Global
CompliancePanel
Knowledge, a Way Forward
2-day In-person Seminar:
Designing and Monitoring Approvable
Medical Device (cardiovascular) Protocols
Price
Baltimore, MD
Price:
February 4th & 5th 2016
9:00 AM to 6:00 PM
Charlene M. Jett
President- 3R's Management Consulting
and Therapeutics Inc
Charlene M. Jett is currently President of 3R's
Management Consulting and Therapeutics, Inc. She has provided clinical
research, regulatory and quality services to the pharmaceutical, medical
device, diagnostic and chemical industries. This has encompassed over 30
different companies in 20 years. Charlene was employed by G.D. Searle
and Abbott Laboratories for about 17 years. She achieved the positions of
Sr. Research Biochemist , Sr. Clinical Research Associate (CRA) and
Project Manager. She has worked in the specialties of cardiology,
anesthesiology and surgery, anti-infective, rheumatology and cancer, plus
others. She has written numerous protocols, consents, monitored clinical
trials, written literature reviews, and medical summaries. She has created
several publications and presentations. She has also taught graduate
statistics and ethics; was a caregiver for her mother. Charlene obtained her
BS in Physiology(Pre-Med) from the University of Illinois, MS in Biology
from Northeastern Illinois University and another MS from Lake Forest
Graduate School of Management. She currently is a member of Sigma Xi
and the American Chemical Society, where she enjoys their many
webinars.
Why should you attend:
This seminar should be attended to ensure the proper compliance and
development of traditional and new cardiovascular medical devices.
Failure to attend could result in poorly managed clinical trials, wasted
nancial resources and liability based law suits. The development of welldesigned clinical trials and rigorous monitoring is required. From the
literature review to the last appendix, a protocol is THE tool required to be
approved by IRBs, FDA and the sponsor/developer of the device.
$1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Global
CompliancePanel
2-day In-person Seminar:
Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols
Overview
Who will benet:
Construction of an approvable clinical trial protocol
Scientists
Nurses
Pharmacists
Clinical Research Associates (CRAs)
Medical Monitors
Medical Directors
Statisticians
Project Managers
Quality
Regulatory
Manufacturing and Labeling
Administration
requires, excellent scientic writing and organization
skills. Also paramount is gathering necessary
information to manage the statistical analysis and data
management of the study. This usually starts with a
literature review, establishing key efcacy and safety
parameters and determining proper sample size.
Sample size calculations are a very important aspect of
clinical trials, as are the consent and data collection
forms, therefore the statistics and data management
departments must be included for their input into the
protocol and timelines.
An initial input, draft review and nal protocol review
meeting of all concerned departments should also
include labeling, manufacturing, quality, regulatory,
project management. It is also a good idea to get
individual investigators input into the protocol design
and data collection forms. At this point they can also
create a draft budget for their participation. Once all
input has been gathered the sponsor approval process
can proceed.Once the sponsor has approved the
protocol, all relevant IRBs must approve the protocol.
AGENDA:
Day One
Day Two
Lecture 1:
Lecture 1:
Medical devices and purpose of testing and
Data based management, queries and errors
experimentation
Regulations and project management
Organizations: people and processes
Statistical analysis and reports
Medical Summaries
Lecture 2:
Lecture 2:
Designing a protocol, meetings and writing
Overviews
Consents, statistics, data management
Combined Summaries
CBP and FDA computer programs
Questions
Lecture 3:
Questions
Lecture 3:
Training by sponsor of staff
Technology
Training of sites and staff
Security
Tracking
Bottlenecks
Lecture 4:
Monitoring trips and reports
Device safety reports and adverse events
tracking
Questions
Lecture 4:
Expectations
Legal
Questions
2-day In-person Seminar:
Global
CompliancePanel
Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols
What You will get
Group Participation
10%
2 Attendees to get offer
20%
3 to 6 Attendees to get offer
25%
30%
Learning Objectives
Participation certicates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
7 to 10 Attendees to get offer
10+ Attendees to get offer
Payment Option
based trainings.
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
Special price on future consulting or expertise
services.
Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
GlobalCompliancePanel.
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
Special price on future seminars by
Seminar Kit includes presentation handout,
our toll free +1-800-447-9407 for the invoice and
ID card, brochure, trainings catalog, notepad
you may fax the PO to 302 288 6884
and pen.
Wire Transfer: Please drop an email to
[email protected] or call our
toll free +1-800-447-9407 for the wire transfer
Networking with industry's top notch professionals
information
Contact Information: Event Coordinator
161 Mission Falls Lane, Suite 216,
Kindly get in touch with us for any help or
information.
Fremont, CA 94539, USA
Look forward to meeting you at the seminar
NetZealous LLC, DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email:
[email protected]www.globalcompliancepanel.com
GlobalCompliancePanel
