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Research Design (-14) This workshop will provide participants with: 1. An overview of pre-clinical device evaluation requirements (laboratory and animal studies) for IDE submission. 2. A discussion of IRB regulations for human subject research and guidelines for submitting IRB protocols. 3. An overview of good clinical investigations includ- ing study design (pilot studies, variables, controls, sample size, blinding and bias), study conduct, and analysis. R. Shlansky-Goldberg, MD- P. Cole, MD, PhD Manager, Office of Device Evaluation, FDA (TEA) Room Design and Equipment Purchase (-15) Workshop attendants will learn: 1. How to evaluate and complete various angiographic systems. 2. How to evaluate the need for optional features in angiographic systems. 3. What to consider in the design of an angiography suite. D. Trost, MD- Searching for a Job (-16) Participants attending this workshop will gain an under- standing of: 1. The differences between private and academic practices and how these impact on an interventional practice. 2. An outline of the important steps in the job search and interview process. 3. The strategies to employ in defining a job descrip- tion for an interventional radiologist. J. Van Hove, MD* F. Taylor, MD 368 Workshops Spiral CT (-17) The objectives of this workshop are: 1. To provide a background on the utility and role of spiral CT angiography from an interventionalist's perspective. Do I need it? How do I get full use out of its capabilities? 2. To discuss and review the merits and weaknesses of spiral CT relative to conventional angiography. What can it do, what can't it do? 3. To provide a forum for determining whether acquisi- tion of a spiral scanner will have benefit for your practice - from routine tomographic scanning to planning complex interventional procedures. Why should my practice spend over a half-million dollars for the scanner? Is it worth it? C. Semba, MD' S. Kee, MD Introductory Thrombolysis (-18;) Thrombolysis (-18) At the conclusion of the workshop session, the partici- pant will: 1. Understand the key biochemical pathways in throm- bolysis and the pharmacology of thrombolytic agents. 2. Know the clinical indications and contraindications for thrombolytic therapy in the arterial and venous systems. 3. Be familiar with the various delivery systems and dosage regimens used in thrombolysis. 4. Be able to evaluate the initial and long-term results of thrombolytic therapy. 5. Appreciate patient management issues including potential complications. Faculty-Introductory and Advanced 1bromboZysis D. Zuckerman, MD' M. Meyerovitz, MD J. Benenati, MD K. Openshaw, MD J. Cynamon, MD A. Roberts, MD T. Egglin, MD D. Siegel, MD C. Jarmolowski, MD K. SUllivan, MD S. Kaufman, MD D. Trost, MD T. McNamara, MD

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Research Design (-14)This workshop will provide participants with:

1. An overview of pre-clinical device evaluation

requirements (laboratory and animal studies) for IDE

submission.

2. A discussion of IRB regulations for human subject

research and guidelines for submitting IRB protocols.

3. An overview of good clinical investigations includ­

ing study design (pilot studies, variables, controls,

sample size, blinding and bias), study conduct, and

analysis.

R. Shlansky-Goldberg, MD­

P. Cole, MD, PhD

Manager, Office of Device Evaluation, FDA (TEA)

Room Design and Equipment Purchase (-15)Workshop attendants will learn:

1. How to evaluate and complete various angiographic

systems.

2. How to evaluate the need for optional features in

angiographic systems.

3. What to consider in the design of an angiography

suite.

D. Trost, MD-

Searching for aJob (-16)Participants attending this workshop will gain an under­

standing of:

1. The differences between private and academic

practices and how these impact on an interventional

practice.

2. An outline of the important steps in the job search

and interview process.

3. The strategies to employ in defining a job descrip­

tion for an interventional radiologist.

J. Van Hove, MD*

F. Taylor, MD

368

Workshops

Spiral CT (-17)The objectives of this workshop are:

1. To provide a background on the utility and role of

spiral CT angiography from an interventionalist's

perspective. Do I need it? How do I get full use out

of its capabilities?

2. To discuss and review the merits and weaknesses of

spiral CT relative to conventional angiography. What

can it do, what can't it do?

3. To provide a forum for determining whether acquisi­

tion of a spiral scanner will have benefit for your

practice - from routine tomographic scanning to

planning complex interventional procedures. Why

should my practice spend over a half-million dollars

for the scanner? Is it worth it?

C. Semba, MD'

S. Kee, MD

Introductory Thrombolysis (-18;)

Thrombolysis (-18)At the conclusion of the workshop session, the partici­

pant will:

1. Understand the key biochemical pathways in throm­

bolysis and the pharmacology of thrombolytic agents.

2. Know the clinical indications and contraindications

for thrombolytic therapy in the arterial and venous

systems.

3. Be familiar with the various delivery systems and

dosage regimens used in thrombolysis.

4. Be able to evaluate the initial and long-term results

of thrombolytic therapy.

5. Appreciate patient management issues including

potential complications.

Faculty -Introductory and Advanced 1bromboZysis

D. Zuckerman, MD' M. Meyerovitz, MD

J. Benenati, MD K. Openshaw, MD

J. Cynamon, MD A. Roberts, MD

T. Egglin, MD D. Siegel, MD

C. Jarmolowski, MD K. SUllivan, MD

S. Kaufman, MD D. Trost, MD

T. McNamara, MD