Study/Protocol Design
[09-13] HCUP Database
[07-8] Data Monitoring Committees
[07-2] Paper CRFs
[06-5] Intellectual Property
[06-2] Contracts
The Fine Print:
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Copyrights and intellectual property rights are retained by Clinical Device Group. You may view a CD as often as you like, share it with your company colleagues, and retaine it for future training within your firm. CDs may not be copied, shared with individuals outside of the purchasing firm, or broadcast over private webcasts.
Certificates of Attendance and CEUs will be issued upon request and after return of Feedback Form.
What are e-Conferences?
eConferences are recordings of advanced level topics in medical devices, usually with an expert guest speaker. Most were recorded via webcast with a live audience, you will hear the questions and answers throughout the event. The typical format is a 60-minute presentation and about 30-minutes of Q&A.
The newer presentations are studio recorded, which gives better sound and video quality than webcasts. Questions are solicited from experts prior to the presentation and used as thought experiments to keep the presentation actively challenging. The typical format is a 60 to 90-minute presentation with an invitation to post your comments and questions on a blog-site linked to the presentation.
Build An eConference Library
We recommend you build a library of CDs for review and for new hires. There are many advantages of CD training: you can watch the presentation on your own schedule, stop and start it if you are interrupted, listen individually or in a group for discussion.
We are constantly adding new topics, updating topics, and dropping older events so that you can be sure the content of any CD, now matter what the year of presentation, is relevent today.
All CDs come with pdf copies of the PowerPoint presentation, supporting handouts, recorded presentations, a Feedback Form, and appropriate player. Certificates of Attendance and CEUs are available on request; attendance is on your honor.
We hope you enjoy the show.
[11-1] Risk-Based Monitoring for Device Trials
22 November 2011
$400
In August 2011, FDA withdrew the 1988 "Guideline for Monitoring of Clinical Investigations", and in doing so withdrew the very concept of pre-study, study initiation, routine study, and study close-out activities. Instead of monitoring at these highly recognized milestones, FDA now encourages linking on-site monitoring visits to critical data and processes that have gone "high-risk" as identified by a centralized electronic data capture system. This fundamental shift in how we look at study management is described in a new draft guidance for industry, "Oversight of Clinical Investigations—Risk-Based Approach to Monitoring" (Aug 2011).
The guidance flies in the face of the new international standard ISO 14155 "Clinical investigations of medical devices in human subjects—good clinical practices" (2011) and is only marginally consistent with ICH-GCPs. Why is FDA encouraging such a radical and cardinal shift in our approach to study management? Will we, once again, have to rewrite our quality management systems for clinical investigations? Is there a career future for monitors? And most importantly, how can device firms leverage the new guidance to reduce monitoring costs? This two-hour pre-recorded presentation walks you through the new guidance document and discusses these and many more disruptive questions. Designed and recorded by Dr. Nancy J Stark on November 22, 2011. Click here for details.
[10-6] The Critical Role of Risk Management in Clinical Trials
4 Aug 2010
$400
In this e-conference you will learn how to apply risk management concepts to the clinical research process. You will learn how risk management allows a manufacturer to make more objective and informed decisions about when to initiate, suspend, restart, modify or stop a clinical study. And you will learn how specific risk management tools can assist in these clinical study decisions. Presented by Mr. Barry Sands on August 4, 2010. Click here for more details.
[10-5] Investigator Responsibilities: Compare & Contrast-FDA & ISO
8 June 2010
$400
Investigators are expected to make certain contributions to clinical investigations. But there are also many duties they typically take on that are not identified in any regulation or guidance. Some are standard practice, others are bad ideas. In this session you will learn the subtleties of investigator responsibilities, learn how sponsors can help assure investigator compliance, and see how the States compare with international expectations.
The first half of the presentation will be a discussion of the FDA guidance document given by a bona fide medical device investigator. The second half will be a comparison to the ISO/DIS 14155 standard, given by Clinical Device Group. Presented on June 8, 2010 by Dr. John Pandolfino and Dr. Nancy J. Stark. Click here for more details.
[10-4] The Latest in Canadian Regulations
28 April 2010
$400
There are many advantages to implementing a device trial in Canada. Canada's thriving device industry promises a host of trained investigators. It costs less than European or Asian trials. Regulations are easier than the States in many respects. Investigators speak English, are trained in Western medicine, and are trained in good clinical practice. There are no excise taxes on the sale of devices, in case you're doing a post-market study.
The presentation will begin with an overview of the Canadian Medical Devices Regulations (MDR), the Investigational Testing Authorization (ITA) provisions of the MDR, common pitfalls in obtaining approval, and privacy legislation in Canada. The objective of this presentation is to give you all the information you need to decide whether or not to use Canada in your next clinical trial. Presented on April 28, 2010 by Mr. Fabio De Pasquale. Click here for more details.
[10-3] What's Involved in Data Management?
3 March 2010
$400
Data management encompasses the span of time from the moment the case report forms walk in the door to the moment the final database is sent to the statistician. It involves all the activities of logging in the forms, preparing a database application to receive the data, designing in edit checks to protect against entry errors, entering the data, choosing between full and partial double-data entry, generating data queries to clean the data, validating the data, writing code for administrative reports, and exporting the data to the statistician's SAS program. Furthermore, it must be Part 11 compliant. All of this is necessary so the sponsor can claim data integrity. ISO/DIS 14155 (2009) makes it clear that that burden rests with the sponsor. In this e-conference we will discuss the “how-to” of implementing these steps. Presented on March 3, 2010 by Mr. Wessam Sonbol. Click here for more details.
[10-2] What Every Monitor should Know about Design Controls
3 February 2010
$400
Many clinical research professionals do not fully understand Design Controls or the questions they should be asking R&D concerning the safety and the design of the device. This information is important in the clinical protocol, important to be captured during the study and in some cases should be passed onto the clinical sites to ensure correct application of the device.
In this e-conference we will discuss what questions you should ask your R&D department and what documentation you should get from them before you initiate a study. You'll learn how to monitor for design control elements. And you'll learn about real-life situations in which studies didn't provide the data required by FDA. Presented on February 3, 2010 by Mr. F. David Rothkopf. Click here for more details
[10-1] BSI on Notified Body Expectations for Clinical Evaluations Reports
20 January 2010
$400
In Europe, a clinical evaluation is always required The 2007 amendment to the European Medical Device Directive came into force in March 2010, and it required a full clinical evaluation (CE) to be conducted as part of the process to market a device. Since Notified Bodies will review the results of the evaluation, it is important that the clinical evaluation is conducted appropriately, correctly and robustly. The clinical evaluation determines whether or not a new clinical investigation is required. Questions will be clarified from a Notified Body perspective by Dr. Gert Bos and Dr. Suzie Halliday of the British Standards Institute. Presented on January 20, 2010. Click here for more details.
[09-18] FDA's New Attitude toward Medical Software
2 December 2009
$350
FDA's policies regarding regulation of medical software are rapidly evolving. As the agency considers expansive regulation of new types of software, software development and validation methodology, and expectations of performance and reliability, it is important to understand the scope of potential regulation and the level of regulation that may be applied to your device. Participants in this course should gain an understanding of the current framework for regulation of medical software, the history of FDA regulation of software products, and the potential for changes in FDA's future regulation of medical software. Presented on December 2, 2009 by Janice Hogan, Esq. Click here for more details
[09-17] A Walk through the GHTF Study Group 5 Clinical Evaluation Document 23 November 2009
$350
In this enjoyable and practical e-conference, we will use a case study to demonstrate how to conduct a step-by-step clinical evaluation according to the GHTF Clinical Evaluations document. We will use the guidance documents available and a flowchart of the process. You will learn to understand the basics of conducting a clinical evaluation and what to put into the final report of the clinical evaluation. Presented by Ms. Janette Benaddi on November 23, 2009. Click here for more details.
[09-16] Registry Study Designs
18 November 2009
$350
In medicine, “Science tells us what to do; guidelines what we should do; registries what we are actually doing”. Registry studies are appropriate in post-commercial settings. They are not a cheap version of randomized controlled studies, they are sophisticated studies in and of themselves and are especially appropriate for gathering the effectiveness data needed for reimbursement. Dr. Nancy J Stark will review the methodology of registry studies, discuss application of FDA and HIPAA regulations, recommend good clinical practices, and distinguish between registries for evaluating patient outcomes and registries for region, incidence, or other listing purposes. Presented on November 18, 2009. Click here for more details.
[09-15] Cost Effective Analysis and Medical Device Utilization
4 November 2009
$350
Better features and benefits won't be as important in the future. A successful device will be one that gives more years of quality life for the expenditure. Cost effectiveness frightens us because it brings up images of health care rationing. It examines the costs and outcomes of comparator devices: the idea is which device costs the least for a year of quality life. Forewarned is forearmed, in this e-conference you'll learn how to do a cost effectiveness clinical study and stay ahead of everybody else. Click here for more details. Presented on November 4, 2009 by Dr. Vincent Jaeger.
[09-14] Medical Devices and Comparative Effectiveness Research
7 October 2009
$350
Comparative effectiveness research is the process of comparing one treatment option to another to determine which is more effective. It is old-school clinical research, usually done on commercially available devices, but with the critical new twist of a legal mandate.
The American Recovery and Reinvestment Act of 2009 designated ~1.2 trillion dollars in grant money to conduct comparative effectiveness studies; about 1/3 is administered by AHRQ and 2/3 is administered by the National Institute of Medicine. Your investigators, as non-profit entities, can apply for this funding. By working with them, you can have indirect access to the funding, too.
Take this e-conference to learn why everyone is so concerned with comparative effectiveness and how to apply the research methods to your own devices. Click here for more details. Presented on October 7, 2009 by Dr. Elise Berliner.
[09-13] The HCUP Database, Basing Protocols on Healthcare Data
23 September 2009
$350
The Healthcare Cost and Utilization Project, HCUP, is a family of health care databases which are available to you for research and development. HCUP databases bring together data from state data organizations, hospital associations, private data organizations (i.e., insurance companies), and the federal government to create a national information resource of patient-level health care data.
Take this e-conference to learn more about accessing HCUP data for use in protocol design, site selection, inclusion/exclusion criteria, risk analyses, and other critical study design issues. Click here for more details. Presented on September 23, 2009 by Dr. Claudia Steiner of AHRQ.
[09-12] The Button Builders: What to Expect from Your Statistician
9 September 2009
$350
Appropriate software and computing power are indispensable tools to clinical trials and, once programmed, a well-structured set of clinical trial final reports can be generated easily. However, someone has to set up all the unique calculations, data manipulations and output formatting that makes this possible. You may think it happens automatically, but your statistician is doing a whole set of tasks behind the scene in preparation for these easily generated reports. Take this e-conference to learn the processes and steps involved in making these important statistical reports – what’s behind that button. Click here for more details. Presented by Michelle Secic of Secic Statistical Consulting on September 9, 2009.
[09-11] How to Validate Device and Computer Software
8 July 2009
$350
Validating device and computer software is a complex problem that in some ways is never done. This e-conference will point out common problems, give an overview of recent enforcement activity, and then present a comprehensive methodology for managing computer software validation and avoiding common traps. Presented by Mr. Tayson M. Mew, President of Ofni Systems, on July 8, 2009.
[09-10] Japanese Reforms for Device Approval (Shonin)
20 May 2009
$350
In this informative and useful event, you will learn about the new submission categories, overviews of each Shonin category, and the role of clinical trial data for each of them. Presented by Ms. Nobuko Matsunaga, Chief Regulatory Officer of Japan MDC on May 20, 2009.
[09-9] Working Effectively with CROs
6 May 2009
$350
Outsourcing to a CRO is an important and costly decision for your company. Steven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will discuss the regulatory, legal and financial pitfalls in the use of a CRO for a research project and teach you how to protect your organization from them. Presented by Steven C. Schurr on May 06, 2009.
[09-8] Working with Notified Bodies
22 April 2009
$350
>Not all European Notified Bodies are the same. In light of the recent proposed updates on the Medical Devices Directive, in this e-conference we present the information you need to select the best fit Notified Body and how to work with it. Presented by Mr. Poul Schmidt-Andersen, B.Sc. EE, B.Comm. from Denmark on April 22, 2009.
[09-7] The Medical Device Recast and ISO 14155 Revisions
8 April 2009
$350
It's easier to start a device trial in Europe than in the States and easier to get to market. The regulatory barrier is lower, the review barrier is lower, and CE Marks are easier to get than 510k approvals. If you have an innovative device, chances are you'll do your trials and go to market in Europe first. This course is more than theoretical, you will learn in practical terms what MDD changes were planned and which are likely to survive. Presented by Dr. Gert Bos from The Netherlands on April 08, 2009.
[09-6] Designing Studies to Affordable Sample Sizes
25 March 2009
$350
The sample size of your study is a result of many non-statistical influences, and having a well-powered study is not necessarily FDA's goal. The objective of this event is to understand how design choices and other factors influence sample size and how to use them to your advantage. Presented by Dr. Robert P. Thiel on March 25, 2009.
[09-5] FDA Inspections of Sponsors
19 March 2009
$350
This presentation focuses on a number of the issues that typically arise during the challenging and important event of an FDA inspection. It offers suggestions for increasing the likelihood of a favorable outcome; presented by Mr. Jeffrey Shapiro, Esq. and Mr. Brian Donato, Esq., from Hyman, Phelps & McNamara Law firm in Washington, D.C. on March 19, 2009.
[09-4] Part 11 Compliance for Your Access Database
18 February 2009
$350
In this e-conference you will learn how to implement 21 CFR Part 11 requirements in an MS Access database. This presentation will provide the instructions, materials and documentation to ensure full compliance in Access. Presented by Mr. Tayson M. Mew, President of Ofni Systems, on February 18, 2009.
[09-3] How to Make Excel Part 11 Compliant
4 February 2009
$350
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.
[09-2] Revisions of Japan's GCP Regulations
21 January 2009
$350
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.
[09-1] Big Data Management for Small Companies
15 January 2009
$350
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 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.
[08-15] Biocompatibility Risk Management for Clinical and Regulatory Professionals
3 December 2008
$300
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.
[08-14] Case Studies for Reimbursement Codes
19 November 2008
$300
Technology reimbursement is driven by a coding process: if a "code" exists for your technology, reimbursement will be no issue. If there is not pre-existing code, as there won't be for new technologies, reimbursement becomes a major strategic issue. This presentation provides a framework for determining when it is necessary to obtain a new reimbursement code, how to go about getting the code, 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.
[08-13] Faster Route to Japanese Market with New Standards
12 November 2008
$300
Can Ninsho get me to market faster? In Japan a new regulatory affairs law (PAL) was recently implemented and new 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 than other categories. 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.
[08-12] ISO 13485: Can it be applied to Clinical Trials?
8 October 2008
$300
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.
[08-11] Setting Up Registries: Reason and Roadmaps
10 September 2008
$300
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.
[08-10] Why and How to Monitor a Clinical Lab
16 July 2008
$300
Your company is doing a clinical trial and the endpoints depend on 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. We'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.
[08-9] An Introduction to FDA and the Food, Drug and Cosmetic Act
25 June 2008
$300
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.
[08-8] Aiming for CLIA Waiver
11 June 2008
$300
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.
[08-7] The Risks and Benefits of Adaptive Trials
21 May 2008
$300
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 in this presentation is to tell you how to apply adaptive designs the FDA way. He’ll 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.
[08-6] Getting to Medical Device Reimbursement
23 April 2008
$300
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.
[08-4] FDAAA—The FDA Amendment Act of 2007
28 February 2008
$300
"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.
[08-3] EDC in Device Clinical Trials
5 February 2008
$300
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.
[08-2] Negotiating Patient Flow and Cash Flow
23 January 2008
$300
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.
[08-1] Mastering IVD Clinical Trials: Regulatory Issues
8 January 2008
$300
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.
[07-10] Mastering IVD Clinical Trials: Basic Statistics for IVD Trials
4 December 2007
$250
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 so you can understand the significant difference. If you are new to IVD trial design this is an e-conference you should not miss. Presented on December 4, 2007.
[07-9] Mastering IVD Clinical Trials: Multiple Endpoints in IVD Trials
6 November 2007
$250
Dr. Cheryl Hayden explains 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
[07-8] The Establishment and Operation of a Data Monitoring Committee
16 October 2007
$250
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.
[07-7] Procedures for Handling Section 522 Post-Approval Studies Imposed by PMA Order
19 September 2007
$250
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.
[07-6] Calculating and Reporting SF-36 Scales
18 September 2007
$250
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 speaker for calculating the scores. Presented by Michelle Secic of Secic Statistical Consulting on September 18, 2007.
[07-5] Mastering IVD Clinical Trials: The Basics
9 August 2007
$250
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.
[07-4] FDA Inspections: Sponsors and Your Sites
10 April 2007
$250
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.
[07-3] Statistical Considerations for IVD Studies
6 March 2007
$250
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.
[07-2] Designing Paper-Based Case Report Forms
27 February 2007
$250
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.
[07-1] How to Prepare for an FDA Panel Meeting
13 February 2007
$250
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.
[06-8] Getting to CE Mark, The Literature Route
5 December 2006
$250
In Europe, it is often possible to use a literature review to meet the regulatory requirements of a CE Mark. The literature review addresses the question of safety and performance of a medical device with respect to its intended use. The review should begin early in the device development process and lead naturally to a decision as to whether or not a clinical trial is necessary This e-conference discusses the process for getting a CE Mark via the literature route and clarifies 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 Ltd on December 5, 2006.
[06-7] How to Do Post-Approval Registry Studies for Medical Devices
21 November 2006
$250
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 the planning, 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.
[06-5] Protecting Your Intellectual Property in Research Contracts
31 October 2006
$250
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.
[06-4] Getting CMS Reimbursement for Medical Technology Products
7 September 2006
$250
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.
[06-3] Japan's New Medical Device GCP Regulation
11 July 2006
$200
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 MDC on July 11, 2006.
[06-2] Contracts for Sponsors, Sites and CROs 27 June 2006
$200
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. 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 on June 27, 2006.
[06-1] Using Patient Diaries to Capture Primary Endpoints
23 May 2006
$400
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 diaries can be used to capture primary endpoints, how to develop and validate them, and the special statistical considerations that apply to their data. The handouts include Binder of Patient Diaries a compilation of hands-on examples of what FDA wants to see. Presented by Ms. Secic on May 23, 2006.
