Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Archive
Library
Clinical
Research: To
GLP or Not to GLP: Perspectives from the contracting
Lab |
|
| Speaker: |
Mike
Brooker of Battelle Labs |
| Date
of Briefing: |
June
29th, 2006 |
| Approximate
length: |
One
hour |
| Description: |
During
this CD, the presenter analyzes the value of GLP
by focusing on, deciding to have protocol, determing
how much QA involvement is needed, perfroming "repeat
work" until the method works, overcoing lack
of appropriate documents, working with formalized
approval SOPs and much more. |
| Price: |
$325
CD |
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|
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to the
Order Form |
Archive
Library
Clinical
Research: How to Prepare for FDA Clinical
Research Audits |
|
| Speaker: |
Dr.
Jerri Perkins, Perkins &Perkins |
| Date
of Briefing: |
February
7,2006 |
| Approximate
length: |
One
hour |
| Description: |
Attend
this briefing and hear directly from an experienced
phd how to de-mystify the process of an FDA
inspection, the importance of pre-FDA audits,
and how to respond to the FDA after an audit.
|
| Price: |
$325
CD |
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to the
Order Form |
|
|
Archive
Library
Clinical
Research: How
to Determine if Your Investigator-Initiated
Research Requires an IND/IDE |
|
| Speaker: |
Harvey
M. Arbit, PharmD, MBA, RAC, Director,
IND/IDE Assistance Program, Academic Health Center, University of
Minnesota |
| Date
of Briefing: |
November
22, 2005 |
| Approximate
length: |
One
hour |
| Description: |
During
this CD, the presenter offers several examples
of studies that have gone through the
assessment process and the outcome regarding
IND and IDE applicability. |
| Price: |
$250
CD |
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|
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to the
Order Form |
Archive
Library
Clinical
Research: Clinical Trial Size and Adverse
Event Reporting |
|
| Speaker: |
Sol
Weiss, Shareholder of Anapol Schwartz |
| Date
of Briefing: |
February
24, 2005 |
| Approximate
length: |
One
hour |
| Description: |
Attend
this briefing and hear directly from an experienced
trial attorney on clinical trial research. Learn
the affects of clincal trial size on adverse event
reporting and understand the steps to avoid legal
action. |
| Price: |
$250
CD |
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Go
to the
Order Form |
|
|
|
|
Archive
Library
Clinical
Research: ClinicalTrials.gov and FDAMA Section
113-Study Disclosure |
|
| Speaker: |
Theresa
Tiogo, Director, Office of Special Health
Issues, FDA and Alexa McCray, Ph.D., Director,
ClinicalTrials.gov, National Library of Health,
NIH |
| Date
of Briefing: |
October
12, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
Listen
to experts from FDA and NIH explain how to
post study data in compliance with Sec. 113
of the FDAMA. If you or your clients are responsible
for FDAMA compliance, you must hear this important
and timely audiobriefing. |
| Price: |
$195
CD |
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|
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to the
Order Form |
Archive
Library
Clinical
Research: How to Prepare for FDA AuditsTrials |
|
| Speaker: |
Jerri
Perkins, MD, Perkins & Perkins |
| Date
of Briefing: |
May
20, 2003 |
| Approximate
length: |
One
hour |
|
Description: |
FDA
inspections typically are dreaded and often feared. This interactive
session -- designed for companies, site personnel, monitors,
and auditors - is presented by a former FDA medical officer
who has conducted numerous audits of clinical studies. The FDA
consultant reveals what techniques should be employed BEFORE
an FDA site inspection and what to expect DURING an actual FDA
audit. |
| Price: |
$150
CD |
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Go
to the
Order Form |
|
|
Page
last updated
October 16, 2006
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Source © Copyright 2006
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