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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.

Upcoming eConferences
The Risks and Benefits of Adaptive Designs
FDA on the Critical Path Initiative
Aiming for CLIA Waiver

 

The Risks and Benefits of Adaptive Designs

Quantity:

 

Schedule:
May 21, 2008 at 11:00 am Central

Fee: $420 per computer/phone connection

Agenda:
Lecture - 60 minutes
Q&A - 30 minutes

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

 

 

FDA on the Critical Path Initiatives

Quantity:

Schedule:
May 29, 2008 at 11:00 am Central

Fee: $550 per computer/phone connection

Agenda:
Lecture - 60 minutes
Q&A - 30 minutes

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

 

Aiming for CLIA Waiver

Quantity:

Schedule:
June 11, 2008 at 11:00 am Central

Fee: $421 per computer/phone connection

Agenda:
Lecture - 60 minutes
Q&A - 30 minutes

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


 

 

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