Spring, MD 20910
In-person attendance only!

Registration has now closed.
If you have registered and are no longer be able to attend, please email cersi@umd.edu so we can allow people on the waitlist to attend. If you are currently on the waitlist, we will contact you soon with a registration status update. Thank you for your patience.

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Details


This 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.

The Seventh Annual Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration and University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will be held from November 7-9, 2016 at the Silver Spring Civic Building at Veterans Plaza, 8525 Fenton Street, Silver Spring, MD 20910. 

** CME credit is being offered for this course.


Registration is now CLOSED.

 

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Learning Objectives

November
 
7th
 -
9th

Where

Learning Objectives


 • To identify important issues in the design, conduct and analysis of clinical trials.

 • To recognize the scope and limitations of preclinical information based on which human subjects are given investigational agents.
 • To apply the regulatory requirements for trials that are submitted to FDA.

Course Schedule

November 7-9, 2016 | Silver Spring Civic Bldg.
8525 Fenton Street, Silver Spring, MD 20910

RSVPs Closed
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Monday
November 7


7:30 am - 8:20 am

Registration and Distribution of Course Material


SESSION 1

THE CLINICAL TRIAL PROTOCOL


8:20 am - 8:30 am

Welcome/Introduction

Leonard Sacks, M.D. (CDER)

8:30 am - 9:00 am

FDA Structure and Mandate

Leonard Sacks, M.D. (CDER)

9:00 am - 10:00 am

The Design of Clinical Trials
Part I

Robert Temple, M.D. (CDER)

10:00 am - 10:15 am

Break


10:15 am - 10:45 am

The Design of Clinical Trials
Part II

Robert Temple, M.D. (CDER)

10:45 am - 11:00 am

Discussion/Questions

Robert Temple, M.D. (CDER)

11:00 am - 11:30 am

Clinical Trial Endpoints

Eugene Sullivan, M.D.

(EJS Consulting, LLC)

111:30 am - 12:00 pm

Issues in Clinical Trial Designs for Devices

Owen Faris, Ph.D. (CDRH)

12:00 pm - 1:00 pm

Lunch


1:00 pm - 1:30 pm

Issues in Clinical Trial Design for Companion Diagnostic

Devices

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

1:30pm – 2:00pm

Issues in Clinical Trial Design for Rare Diseasess

Jonathan Goldsmith, M.D. (CDER)

2:00pm – 2:45pm

Informed Consent and Ethical Considerations in Clinical

Trials

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

2:45pm – 3:00pm

Discussion/Questions

Hisani Madison, Ph.D., M.P.H. , Anne Pariser M.D., Christine Grady, R.N., Ph.D.

3:00 pm - 3:15 pm

Break


3:15pm – 3:45pm

Safety Considerations in Phase 1 Trials

Sumathi Nambiar, M.D. (CDER)

3:45pm – 4:15pm

Safety Assessment in Clinical Trials and Beyond

Yuliya Yasinskaya, M.D. (CDER)

4:15pm – 4:45pm

Special Cardiac Safety Concerns

Shari Targum, M.D. (CDER)

4:45pm – 5:15pm

Drug Induced Liver Injury (DILI)

Mary Ross Southworth, Pharm.D. (CDER)

5:15 pm - 5:30 pm

Discussion/Questions

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

Tuesday
November 8


SESSION 2

FDA & THE REGULATION OF CLINICAL TRIALS


8:30 am - 9:00 am

FDA Perspective on International Studies

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

9:00 am - 9:45 am

Good Clinical Practice (GCP) Key Topics

Bridget Foltz, M.S. (OC)

9:45am – 10:15am

Investigator Responsibilities – Regulation and Clinical Trials

Part I

Cynthia Kleppinger, M.D. (CDER)

10:15 am - 10:30 am

Break


10:30 am - 11:00 am

Investigator Responsibilities – Regulation and Clinical Trials

Part 2

Cynthia Kleppinger, M.D. (CDER)

11:00 am - 11:30 am

Electronic Technologies in Clinical Trials

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

11:30am - 11:45 a.m.

Discussion and 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 am - 12:45 pm

Lunch


SESSION 3

UNDERSTANDING THE INVESTIGATOR BROCHURE: NON-CLINICAL AND PHASE I STUDIES


12:45 pm - 1:15 pm

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

Dorota Matecka, Ph.D. (CDER)

1:15 pm - 1:45 pm

Biosimilar Biological Products

Sue Lim, M.D. (CDER)

1:45 pm - 2:30 pm

Pharmacology/Toxicology in the Investigator Brochure

Brenda Gehrke, Ph.D. (CDER)

2:30 pm - 2:45 pm

Discussions/Questions

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

2:45 - 3:00 pm

Break


SESSION 4

EARLY CLINICAL STUDIES


3:00 pm - 3:30 pm

Clinical Pharmacology 1: Phase 1 Studies and Early Drug Development

Shirley Seo, Ph.D. (CDER)

3:30 pm - 4:00 pm

Clinical Pharmacology 2: Clinical Considerations During

Phase 2 and Phase 3 of Drug Development

Su-Young Choi, (CDER)

4:00 pm - 4:30 pm

Clinical Discussion of Special Populations

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

4:30 pm - 4:45 pm

Discussion/Questions

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

Schedule

Block #4

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12pm - 1pm

How to Build Schedule Blocks

C. Doe

1pm - 2pm

How to Build Text Blocks

R. Doesco

3pm - 4pm

How to Build Cover Blocks

R. Harrison

SESSION C
8:30 am - 9:30 am

Center for Devices and Radiological Health:

How to put Together an Application, Ensuring the Safety of Clinical Trials

Nilsa Loyo-Berrios, Pharm.D.  (CDRH)

Benjamin Eloff, Ph.D.(CDRH)
Veronique Li (CDRH)

9:30 am - 9:45 am

Break


SESSION A
9:45 am - 10:45 am

Center for Drug Evaluation and Research:

Repeat of Session A

Judit Milstein, B.Sc.(CDER)

SESSION B
9:45 am - 10:45 am

Center for Biologics Evaluation and Research:

Repeat of Session B

Donald Fink, Ph.D.  (CBER-CMC)    

Allen K. Wensky, Ph.D. (CBER-Preclinical)        

Rachel Witten, M.D. (CBER-Clinical)  

SESSION C
9:45 am - 10:45 am

Center for Devices and Radiological Health:

Repeat of Session C

Nilsa Loyo-Berrios, Pharm.D.  (CDRH)

Benjamin Eloff, Ph.D.(CDRH)
Veronique Li (CDRH)

Wednesday
November 9


SESSION 5

PUTTING IT ALL TOGETHER: 
IND/IDE APPLICATION AND COMPLIANCE ISSUES

CONCURRENT BREAKOUT SESSION FOR DRUGS, DEVICES, BIOLOGICS


SESSION 1A
8:30 am - 9:30 am

Center for Drug Evaluation and Research: 

How to put Together an IND Submission, Ensuring the Safety of Clinical Trials

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

SESSION 1B
8:30 am - 9:30 am

Center for Biologics Evaluation and Research: 

How to put Together the IND Application: CMC, Preclinical Testing, Clinical Trial Design, Expectations for a First-in-Human Clinical Study, Ensuring the Safety of Clinical Trials

Donald Fink, Ph.D.  (CBER-CMC)    

Allen K. Wensky, Ph.D. (CBER-Preclinical)        

Rachel Witten, M.D. (CBER-Clinical)  

SESSION 1C
8:30 am - 9:30 am

Center for Devices and Radiological Health:

How to put Together an Application, Ensuring the Safety of Clinical Trials

Nilsa Loyo-Berrios, Pharm.D.  (CDRH)

Benjamin Eloff, Ph.D.(CDRH)
Veronique Li (CDRH)

9:30 am - 9:45 am

Break


SESSION 2A
9:45 am - 10:45 am

Center for Drug Evaluation and Research:

Repeat of Session A

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

SESSION 2B
9:45 am - 10:45 am

Center for Biologics Evaluation and Research:

Repeat of Session B

Donald Fink, Ph.D.  (CBER-CMC)    

Allen K. Wensky, Ph.D. (CBER-Preclinical)        

Rachel Witten, M.D. (CBER-Clinical)  

SESSION 2C
9:45 am - 10:45 am

Center for Devices and Radiological Health:

Repeat of Session C

Nilsa Loyo-Berrios, Pharm.D.  (CDRH)

Benjamin Eloff, Ph.D.(CDRH)
Veronique Li (CDRH)

10:45 am - 11:15 am

Clinical Investigator Site Inspections: What to Expect

Patricia Holobaugh, M.S. (CBER)

11:15 am-11:45am

Panel Discussion

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

11:45 am - 12:45 pm

Lunch


SESSION 6

SAFETY OF CLINICAL TRIALS AND SPECIAL POPULATIONS


12:45 pm - 1:30 pm

The Analysis of Investigator Data, Sources of Bias and Error

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

1:30 pm - 2:00 pm

Patient Engagement in Drug Development

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

2:00 pm - 3:00 pm

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 pm - 3:30 pm

Explain Evaluation Process, Wrap up and Adjourn

Leonard Sacks, M.D. (CDER)

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