Your Cart Contents: Number Items: 0
SubTotal: $0.00
e Conferences from CDG...
Every problem is an opportunity.
eConferences are 90-minute slices of current content that identify typical
clinical or regulatory problems and offer serious solutions. In each event
we pick an issue of current concern, describe the issue (regulation,
expectation, obstacle) and then offer strategies, case studies, or solutions
to help you use the problem to get better work result.
A one-hour PowerPoint presentation by an expert in the
field is followed by 30 minutes of Q&A, so you have ample opportunity to get
the personal attention you need.
How it
works: Once your order is
processed, you will receive an email with a receipt for the credit card
transaction from our office. You will also receive an automatically generated
email with an invitation for you to register in the course. Please register, provide your
email address and create a password. Once your invitation is accepted, you
will receive an automatically generated email with the link to join the session.
Here's the question:
In the chart below, are we plotting:
a)Enrollment rate of a trial?
b)Time to completion of a trial?
c)Number of adverse events in a trial?
And your daily predictions of the future will guide you
in making decisions: should you add another investigative site? Throw more
resources at an existing site? Close a site down? Add regulatory staff
because the trial will be done early? If even a simple spreadsheet can use
adaptive designs to predict the future, maybe you should too.
The
storyline: Just returning from a
reconnaissance mission where he discussed the use of Bayesian analysis and
adaptive trial designs with an esteemed faculty of FDA experts, our
speaker’s objective is to tell you how to apply adaptive designs the FDA
way. In this informative and timely follow-up presentation*, he’ll also tell
you if you should apply adaptive designs by using real-life and hypothetical
examples of how they can work for you or against you. Do you have to be a
statistician to attend? Absolutely not! Our speaker is an accomplished
communicator who can make adaptive designs understandable to anyone. *Part 1
of this series “An
Introduction to Bayesian Statistics” laid the groundwork for
understanding the difference between Bayesian vs frequentist statistics. And then he’ll follow with
some practical talk about the impact of adaptive designs on the rest of the
project team: will clinical, regulatory, and other team professionals have
to do anything differently in their jobs?
The playbill (you will receive): Each audience member will
receive:
1. PowerPoint slides.
2. An expert speaker.
3. Chance for QnA.
4. CEUs and certificate of attendance.
The presenter:
Clinical Device Group is proud to present Dr.
Robert P. Thiel. Dr. Thiel has degrees in
physics, clinical counseling and psychometrics.
He is an expert in the analysis of IVD data for
the Medical Device Industry with more than 75
510K and 5 PMA approvals. He has published
papers in the area of free PSA, breast cancer,
ovarian cancer, liver disease and multivariate
analyses as applied to sports (baseball and
basketball). His current interests lie in the
area of bootstrap and permutation test
methodology and the application of these methods
to small sample trials and Bayesian analysis as
applied to diagnostic clinical trials.
Dr. Thiel can be contacted at
rpthiel@thielstatcon.com.
Audience suitability:
[x] Statistical professionals
[x] Non-statisticians interested in the subject
[x] Clinical research professionals who design
clinical trials
[x] Regulatory professionals who report clinical
data
[x] Managers who sign off on clinical trials
[x] Executives who are planning their companies
futures
How it
works: Once your order is
processed, you will receive an email with a receipt for the credit card
transaction from our office. You will also receive an automatically generated
email with an invitation for you to register in the course. Please register, provide your
email address and create a password. Once your invitation is accepted, you
will receive an automatically generated email with the link to join the session.
The e Conference: What's
the
Critical Path Initiative Again?
The Critical Path Initiative is FDA's effort to
stimulate a national effort to modernize the
scientific process of medical device regulatory
review. The Office of Critical Path Programs (OCPP)
is a cross-center structure within FDA that is
working with other public and private
organizations to establish a range of scientific
and regulatory programs to achieve this goal.
According to Janet Woodcock, the private sector
(you) has made massive investments in basic
biomedical research, but regulators (FDA) have
not kept pace with what they call 'regulatory
science'.
'Regulatory science', the FDA's ability to
review a new technology with expertise and
insight, has lagged significantly behind the
private sector. Under resourced and
understaffed, FDA has struggled to keep pace
with evolving technologies. The problem has been
compounded by newly emerging applications like
new molecular technologies, advanced imaging
techniques, nanotechnologies, robotics, and
more.
Last year FDA published a list of 76 examples of
promising and high-priority projects the
initiative will foster. Is your technology among
them?
http://www.fda.gov/oc/initiatives/criticalpath/
What's in it for you?—Hear Nancy Derr from
OCPP tell you
In this e Conference Nancy Derr of the Office of
Critical Path Programs
will
discuss the structure of OCPP, describe existing
projects, discuss collaborative programs inside
and outside of FDA, and outline future projects
and ways you can get involved. She'll provoke
your thinking so you can imagine ways to take
advantage of these initiative for your own new
product development or clinical trial designs.
Will
FDAAA
help?—Hear James G Norman from CDRH answer this
question
The re-authorization of MDFUMA
means a renewal and expansion of user fees. FDA's
James G Norman will discuss
he far-reaching changes made by FDAAA: the new medical device user fee
structure for FY 2008 – FY 2012 including a new
establishment registration fee; new registration
and listing requirements, including electronic
R&L; changes to FDA’s authority concerning
inspection of device establishments by
FDA-accredited third-parties; plans for a
regulation on unique device identification; new
requirements concerning pediatric devices and
devices with potential for pediatric use;
new restrictions of FDA advisory panel member
conflicts of interest; new requirements for
submission of information concerning clinical
trials; and more.
The playbill:
Each audience member will receive:
1. PowerPoint slides.
2. Two expert FDA speakers.
3. Chance for Q&A.
4. CEUs and certificate of attendance.
5. Link to guidance document re "Certifications
to Accompany...Device Submissions."
The
speakers:
Nancy Derr joined the Food and Drug
Administration in 1996. In 2003, she was among
the first staff to be detailed to what was at
the time, the Office of Cross Center Initiatives
(now the Office of Critical Path Programs).
Nancy has been heavily involved in project
management and in the drafting of both the 2004
and the 2006 Critical Path reports, in addition
to other CPI-related policy documents. She is a
member of the Critical Path Steering Committee.
In addition to her duties in the OCPP, Nancy is
involved in managing the development of
regulatory policy. Nancy completed her Masters
Degree at the University of Michigan, Ann Arbor,
in 1977.
James G. Norman is Senior Policy
Analyst at FDA's Center for Devices and
Radiological Health. He has been with the
device program since 1979. He was part of the
FDA team that negotiated and drafted the medical
device provisions of the Food and Drug
Administration Amendments Act of 2007, and is
now working to ensure their smooth
implementation. He holds an M.B.A. from
Virginia Tech and a J.D. from the University of
South Carolina, and is a member of the Virginia
State Bar.
Audience
suitability:
[x] Device Manufacturers
[x] Sponsors
[x] Monitors
[x]
Clinical research professionals who design
clinical trials [x]
Regulatory professionals
[x] CROs
]x] Executives who are planning the future of
their company
How it
works: Once your order is
processed, you will receive an email with a receipt for the credit card
transaction from our office. You will also receive an automatically generated
email with an invitation for you to register in the course. Please register, provide your
email address and create a password. Once your invitation is accepted, you
will receive an automatically generated email with the link to join the session.
Here's the business issue:
Your company makes an in-vitro diagnostic product. How can you, as a
regulatory professional, get the a CLIA waived status from FDA, so that
marketing can offer the product to the maximum number of laboratory
customers?
The
e Conference: Last January FDA
issued a guidance document on "CLIA Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices." In this e Conference, IVD expert Dr. Gail
Radcliffe will interpret the guidance based on her vast experience in the
field, and will supplement her interpretation with feedback from FDA. She
will attempt to predict your questions in white paper fashion; providing
guidance of her own on how to maximize your chances of success.
The presentation will be supplemented case studies to help clarify the
issues.
The playbill (you will receive):
Each audience member will receive:
1. PowerPoint slides.
2. An expert speaker.
3. Copy of the guidance document.
4. Chance for QnA.
5. CEUs and certification of attendance.
The presenter:
Gail E Radcliffe, PhD assists IVD device,
medical device, and biotech companies with
technical, marketing, regulatory, and business
development issues. She brings a unique
viewpoint to the overall process of product
development. Dr. Radcliffe helps emerging
companies assess platform technologies to meet
customer needs, conducts technical due
diligence, and provides regulatory strategy
assistance. She holds several patents and has
worked with clients to obtain funding through
angel investments, venture capital and Small
Business Innovation Research (SBIR) grants. You
can reach her at
gradcliffe@charter.net.
Audience suitability:
[x] Regulatory professionals who make
submissions for IVD devices
[x] Clinical research professionals who's IVD
trial data will be used in submissions
[x] Statistical professionals who's IVD data
analyses will be used in submissions
[x] Managers who sign off on clinical trials
[x] Executives who are planning their companies
futures
Your
Cart Contents: Number
Items: 0
SubTotal: $0.00
