We got the message, you're busy people and can't
always be available for an e Conference at 11:00 am Central time. And you're
under pressure; once you realize you need to know something you want access
to the information right away. "Why can't someone have a library of
professional training that we can access 24/7?"
We do, and you can. Our high-level e Conferences
areall available on CD
and becoming available OnDemand so you can view the
presentations on your schedule, when you need it.
Both formats include a
recording of the live presentation with
audio, slides, handouts and Q&A for each session.
In
this e-conference you will learn how to implement Part 11 requirements in
an MS Access database. This presentation will provide the instructions,
materials and documentation to ensure full compliance with 21 CFR Part 11
for Access databases.Presented by
Mr. Tayson M. Mew, President of Ofni Systems, on February 18, 2009.
What validation means in the context of a spreadsheet isn’t well defined,
and which spreadsheets need to be validated depends on what you’re doing
with them. Part 11 and the FDA’s actions with that rule have caused a lot
of doubt, fear, and uncertainty. In this e-conference you will learn which
Excel spreadsheets must be validated to Part 11 and how to do so when you
need to. Presented by Derek Wimmer from
Wimmer Clinical Consulting on
February 4, 2009.
In this informative and useful event, Ms. Nobuko Matsunaga will present
the most recent news on Japan’s GCP
revisions. She will cover: the requirements to conduct clinical trials in
Japan in terms of a GCP audit with documents, facts, and examples, and
situations with case studies in which clinical data collected in the US
can be used for submission in Japan.
Presented by Ms. Nobuko Matsunaga, Chief
Regulatory Officer of Japan MDC on
January 21, 2009.
In this e-conference you will learn how to
set up a modern, Part 11 compliant, data management center in a small
company.Based
on experiences, successes, and failures they have seen across dozens of
trials, our presenters, Derek and Patricia Wimmer, will discuss
step-by-step strategies on how to develop and implement a clinical data
management program. Presented by Derek and Patricia
Wimmer from Wimmer Clinical Consulting on January 15, 2009.
In this timely and solution packed
e-conference, you will learn about the new and evolving requirements. You
will learn specifically how to avoid some of the new barriers to
publishing. Our presenter will provide an overview of the current and
historical issues regarding clinical trial publication. Presented on December
17, 2008 by Ms. Karen Banick from
Bannick
Consulting LLC.
The biocompatibility testing decisions you make will affect the ease of
your submission approval process and help protect you from the device
recalls your competitors may be undergoing. Following the risk management
and biocompatibility guidance contained in ISO 14971 and ISO 10993 may not
be enough, you need to think proactively to what questions or issues may
lie ahead. In this e-conference a teamwork approach --
from the individual developer to authoritative third-party review -- will
be emphasized to help you to "do the right test right" and enable you to
defend your product safety decisions. Current FDA Class I recalls will be
used as examples. Presented on December 3, 2008 by
Dr.
Daniel McLain, MS/PhD, of
Walker Downey and Associates
This presentation provides a framework for determining when it may be
useful to obtain a code, how to go about getting code(s), and how to affect
reimbursement when a new code is not necessary. Presented on
November 19, 2008 by Mary Ann Clark of the
Burgess Group.
1Can Ninsho get me to
market faster?
In Japan a new PAL (regulatory affairs law) was implemented and some
submission categories were established. Ninsho is one of these submission
categories. It is applied for me-too medical devices and offers a faster
route to market. From this
e-Conference you will get a clear image of the faster route of submission
in Japan, and it will help you determine submission strategies for me-too
devices.
Presented by Ms. Nobuko Matsunaga, Chief
Regulatory Officer of Japan MDC on
November 12, 2008.
Esteemed
trainer Janette Benaddi
of Medvance Ltdwill
discuss where to find the rules for reporting adverse events and effects
in Europe, how they differ from one country to another, and how to follow
them. She will address the issues that make European AE reporting so
difficult for Americans. She will also give us valuable insight into what
European sponsors really do. Presented on November 5, 2008.
ISO/DIS
14155 Clinical investigation of medical devices for human subjects--good
clinical practices
(2008) is a total rewrite of the 2003 Parts 1 and 2 versions of this
standard. Five years in the making, harmonized with ICH/GCPs and intended
to be the global standard for medical device clinical trials; the working
group proudly amended the title to include the phrase "good clinical
practices". This standard tells the newcomer how to do a clinical trial,
step-by-step, record-by-record, document-by-document. This standard is
meant to be a teaching document, and it succeeds. Dr. Stark focuses on
what's new in the standard, what's different from the 2003 version, and
describes what the standard expects in terms of quality, quality, quality.
The e-conference was presented Nancy J Stark, PhD
of Clinical Device Group on October
29, 2008.
ISO 13485 is the medical device version of the famous ISO 9000. Titled
"Medical Devices--Quality Management Systems", the standard makes it clear that
quality starts at the top. In this e-conference, quality systems expert Rod
Ruston teams up with clinical research expert Nancy J Stark to address a very
unusual question, can ISO 13485 be applied to clinical trials? The answer, of
course, is yes! Mr. Ruston begins with a thorough overview of the standard,
emphasizing the need for quality systems to be company-wide; then Dr. Stark
follows with specific recommendations about how the company can craft an
application to a clinical research department. The recommendations can be
applied to any department, by reminding us, for example, that our customer is
the next department in the workflow, the person who uses our work product. The
e-conference was presented by Rod Rustion of
Priory Analysts and Nancy J
Stark of Clinical Device Group on
October 8, 2008.
The 510(k) remains the most common route to market for
medical devices in the United States, more than 5000 are cleared by FDA every year. Yet
submissions frequently contain common mistakes that could be easily addressed
beforehand, if only the writer had better insight into FDA's expectations. In
this event the speaker reviews application of the Mohan Memorandum (#K86-3) to
determine substantial equivalence to a predicate device and discusses what
kinds of devices can be used as predicates. The speaker discusses how to choose
the right claim to win a substantial equivalence ruling, and strategies for
introducing new features to an existing medical device. This extremely valuable
e-conference was presented by Janice
Hogan, Esq and Yarmela Pavlovic,
Esq on September 24, 2008.
Registry studies provide a flexible way to collect post-market
reimbursement data, demonstrate product effectiveness, explore new hypotheses,
and provide valuable information not available elsewhere that can be used to
support buying decisions. So how do you set it up?
Dr. Gail Radcliffe will combine
examples and industry feedback to
give a presentation that addresses
how to use registries to bring
products to market and introduce
treatments to physicians. She will
address why you might want to open
a registry, study design, IRB
issues, consent, how much to pay,
use for off label submission to
FDA, existing data sources, and
other common concerns.
Presented by Dr. Gail Radcliffe on September 10, 2008.
We know that 99% of IDEs are reviewed
within 30 'FDA review' days, but how many are approved?
Ultimately, less than 60% in 2007 and the review time was often 90 days or
more. And was the IDE approved or withdrawn? The most
common questions had to do with study design and statistical design, followed
by issues with the consent form.
Benchmark your
practices with those of an experienced regulatory professional and stay ahead
of
the issues before they become questions from FDA.Presented
by Ms. Janice Hogan on August 20, 2008.
How do you know if you
need a PMA or a 510K,
which kind of 510k (there are four), a class II device or a Class III
device, and the business advantages and disadvantages of each choice. If
you didn't think you had a choice, well it's all in the claims. What you
say about about your technology will often dictate the regulatory strategy
and submission requirements. Hear how
Ms. Janice Hogan
discussed these issues on July
30, 2008.
Your company is doing a clinical trial and the endpoints dependon clinical or technology laboratory data. You need to assure
FDA that you have validated data from the
clinical lab, mass spec lab, dialysis clinic lab, or any multitude of
laboratories; you can't rely solely on certification.
I've invited an expert speaker, Olive Wolfe, to show how lab data is
critical to a device’s efficacy claims. She will show why it's essential
to visit the lab personally to review day-to-day operations. She will
provide a checklist to be used to evaluate the lab’s performance and
operation onsite, and she will also show how this applies to new tests,
instruments and reagents.Ms. Wolfe of Clinical
Consultants, Inc.,
recorded the presentation on July 16, 2008.
To be successful with the FDA you need an
understanding of FDA's organizational structure, the framework and content
of the Food, Drug, and Cosmetic Act, and its related regulations. In the
absence of such knowledge, you cannot work effectively with FDA reviewers
and field investigators or advance as a professional in these fields.
This lively and informative course is designed to introduce you to the
basics of FDA regulation from the fundamentals to Agency organization and
priorities, premarket submissions, and enforcement. It will provide a
foundation for quality, professional interactions with FDA.
Presented by Janice Hogan on June 25, 2008.
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. Dr. Gail Radcliffe recorded the presentation
on June 11, 2008.
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, Dr. Robert Thiel’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. Presented
on May 21, 2008 by Dr. Robert Thiel
of Thiel Statistical Consultants.
Why
isn't the market uptake of your FDA-approved device greater or faster? FDA approval is a necessary, but not sufficient,
criterion for payer adoption. Third-party payers are the ultimate purchasers
of medical technologies and they establish various requirements for adoption
and set pricing levels. This e-Conference will help you understand payer
requirements, how to meet them,and how to overcome barriers to reimbursement.
Presented on April 23, 2008 by Mary Ann Clark of the
Burgess Group.
What's the difference between a Bayesian and a frequentist? Both are
statisticians, but ones with very different approaches to viewing data. In
this thought-provoking e conference designed for laymen you will hear
Dr.
Robert Thiel compare and contrast Bayesian and frequentist different
methodologies. You will never look at statistics the same way again.
Presented on April
9, 2008.
In this presentation we'll review the
complex process of device classification in Europe, how it dictates whether
or not a clinical trial is needed, and how it leads to the various pathways
of conformity assessment and CE marking of the device. Ms. Janette Benaddi
of Medvance Ltd provides
examples of how to interpret the directives and guidelines, and then applies her
experience in addressing some of the gray areas that exist within the
system. Presented on March 18, 2008.
Device Trials in
Central/Eastern Europe Clinical studies in Eastern Europe offer a smoother start-up, lower cost, and faster enrollment rate; but should you go there? Dr. Peter Goodenow has been managing device (and pharmaceutical) studies in Eastern Europe for many years. In this session he will give you practical knowledge
and helpful hints in using Central/Eastern Europe to accelerate study
start-up, maximize enrollment and obtain high quality data that can be used with FDA.
Presented by Dr. Peter Goodenow of
PharmaTrials Inc on March 4, 2008.
"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.
FDAAA did more than reauthorize user fees through 2012, it included some other very important provisions such as trial registration on www.clinicaltrials.gov, a streamlined third-party review system, increased post-market surveillance, a unique identifier system for devices, and more. This e-conference
focuses on the practical consequences for device companies.
Presented by Ms. Janice Hogan on February 28, 2008.
The Office of In Vitro Diagnostics is committed to educating inventors and manufacturers about
its requirements for approval. Concomitantly, manufacturers are
concerned and eager to learn about their expectations. In this e-conference
you will hear directly from Sousan Altaire on the Critical Path Initiative effort, Arleen Pinkos on the road to an artificial pancreas,
Kristen Meier on FDA's "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests", Reena Philip on gene expression for breast cancer prognosis, Elizabeth Mansfield on an FDA's "Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers", and Sally Hojvat on human specimen repositories. Presented by the staff of FDA/CDRH/OIVD
on February 19, 2008.
In this presentation, Mr. Mark Jones will review some of the biggest challenges to implementing electronic data capture in device trials. He will focus on device trial related issues, offer
solutions or approaches that can be used to address these problems, and most importantly recommend whether or not EDC is right for your trial. He 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.
Presented by Mr. Mark Jones of Fortress Medical
on February 5, 2008.
Negotiating Patient Flow and Cash Flow In this e-conference,
Dr. Thomas R Zimmerman Jr. discusses the relationship between patient recruitment and cash flow in a clinical trial. Dr. Zimmerman presents some useful rules of thumb: 1) sites should start recruiting patients three months before study start-up, 2) sponsors should estimate six months for pre-study tasks to allow for contract negotiations and IRB review, and 3) sites should budget 30 minutes or $200 for each data query. And finally he discusses some of the difficulties of making study budgets and determining when or if third-party insurers will pay for study procedures.
Presented by Dr. Thomas R. Zimmerman Jr. of
Johnston McGregor on January 23, 2008.
Dr. Cheryl Hayden of IlluminatedWorks Inc reviews the regulations for IVD trials, giving websites and valuable reference information for IVD trial designs.
Dr. Robert Thiel is on hand to answer statistical questions that came up during the QnA period.
Presented on January 8, 2008.
The Food and Drug
Administration Amendments Act of 2007 mandated registration of certain
device clinical trials in publicly accessible registries. In the first portion of this e-conference, Ms. Rebecca J Williams, Assistant Director of
ClinicalTrials.gov discusses how the database works, what trials must be registered, and the changes that have been made to accomodate medical device studies.
In the second, shorter, portion of this e-conference,
Dr. Nancy J Stark discusses the requirements of medical publishers and points out that their own standards prevent them from publishing any study that was not listed in a public registry. Presented on November 28, 2007.
Third in a four-part series on in-vitro diagnostics,
Dr. Robert Thiel discusses the basics of statistical design for IVD studies, including endpoints, distributions, cut-off values, upper limit of normals, ROC curves, effect of covariates, sensitivity and specificity, tests of hypotheses such a the old-fashioned way, non-inferiority, equivalent, and superior methods. Then he makes a comparison of traditional frequentist methods to Bayesian (adaptive) methods. If you are new to IVD trial design this is an e-conference you should not miss. Presented on
December 4, 2007.
Dr. Cheryl Haydenexplains how to design IVD trials with multiple endpoints such as short-term and long-term endpoints, serial samples, or single samples analyzed multiple times. She illustrates her points by presenting a fictitious trial for a biomarker and designs a trial to answer four questions: 1) are there specific subsets of patients who always have the marker or never have the marker, 2) how early in the disease process can biomarkers be detected, 3) does the circulating level of biomarker reflect the response to treatment, and 4) does a rising level of circulating biomarker indicate a recurrence or progression of disease? Presented on
November 6, 2007.
What is a data monitoring committee and when is it in your best interest to have one oversee
your trial? If you have a DMC, how should it operate and are you bound by its decisions? 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 e-
conference will be
helpful to you and your organization. Presented by Steven C. Schurr, Esq. on October 16, 2007.
One of FDA's top priorities is to "Increase our ability to identify, analyze, and act on post-market information in order to enhance the safety and effectiveness of medical devices and radiological products throughout their product life cycles." A post-approval study requirement could delay,
or even jeopardize, your PMA approval if you are not prepared to submit a protocol within 30 days of PMA approval. Study progress is posted under Post Approval Studies, and a failure to complete the study could result in enforcement remedies.
Presented by Mr. Jeffrey Shapiro, Esq., of Hyman, Phelps & McNamara, on September 19, 2007.
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 e-conference
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. Included on the CD is a Excel program developed by the speakerfor calculating
the scores.Presented by
Michelle Secic of Secic Statistical Consulting on
September 18, 2007.
Under the FDCA, a medical device may be sold only for the intended uses FDA has cleared or approved. If a firm promotes for a new intended use, FDA may allege adulteration or misbranding for failure to obtain a new 510k clearance or PMA approval. The Basic Rule: company-generated labeling, advertising, or using quotations or summaries of third-party material may not be used to promote a device for off-label use. In this event, Janice Hogan, Esq discusses the practicalities of the regulation and FDA's
discretion enforcement policies. Presented by Ms. Janice Hogan, Hogan & Hartson LLC, on
September 9, 2007.
Product
recalls are a reality. Knowing how to handle a recall can minimize what
could be devastating results for your company. A firm's
responsibilities in identifying, reporting, and managing a recall are
reviewed by Betty Collins, Director, Division of Enforcement, Office of
Compliance at FDA/CDRH. Insights on
the Health Hazard Evaluation process and how it
determines if you have a Class I, Class II, or Class III recall are reviewed
by Dr. Kimber Richter, a medical officer with the Office. Tips on Dos and Don'ts of the process
are also shared.
This e-conference was presented on August 14, 2007.
Because in
vitro diagnostic trials are structured differently than other device
trials, you need to understand those differences in order to meet regulatory
and marketing needs.
For example, you might compare results from your new diagnostic device to results from an existing assay, you might compare results to presence of disease, you might limit your subject selection to individuals who have the disease (enriched sample) or select from the general population, and statistical input will base the sample size on clinically significant changes, assay variability, and population
variability. There are more important elements, too, and you can learn about them in the e-conference presented by
Dr. Cheryl Hayden on August 9, 2007.
Premarket
approval applications are complex, lengthy, and expensive. No one person
writes a PMA, it is a team effort requiring input from safety, clinical, R&D,
manufacturing, marketing, and regulatory functions.
Gerald Prud'Homme Esq of
Hogan & Hartson LLC discusses the content requirements of a PMA, and more
importantly, the depth of detail and analysis you should present. Of special
value is a 20-point task list that take you from preclinical testing through
application approval, followed by a discussion of post-approval activities.
This valuable planning e-conference was presented on
July 24, 2007.
Drawing on first-hand knowledge of her home country,
Janette Benaddi, discusses the clinical study process in the UK. The process
is complex, beginning with approval from the UK competent authority, then
the NHRA (National Research Ethics Committee), REC (Regional Ethics
Committee), and finally the local institution. However, there are several
advantages of doing clinical studies in the UK: they speak English, they
have an excellent research reputation, there are specialized device RECs,
access to a large patient population, and the government is working actively
to improve the research approval process. Presented
by Janette Benaddi of Medvance Ltd,
on July 10, 2007.
IVDMIAs (in vitro diagnostic multivariate integrating
assays) are in-vitro diagnostic test systems that use clinical data to
empirically identify an algorithm and calculate a patient-specific result
using that algorithm and for which the results cannot be interpreted by a
physician without information from the test developer. For the nascent
genomic profiling industry, down-classification from Class III PMA to Class
II IVDMIA is an easier route to market, although if you work for a
laboratory developing proprietary test systems, and the test system is not
sold but the service is, suddenly being regulatory at all is a lot to
accept. In this e-conference the
significance and impact of FDA’s
draft guidance document on IVDMIAs,
and the public responses from laboratories, diagnostic companies,
clinicians, patient advocacy groups, and trade associations
is discussed.
Presented by Ms. Christine Bump
Esqof Hyman, Phelps & McNamara on
June 25, 2007.
510(k)
premarket notices are required for a limited number of specified Class I
devices, almost all Class II devices, and pre-amendment Class III devices for
which PMAs are not currently required. The key to successfully filing a 510(k)
is to establish substantial equivalence of your device to a device currently on
the market with regard to the same intended use, similar indications for use,
and the same or similar technological characteristics. Substantial
equivalence must be based on comparison to a legally marketed predicate. In
this e-conference, Janice Hogan discusses the 510(k) decision making process as
set forth in the Moohan Memorandum (#K86-3) and how to effectively apply it.
Presented by Ms. Janice Hogan,
Esq, on June 5, 2007.
The EuropeanCommission
finished their 5-year
revision process of the Medical Device Directives
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 main revision areas, including the
definition of software, authorized representatives, re-use of single use
devices, custom-made devices, European databank (EUDAMED), instructions for
use, Class I sterile/measuring devices, implantable devices, essential
requirements, classification, and clinical evaluation.Presented by Mr. Roger L. Gray
ofDonawa Consulting on May 22, 2007.
Investigational Device Exemptions--IDEs--are permissions to
conduct significant risk clinical studies. The successful IDE is achievable by
good advance planning, communication with FDA, a thorough and fair-minded report
of prior investigations, and compliance with relevant guidance documents. IDEs
are be required for clinical studies to support 510(k) notices of significant
risk devices and for all PMAs, which are by definition for significant risk
devices. Unfortunately, an increasing number of IDEs do not achieve approval in
the first round of questions. Ms. Patsy Trisler, JD, RAC, discusses the major
causes for failure and how to overcome them. Presented on May 8, 2007
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 e-conference is to teach you, as the sponsor, how to prepare yourself and
your sites for FDA inspections. Presented by
Mr. Steven C. Schurr, Esq, on
April 10, 2007.
Diagnostic test data, be the tests in vitro or
in vivo, should be analyzed per the FDA guidance document 'Statistical
Guidance on Reporting Results from Studies Evaluating Diagnostic Tests'.
Study designs may be cross-sectional (a snapshot of the population) or
case-control. In a group of cases--individuals with the disease or condition
under study--and a matching group of individuals who are disease or condition
free--controls--are compared for characteristics. Then the test system is
compared to the truth, a perfect standard, or an imperfect standard. You can see
the statistical complexity and Michelle Secic of Secic Statistical Consulting
explains them easily. Presented on March 6, 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 should follow exactly from the protocol, collecting no more and no
less data. 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; and given that the average data query costs
$200 to resolve, they can bring an otherwise
well-designed budget into overrun. Presented by
Dr. Nancy J Stark on
February 27, 2007.
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. 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 e-conference, Dr. Garvey
provides an overview of how
the FDA advisory
panel process works and guides
you in preparing for a panel meeting. Presented
February 13, 2007.
The job isn't finished 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. You'll
want to begin with the end in mind, writing an outline of the manuscript
even before starting the clinical trial; thinking about the message you want
to convey and who you want to tell it to.
Surprising to some of us, publishers have standards of their own to follow,
and Ms. Bannick tells us what they are and how we can meet them before we
start writing. Presented by
Karen Bannick of Bannick Consulting LLC on
January 23, 2007.
Canada
is becoming a major force in the North American medical device industry.
Regulations specific to devices were passed under the Canadian Food & Drug
Act in July, 1998. In this e-conference, Ms. Linda Lindsay brings a
sponsor's perspective as she presents an overview of Canadian medical device
regulations and then focuses in on the specifics of implementing clinical
trials. Presented by Ms. Linda Lindsay
of St. Jude Medical on
January 10, 2007.
AClinical Evaluation
is the European term for using existing literature data in lieu of a new
clinical trial to to verify the safety and
performance of a medical device. It should begin early in
the device development process and leads naturally to a decision as to
whether or not a clinical trial is necessary.
This e-conference is intended to demystify the process for Clinical
Evaluations and clarify when a
new clinical investigation is
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 of Medvance Ltdon December 5, 2006.
Registries are used by companies for internal tracking of
utilization and outcomes. The design of registries is as
varied as any other category of clinical trial, some designs are better than
others. In this e-conference theplanning, implementation,
and management of registries is discussed by
Dr. John Pandolfino, IRB co-chair and Associate Professor at Northwestern Medical
Faculty Foundation. 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 is discussed
by Dr. Elise Berliner of the Agency for Healthcare Research and Quality.
Moderated by Anne Marie Murphy,
Esq, the e-conference was presented on November 21, 2006.
FDA deliberately focuses on predominant device companies to use them as
examples for the rest of us. In this e-conference 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
deserve protection from misuse or
misappropriation. For example, you may own trademarks, copyrights, patents,or
proprietary information such as customer/vendor lists, pricing
information, procedures or quality systems. This
e-conference will
address the various types of intellectual
property, the risks associated with utilizing them in research,
specific protections granted by patents, copyrights, and
trademarks, and other legal
methods (such as nondisclosure agreements and contracts)
to protect them. Finally, the speaker will discuss
legal remedies, should they be necessary.
Presented by Mr. Steven C. Schurr, Esq on October 31,
2006.
The
new revision of the EU Medical Device Directive contains important
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
of Donawa and Associateson October 12, 2006.
The Global
Harmonization Task Force (GHTF) is a voluntary international organization
comprised of regulators and industry representatives. The
GHTF is intent on
developing statements (i.e., documents) and international
cross-checks for bringing medical devices to global market.
The speaker will discuss the
existing documents as well as future directions for the
GHTF. Presented by Dr.
Ronda Balham, a former Executive Secretariat for the Global
Harmonization Task Force (GHTF) and currently of
Donawa and Associates
on September 19, 2006.
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, the speakers
will explore the difficulties and key pathways to gaining
reimbursement for new medical technologies from the Centers for Medicare and
Medicaid Services (CMS). They will help you understand
the system and learn how to work within it. Presented by
Kirk L. Dobbins, of Counsel(Hyman,
Phelps & McNamara), Teresa Lee,
JD (ADVAMED), Dr. Elise Berliner (AHRQ), and Dr. Marcel E Salive (CMS)
on
September 7, 2006.
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
e-conference covers the European Regulatory System for Medical
Devices and how the Medical Device Directive
affects your relationship with Notified Bodies.
He will review the importance of defining the intended use for the
product; how to select the right Notified Body,
establish an overall plan for the cooperation between the
parties; organize documentation for compliance of medical devices; document quality
system, and plan and carry out Notified Body audits.
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
and currently of the
Copenhagen Medical Devices Consulting. Presented on August 29, 2006.
Human tissue, such as cartilage and demineralized bone matrix are used in a
number of medical products. Yet the European and United States philosophies
for regulating human tissue are quite different: Directive 2006/17/EC
provides new direction in the EU, in the States human tissue is not
regulated by FDA.
The
speaker will
address the current framework and regulations regarding human tissue. Then she will overview
the new ISO requirements regarding
animal tissue used in medical devices. Presented by Ms. Eliane Schutte,
MSc,
of Signifix
on July 18, 2006.
Japan has a new medical device
Good Clinical Practice regulation and it is different from the
ISO or US standards. Revised in 2005, the regulation was followed by several
supplemental notifications.
This e-conference presents a comprehensive overview of the present state
of affairs.
Presented by Ms. Nobuko Matsunaga, Chief
Regulatory Officer of Japan MDCon July 11, 2006.
Structuring a clear contract between sponsors, sites, and
CROs is critical to the successful implementation of a clinical trial.
Poorly designed contracts may result in needless arguments if events turn
bad. In this e-conference the speaker 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.
He 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
on June 27, 2006.
In
this 3-hour e-conference FDA's Office of In-Vitro Diagnostics discusses
three topics that are critical to your firm's diagnostic device
development. In the first session, Sally Hovjat, PhD, gives an overview
of in vitro diagnostic devices, discusses their unique properties, and
reviews the applicable regulations. In the second session, Tonya A
Wilbon provides an overview of the quality system regulation for medical
devices and how OIVD expects it to be applied to diagnostics. In the final
session, Sousan S Altaie, PhD, discusses the pre-IDE process and how it
applies specifically to in-vitro diagnostic devices. Still relevant today,
this e-conference was presented on June 13, 2006.
Patient-reported
outcomes are commonly used to report symptoms when there are no usable signs
to substantiate disease or condition improvement. Symptoms are things that
are not 'right' in the body but for which there is no measurement or which
cannot be readily seen by another person; for example, pain, chills,
achiness, sweats, weakness, tiredness, or shortness of breath are all
symptoms that have no good measurement. Signs are things that are not
'right' in the body but which can be readily measures, such as fever or
glucose level. The Center for Devices
recently endorsed the draft guidance “Patient-Reported Outcome Measures: Use
in Medical Product Development to Support Labeling Claims."
In this e-conference, Ms Michelle Secic of
Secic Statistical Consulting,
discusses
how patient diariescan be used to capture primary endpoints, how to develop
and validate them, and the special statistical considerations that apply to
their data.
The
handouts includeaBinder of Patient Diaries – a
compilation of hands-on examples of what FDA wants to see.
Presented by Ms. Secic on May 23, 2006.
In November of 2005 and June in 2006, FDA presented e-conferences in which they
proposed that device manufacturers develop quality systems to maintain
control of their clinical study activities. They
recommended using the already
required Quality System Requirements found in 21 CFR 820.
Since then, the2008 draft version of
the next ISO 14155 (Clinical
investigations of medical devices for human subjects--good clinical
practices) has been released, and it requires that all clinical studies be conducted
under a sponsor's quality system.
What might such a quality system look like? You
can find out if you take this e-conference.
Presented by Dr. Nancy J. Stark on May 2, 2006.
The staff of Bioresearch Monitoring
for CDRH
discusses
how
sponsors can ensure the quality of device clinical trials. including
approaches for IRB
oversight of device clinical research; how IRBs,
investigators, and sponsors are responsible for protection of human subjects;
what to look for when selecting qualified investigators;
suggestions for optimizing the protocol and data collection;the importance of training for the research team;
the importance of adequate monitoring and ensuring investigator
compliance; how to apply the seven primary Quality
System Inspection Technique (QSIT) sub-systems to clinical research;
and how to apply a Corrective and Preventive Action (CAPA) subsystem
to clinical research.Director Michael
Marcarelli gives the introduction, followed by Marian J Serge, RN discussing
Human Subject Protection Issues. Next, Jean
Toth-Allen, PhD discusses Building Quality into Clinical Trials and
finally Cynthia Harris, MS, RN discusses Adapting a
Quality System to Clinical Trials.
Presented by the staff of FDA/CDHR/BiMo, November 22, 2005
Your
Cart Contents: Number
Items: 0
SubTotal: $0.00
