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Current Topics on Medical Device Clinical Research...
These high-level eConferences
are available on CD so you can view the
presentations at your convenience. The CD includes the presentation with
audio, slides, handouts and Q&A for each session. Below
are the topics currently
available:
In this session you will get practical knowledge
and helpful hints in using Central/Eastern Europe to accelerate study
start-up, maximize enrollment and obtain high quality data.
FDA is transforming its operations because the world of medical technology
is getting more complex, the old ways can't keep pace with the new
challenges, and there needs to be a better way to integrate premarket and
post-market processes.--D-B Tillman, Director, ODE/CDRH; 2007.
This eConference
provides participants with an update on FDAAA,
focusing on practical consequences for device companies.
FDA/CDRH/OIVD is committed to educating inventors and manufacturers about
its requirements for approval. Concomitantly, we understand that you are
concerned and eager to learn about their expectations. In this eConference
you will hear directly from FDA Experts about their latest thinking
and get an overview of
Critical Path initiatives at the FDA and explain how they help in shortening
the time to bring innovative medical products to the patient bedside and the
marketplace. Presented by the staff of FDA/CDRH/OIVD
on February 19, 2008.
This presentation will review some of the biggest challenges to implementing
EDC in device trials. It will focus on device trial related issues and offer
solutions or approaches that can be used to address these problems. It will
review device specific inventory issues, EDC edits/queries, subject
management, monitoring and payment challenges, trial management issues and
more. The presentation will also consider the advantages/disadvantages of
CRO hosted trials, self-hosted EDC and third-party hosted EDC.
This eConference is the fourth in a four-part series presented by renowned
experts Dr. Cheryl Hayden and Dr. Robert Thiel.Attendees
of this conference will learn how to preempt common problems that arise in
interactions with the FDA relating to IVD clinical trials. This could save
time and money in both trial conduct and regulatory issues.
This eConference is the third in a four-part series presented by renowned
experts Dr. Cheryl Hayden and Dr. Robert Thiel. This
eConference will help you to determine the best approach to the
statistical analysis of IVD data for FDA approval.
US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007)
mandates the registration of certain device clinical trials. Will you be
ready for the requirements effective on December 26, 2007?The world
doesn’t stop with submitting the clinical study report to FDA. To have
marketing value, to become an accepted part of medical practice, to give
your sales force a reason to walk through the customer's door, your message
needs to get to the clinical community through peer-reviewed
literature. This conference will tell you how to get there.
This eConference was
co-presented by
Ms. Rebecca J. Williams, Assistant Director of
ClinicalTrials.gov annd Dr. Nancy J Stark, President of CDG.
This eConference is the second in a four-part series presented by renowned
experts Dr. Cheryl Hayden and Dr. Robert Thiel. This
eConference will help you design a clinical trial that is effective and
efficient, and help you avoid common errors in IVD trial design. In this
eConference we will discuss issues that affect the validity and utility of
the data collected in an IVD Clinical Trial, and how to avoid pitfalls that
would adversely affect data collection and analysis. We will also discuss
methods of increasing the efficiency of the clinical trial.
Has the FDA required you to establish a Data Monitoring Committee (DMC) for
your upcoming investigational clinical trial? If so, how do you proceed?
What is a DMC and when is it in your best interest to have a DMC oversee
your trial? If you have a DMC, how should it operate and how should your
company interact with the DMC? What should be the qualifications of your DMC
members? How do you respond to DMC recommendations for your ongoing clinical
trial? What type of documentation should be in place for the DMC? If you
have had to ask yourself any of these questions, this eConference will be
helpful to you and your organization. Presented by
Steven C. Schurr, Esq. Mr. Schurr concentrates
his legal practice in health care law. He has acted as chairperson for
several Data Monitoring Committees and has first-hand knowledge in their
organization and operation. Prior to becoming an attorney, Mr. Schurr worked
as a regulatory affairs and clinical affairs professional within the medical
device and pharmaceutical industries. As such, he is highly knowledgeable
about the management and execution of investigational clinical trials. You
can contact Mr. Schurr at
http://www.steveschurr.com
A post-approval study requirement could delay,
or even jeopardize, your approval if you are not fully prepared. In this
eConference you will learn what you need to keep the approval approach to
post-approval study requirements. Even if you are experienced in the FDA
regulation you are facing new procedures and requirements.
Presented by Mr. Jeffrey Shapiro, Esq., on September 19, 2007.
Mr. Shapiro is one of the directors at Hyman, Phelps & McNamara Law
firm in Washington, D.C.
The single most popular,
and FDA-requested quality-of-life assessment, is the SF-36 from Quality
Metrics. But you can't just use an SF-36 questionnaire, it must be validated
for your study population and analyzed correctly. After taking this course
you will be able to determine which, if any, SF-36 is right for you; where
to purchase the forms, manuals, and analysis rules, and how to avoid
frequent pitfalls. Presented by Michelle Secic on
September 18, 2007. Included on the CD is a Excell program for calculating
the scores developed by the speaker. Ms. Secic can be reached at
consult@secicstats.com
Because in
vitro diagnostic trials are structured differently than other device or drug
trials, you need to understand those differences in order to meet regulatory
and marketing needs.This eConference is the
first in a four-part series presented by renowned experts Dr. Cheryl Hayden
and Dr. Robert Thiel. This eConference was presented on
August 29, 2007 by Dr. Cheryl Hayden. Dr. Hayden
has degrees in medical technology, biostatistics, and microbiology. She has
worked for 25 years in the field of clinical research, 8 years in a
consulting capacity. Much of her experience is with in vitro diagnostics.
Product recalls are a reality. Knowing how to handle a
recall can minimize what could be devastating results for your company. The
FDA/CDRH Office of Compliance is committed to educating manufacturers on how
to manage a recall successfully. Experts will review FDA regulations and
discuss FDA procedures related to recalls. Insights on FDA thinking about
the Health Hazard Evaluation process and classification of recalled products
will be shared along with tips on Dos and Donts of the process.
This eConference was presented by the staff of the FDA/CDRH/Office of
Compliance on August 14, 2007.
This eConference will
inform less experienced regulatory affairs
professionals about the overall requirements associated with 510(k)
submissions and to inform or remind the more experienced professionals of
the best ways to deal with difficult applications. Presented
by Ms. Janice
M. Hogan, Esq. and Partner of Hogan & Hartson, LLP. Ms
Jenice is also a frequent lecturer at FDA regulatory
law symposia and conferences on topics related to premarket approval of
medical products, combination products regulation, and product development.
This eConference is the
Fourth in a Four-Part Series on medical device regulations. This Part of the series
is designed to help applicants prepare a premarket approval application (PMA)
that will be complete, that FDA will find easy to review, and that will very
likely lead to an approval decision within a reasonable review time.Presented on July 24, 2007 by Mr. Gerard Prud'home, Esq.,
partner
of Hogan & Hartson, LLP. Mr.
Prud’homme's practice is primarily focused on the regulation of medical
devices and pharmaceuticals, where he represents both small and large
manufacturers with matters before the Food and Drug Administration (FDA).
This eConference will explain the content,
significance, and impact of FDA’s draft guidance document on IVDMIAs. It
will highlight the public responses from laboratories, diagnostic companies,
clinicians, patient advocacy groups, and trade associations. It will present
recent product examples of success, failure and controversy.
Presented by Ms. Christine Bump an
associate with Hyman, Phelps & McNamara, P.C. in Washington, D.C.
Christine’s practice is
focused in the areas of devices, including in vitro diagnostic
devices, and product advertising and promotion.
The Device Directives finished their 5-year
revision process in late March 2007. The amended Directives will soon be
published, requiring European states to update national laws. This sneak
preview will bring you up-to-date on the major changes.Presented by Mr. Roger L. Gray, Director of
European Regulatory Affairs, Donawa Consulting. Based in the United Kingdom
(UK), Roger Gray has worked for over 25 years in the medical device
industry, specializing in European and United States regulatory and quality
management requirements.
This
eConference is designed for regulatory and clinical affairs specialists who
help design clinical trials that will be used to gather data for supporting
FDA marketing applications, and for those specialists who will submit IDEs
to FDA. This session will discuss the preparation
of Investigational Device Exemption Applications (IDEs) that will be: approved
by FDA, provide valid scientific evidence, and support the approval of
510(k)s and PMAs. Presented by Ms. Patsy J. Trisler,
J.D., RAC. and former FDA reviewer, is an independent consultant providing
services related to FDA regulatory requirements and clinical compliance
issues, primarily to the medical device industry.
Any sponsor and any site can be inspected by FDA. True, FDA focuses its
efforts on high-profile significant-risk devices, but their attentions can
spillover to all the clinical trials being conducted by you or your sites,
no matter how non-significant the risk. Once they are looking at you, they
may look at everything you do. The Objective of this
eConference is to teach you, as the sponsor, how to prepare yourself and
your sites for FDA inspections. Presented by Mr. Steven C. Schurr, Esquire.
Mr. Schurr has practiced medical device law for 13 years, was regulatory
affairs professional prior to becoming a lawyer, has himself been inspected
by the FDA as a sponsor, and has assisted clinical trial sponsors in FDA
audits of investigational sites. You can read more about Mr. Schurr at
https://www.steveschurr.com
FDA is facing many challenges in
the review of a growing number of innovative technologies. They may seek
input and advice from one of their 18 scientific advisory panels on any
class of medical device. These panels are made up of independent experts,
scientific and medical professionals. Of their seven functions, your most
direct involvement may be when they provide comment on the adequacy of
safety and effectiveness data you submit.
During a panel meeting, you--as
the product sponsor--present an overview of your safety and efficacy
evidence and respond to questions raised by the panel members. Panel
meetings are held at various times during the year, are open to the public,
and often garner considerable attention from the media.
In this eConference, Dr. Garvey will provide an overview of the FDA advisory
panel process and points to consider in preparing for a panel meeting
developed from FDA documents and panel transcripts, as well as personal
communications with FDA staff and professionals who have helped companies
prepare successfully for panel meetings. Dr.
Patricia L. Garvey, an independent regulatory consultant specializing in
medical devices. Dr. Garvey received a B.A. in psychology and Ph.D. in
biopsychology from the University of California, Santa Barbara. She has
served on the Global Harmonization Task Force (GHTF) Study Group 5 (Clinical
Evidence), represented Edwards on the AdvaMed Technology and Regulation
Board Committee and numerous working groups, and is an Advisory Board Member
for the Master’s Program in Regulatory Science in the University of Southern
California School of Pharmacy. Dr. Garvey has also served on the Centers for
Medicare and Medicaid Services (CMS) Medicare Coverage Advisory Committee (MCAC)
and was a member of the External Science Review Committee for FDA’s Center
for Devices and Radiological Health (CDRH) in 2001.
The world
doesn’t stop with submitting the Clinical Study Report to FDA! To become an
accepted part of medical practice, your message needs to get to the clinical
community through peer-reviewed literature. This conference will provide
important information necessary to publish your study results in
peer-reviewed literature. Presented by Ms. Karen Bannick of Bannick
Consulting, LLC. Ms. Bannick has worked in the medical device industry for
17 years and has developed US and worldwide regulatory strategies for Class
II and III products. Her background is unusually broad, encompassing
biostatistics, clinical research and regulatory affairs. She brings key
insights into developing a comprehensive regulatory strategy—with an eye to
clinical and statistical concerns--for her clients’ products. She has worked
in industry and as a consultant (since 1998) in cardiovascular,
neurological, urological and other devices on 510(k)s, PMAs, PMA Supplements and IDEs. She has
successfully prepared regulatory strategies and brought development teams to
FDA to present them on numerous occasions.
When undertaking to add
clinical sites in Canada, it is important to understand the applicable laws
and expectations that Health Canada has defined to ensure the health and
safety of the Canadian public. This eConference will provide you with an
overview of the requirements, and enable you to communicate effectively with
Canadian investigators, thus ensuring a smooth approval process for your
study application. Presented by Ms. Linda Lindsay on
January 10, 2007.
We may live in an electronic age, but
paper-based case report forms (CRFs) still lie at the heart of most device
trials. Case report forms that don't capture the right content in a
form-filler, friendly format can bring an otherwise well-designed trial to
its knees. Presented by Dr. Nancy Stark on February 27,
2007
A
ClinicalEvaluation, or literature review, is the
assessment and analysis of literature data in order to verify the safety and
performance of a medical device and determine if a clinical trial is
necessary. The
literature review procedure should begin early in the device development
process and can help determine whether or not a clinical trial is necessary.
This eConference is intended to demystify the process for Clinical
Evaluation and clarify in what situations a clinical investigation will be
required. If you are planning to to take your medical device to the
EU marketplace you should have an understanding of this process.
Presented by Ms. Janette Benaddi on December 5, 2006.
Registries are used by companies for internal tracking of
utilization and outcomes. In this eConference you will learn the following:
the purpose and current uses of registry studies; how to plan, implement,
and manage registry studies; the potential ways medical devices are followed
after FDA approval; and why the time period after FDA approval is as
important as obtaining FDA approval itself.
Implementation issues will be discussed by Dr. John
Pandolfino, an experienced investigator and IRB co-chair. Review issues will
be discussed by Dr. Elise Berliner, a member of AHRQ who provides scientific
input to CMS. The eConference will be moderated by Anne Marie Murphy, who's
legal practice deals with the day-to-day issues of medical devices.
Presented by Dr. John Pandolfino and Dr. Elise Berliner on November 21,
2006.
FDA deliberately focuses on predominant device
companies to use them as examples for the rest of us. In this eConference we
will: 1) review the rules for reporting adverse events, 2) review a sample
SOP, 3)examine the two-form strategy for safety checks and collecting
adverse event collection, 4) benchmark against the industry's Most Common
Practice, 5) examine what FDA has said about adverse event reporting to top
tier device companies, and 6) discuss actual examples of adverse events.
Presented by Dr. Nancy J. Stark on November 10, 2006.
Whether you are a
sponsor, CRO, investigational site, or other center, you have valuable
intellectual property, trade secrets, and methods of doing business that
need protection from misuse or misappropriation. For example, sponsors, CROs,
sites and consultants may own trademarks, copyrights, patents and
proprietary information such as customer/vendor lists and pricing
information. So everyone has intellectual property they need to protect.
This eConference will To
address the various types of intellectual
property, the risks associated with utilizing them in research, and legal
methods to protect them.
Presented by Mr. Steven C. Schurr, Esquire as
presenter, has practiced medical contract law for 12 years and was a
clinical monitor and regulatory affairs professional in a prior life. You
can read more about Mr. Schurr at
https://www.steveschurr.com
The new
revision of the EU Medical Device Directive contains important new
requirements for clinical data needed for CE marking and post-market
vigilance. If you are developing a technical dossier, planning a clinical
study in Europe, or managing clinical surveillance activities, this
conference will allow you to tailor your strategy to the changing regulatory
environment. Presented
by Dr. Maria Donawa and Dr. Monica Tocchi on October 12, 2006. Dr. Maria
Donawa has nearly twenty-five years of regulatory experience. From 1980 to
1986, she worked with the United States (US) Food and Drug Administration in
the area of medical device regulation. In 1986, after moving to Rome, Italy,
she founded two consulting companies, which have now become Donawa
Consulting with offices in Italy, Switzerland, and the US. The firm provides
medical device US and European regulatory assistance; US quality system
auditing services; and, European clinical research study management, sponsor
training, monitoring, and data management. Dr. Monica Tocchi is a physician
with a specialization in cardiology and a Ph.D. in Cardiovascular
Pathophysiology. She has over ten years experience in designing and managing
clinical studies. In addition, Dr. Tocchi has been a medical consultant for
leading pharmaceutical and medical device companies and co-authored landmark
clinical study publications related to the use of cardiovascular drugs, in
vitro diagnostic devices, cardiac pacing devices, cardiac stents, and
cardiac imaging technologies.
The Global
Harmonization Task Force (GHTF) is a voluntary international organization
comprising regulatory authorities and representatives of industry intent on
developing statements (i.e., documents) and cross-checks for bringing
medical devices to global market. This eConferece will discuss the
existing documents as well as directions for the future. Presented by Dr.
Ronda Balham, former official of the U.S. FDA Center for Devices and
Radiological Health (CDRH) and a former Executive Secretariat for the Global
Harmonization Task Force (GHTF). She is Director, Global Regulatory Affairs
for Donawa Consulting, a firm with locations in Europe (Italy and
Switzerland) and the U.S. providing regulatory affairs, clinical research,
quality management system, and European Authorized Representative services
to medical technology companies.
What good is it if your device is a research success and a marketing failure? All
the hard work, innovation, and intensive development are for naught if the
patient cannot afford your product. In this half-day conference, we will
explore the difficulties and key pathways to gaining CMS reimbursement for
new medical technologies. This eConference will help you understand
the system and learn how to work within it. Sponsored by
CDG and FDLI this event was presented by a panel of experts who
covered Reimbursement for Medical Technology Overview of
CMS coverage Coding Systems, Evidence-Based Technology Assessments, The
CMS Coverage Process & Private Payers.
As the former Vice
Chairman for the European Notified Bodies, Poul Schmidt-Andersen brings a
unique perspective to their expectations. In this presentation he will
discuss what companies do badly and offer assistance in doing it well.This
session will cover the European Regulatory System for Medical Devices
and the most resent proposed updates on the Medical Device Directive and how
they affect your relationship with Notified Bodies; the
importance of defining the intended use for the product; which, in turn,
controls the classification and available conformity assessment procedure;
how to identify the criteria for selecting the right Notified Body,
How to establish an overall plan for the cooperation between the
manufacturer and the Notified Body; how to
organize documentation for compliance of medical devices to be submitted to
the Notified Body; and how to document quality
system, plan and carrying out Notified Body audits of the systems.
Presented by Mr. Poul Schmidt-Andersen
founder of the DGM - the Danish Medical Devices Certification
Organization and Notified Body for the IVDD and MDD Directives. As Managing
Director of DGM he was responsible for its development until July 2001 when
he resigned to start his own consultancy firm, Copenhagen Medical Devices
Consulting aps. Until leaving DGM he acted as Vice-Chairman for the
"Notified Bodies Medical Devices Group" which was designed to promote
co-operation between Notified Bodies, medical device manufacturers and the
EU-Commission.
An upcoming regulation in the EU will affect the marketing of
human tissue products and these requirements are different from the US
philosophy.
The eConferece will
address current framework and regulations in the EU and US regarding human
and animal tissue medical products and will predict what new changes are on
the horizon.
You will also learn about the new ISO requirements regarding
animal tissue used in medical devices. Presented by Ms. eliane Schutte,
MSc, Director Regulatory
Affairs for IsoTis OrthoBiologics, a public company based in the US, The
Netherlands and Switzerland. She maintains contacts with regulators such as
FDA, notified bodies, local regulatory authorities. Ms. Schutte also owns a
consulting firm called Signifix, whose focus is regulatory support to
companies in the field of tissue engineering, combination medical products
and medical devices.
Japan has a new medical device GCP regulation and it is different from the
ISO or US standards. Revised in 2005, the regulation was followed by several
supplemental notifications.
This eConferece consists of a comprehensive overview of the present state
of affairs.
Presented by Ms. Nobuko Matsunaga, Chief
Regulatory Officer of Japan MDC,
LLC, a Japanese regulatory and marketing consulting firm specializing in
medical devices. Ms. Matsunaga is experienced in working for foreign medical
device companies in the regulatory field. Ms. Matsunaga’s career in
regulatory affairs started when she joined Nippon Eurotech, a medical device
distributor in Japan. At Nippon Eurotech, she was assigned to technical
development and worked as a regulatory assistant. She then joined Edap
Technomed Inc., a Japanese subsidiary of a French medical device company as
a regulatory officer. With more than 10 years regulatory work experience,
she became an independent consultant and established Japan MDC together with
Kunihiko Mitsuda.
Dealing with advanced
issues, this eConference will cover the process of contract
negotiation, critical contractual terms and their practical meaning, how to
recognize major contractual issues before they become serious, how to set
standards of performance within contracts, how to assure you own the data.
It will also discuss which form of payment is better for you, grants or
performance payments, and how to avoid civil and criminal liability.
You will receive the Schurr Template for Investigator Agreements.
Presented by Mr. Steven C. Schurr,
Esquire as presenter, has practiced medical contract law for 12 years and
was a clinical monitor and regulatory affairs professional in a prior life.
You can read more about Mr. Schurr at
https://www.steveschurr.com/.
This 3-hour eConferece will present an opportunity for you
to learn the latest thinking from OIVD on best practices for IVD
development. The staff of the Office of In Vitro Diagnostics will discuss
the study, quality, and pre-IDE expectations for the commercialization of
new in vitro diagnostic tests—
In Vitro Diagnostic (IVD) Device Studies—Sally Hojvat PhD, Overview of
the Quality System regulation—Tonya
Wilbon B.S., M.S. (ASCP) and Pre-IDEs—Sousan
Altaie PhD. Presented on June 13, 2006.
We will review the basics of genotoxicity testing as
described in ISO 10993-3: Biological evaluation of medical devices – Tests
for genotoxicity, carcinogenicity and reproductive toxicity. We'll explain
each test and the significance of its results. The challenge to global
harmonization in the European Union, United States and Japan will be
discussed. Presented by Dr. Molly Ghosh, Associate Director of Toxicology at
NAMSA, holds a Ph.D. in Pharmacology and Toxicology. She is an active member
of ISO's TC194 to establish the international genotoxicity testing standard
for medical devices.
To order go to
https://www.clinicaldevice.com/OrderForm.htm
Center for Devices
recently endorsed the draft guidance “Patient-Reported Outcome Measures: Use
in Medical Product Development to Support Labeling Claims.
Learn when
Patient Diaries should be used to capture primary endpoints, how to develop
and validate them, and the special statistical considerations that apply to
their data.
The
CD includes the Secic Binder of Patient Diaries – a
compilation of hands-on examples of what FDA wants to see.
Presented by Michelle Secic on April 05, 2005.
Mrs. Secic is the President of Secic Statistical Consulting, Inc., where she
works on a variety of medical research projects. She aids companies around
the world with the statistical aspects of their research, from small
projects to large clinical trials involving drugs or medical devices. She
received her Master of Science degree in Applied Statistics in 1990. She
worked at the Cleveland Clinic Foundation from 1990 through 2001, when she
left to continue expansion of her own consulting company. She authored a
book in 1997 titled “How To Report Statistics in Medicine”, which was
published by the American College of Physicians. The Book was also
translated into Chinese and published in China in 2002.
Last November, FDA presented an eConference through CDG in which they
proposed that device manufacturers develop quality systems to maintain
control of their clinical study activities. They proposed using the already
required Quality System Requirements found in 21 CFR 820. Furthermore, the
next version of ISO 14155 will require all clinical studies be conducted
under a sponsor quality system. You can find out what such a quality system
might look like if you take this eConference.
Presented by Dr. Nancy J. Stark on May 2, 2006.
This eConference will describe the IDE content requirements; FDA
interactions prior to, and during the IDE submission and review process; and
convey helpful hints on how to proactively avoid unnecessary delays in FDA’s
approval to initiate the IDE clinical trial. The CD
includes the Trisler 12-Part IDE
Template plus checklist for easier development of your IDE. Presented by
Ms. Patsy J. Trisler, J.D., RAC. Ms. Trisler is an independent consultant
providing strategic consulting, guidance and training to medical device
companies on FDA regulatory and clinical compliance requirements. Her
expertise encompasses regulatory strategic planning for a wide variety of
product categories at all development phases; determination of non-clinical
and clinical test requirements; preparation of FDA submissions; assistance
with FDA meetings; extensive consulting with clients on regulatory
