Clinical Investigator Training Course: 2017

Target Audience

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

Additional Training

Looking for more training? The University of Maryland online MS in regulatory science degree program provides graduates with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifecycles. Designed for working professionals, the degree program is exclusively online and is part-time over two years. More information is available online.

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) Audio	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) Audio	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 A udio	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 Audio	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 Audio	Hisani Madison, Ph.D., M.P.H. (CDRH)
1:30 - 2:00 p.m.	Issues in Clinical Trial Design for Rare Diseases Audio	Jonathan Goldsmith, M.D. (CDER)
2:00 - 2:45 p.m.	Informed Consent and Ethical Considerations in Clinical Trials Audio	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 Audio	Sumathi Nambiar, M.D. (CDER)
3:45 - 4:15 p.m.	Safety Assessment in Clinical Trials and Beyond Audio	Yuliya Yasinskaya, M.D. (CDER)
4:15 - 4:45 p.m.	Special Cardiac Safety Concerns Audio	Shari Targum, M.D. (CDER)
4:45 - 5:15 p.m.	Drug Induced Liver Injury (DILI) Audio	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 Audio	Kassa Ayalew, M.D., M.P.H. (CDER)
9:00 - 9:45 a.m.	Good Clinical Practice (GCP) Key Topics Audio	Bridget Foltz, M.S. (OC)
9:45 - 10:15 a.m.	Investigator Responsibilities – Regulation and Clinical Trials (Part I) Audio	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) Audio	Cynthia Kleppinger, M.D. (CDER)
11:00 - 11:30 a.m.	Electronic Technologies in Clinical Trials (Sacks) Audio 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 Audio	Dorota Matecka, Ph.D. (CDER)
1:15 - 1:45 p.m.	Biosimilar Biological Products Audio	Sue Lim, M.D. (CDER)
1:45 - 2:30 p.m.	Pharmacology/Toxicology in the Investigator Brochure Audio	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 Audio	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 Audio	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 How to put Together the IND Application (CBER): CMC, Preclinical Testing, and Clinical Trial Design Expectations for a First-in-Human Clinical Investigation (Fink) How to put Together the IND Application (CBER): CMC, Preclinical Testing, and Clinical Trial Design Expectations for a First-in-Human Clinical Investigation (Wensky) How to put Together the IND Application (CBER): CMC, Preclinical Testing, and Clinical Trial Design Expectations for a First-in-Human Clinical Investigation (Witten)	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 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, 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 Audio	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 Audio	Susan Ellenberg, Ph.D. (University of Pennsylvania)
1:30 - 2:00 p.m.	Patient Engagement in Drug Development Audio	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 Audio	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)

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Target Audience

Additional Training

Monday, November 7th

Session 1: The Clinical Trial Protocol

Tuesday, November 8th

Session 2: FDA and the Regulation of Clinical Trials

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

Session 4: Early Clinical Studies Session

Wednesday, November 9th

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

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Session 6: Safety of Clinical Trials and Special Populations