Workshops - Clinical and Regulatory Training from CDG... |
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Our Mission: The Workshop: Learning Management: A Learning System is an online application that tracks your participation in the whole event, including downloading and reading workshop materials, actively participating in the lecture, taking the quiz, and providing workshop assessment. It provides you with a complete transcript of your participation. Instructor: Satisfactory Completion Requirements: System Requirements: Auditing the Workshop: Certificates are Issued in the Registered Learner's Name: |
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Webcast fee $500 Additional registrations
We're waiting for translations and a final vote before the International Standards Organization can publish the next revision of ISO 14155, but our fingers are crossed for first quarter 2011. Meanwhile, we will take a hard look at the Final Draft International Standard (FDIS) in this workshop to see what this sweeping standard has in store for us. The Part 1 and Part 2 standards from 2003 were combined and completely redesigned to make a single, comprehensive standard. Harmonized with the ICH-GCPs, the tag line "good clinical practices" is meant to signal the world that ISO 14155 is now the document to follow for international clinical studies of medical devices. The approach is to discuss clinical research from a project management perspective and then identify the responsibilities of the sponsor and principal investigator in the last two sections. The contents of the protocol, case report forms, investigator's brochure, final report, and study documentation are specified in separate annexes. Other major changes include the emphasis on risk management. A sponsor cannot be compliant with ISO/FDIS 14155 without a fully functioning risk management system integrated into the clinical plan. Included in risk management is the requirement to record and report device deficiencies. If you are among the many who felt reporting all adverse events was too much, you may be frustrated to learn there is more reporting required now. Learn more-> Dates: Please check the calendar on CDG's home page for presentation dates. |
Total Study Budget: Site, Center, Sponsor - Keeping Study Costs under Control A MODEST DEVICE STUDY COSTS A MILLION DOLLARS IT STARTS WITH THE PROTOCOL Consider the following study plan: 100 subjects will be implanted with a vascular access port; they will use the port for the duration of their primary treatment, and then have the port removed. Let's say the protocol requires still photographs from a final fluoroscopy and radiologist's report at the time of implant to confirm catheter and port position; and still photographs from a final fluoroscopy and radiologist's report at the time of explant to determine possible migration. These are procedures that are outside the normal standard of care. Learn more-> Dates: Please check the calendar on CDG's home page for presentation dates. |
CD $550 Introduction to Medical Device Regulation: US  The Food and Drug Agency (FDA) gains it authority to govern medical devices in interstate commerce from the Food, Drug, and Cosmetic Act. Devices have been regulated since 1938, but the clinical investigation of devices in human subjects wasn’t regulated until 1980. There are only two things that can go wrong with a medical device: it can be adulterated or it can be misbranded. Adulterated speaks to the issue of filth, contamination, or toxic leachables being present in or on a medical device. Misbranding speaks to the issue of false or misleading statements, including statements made on websites or the juxtaposition of images. The surgical scalpel below is adulterated because it is not sterile (green bacteria) and mislabeled because the cutting edge has burrs (should be sharp). The objective of the workshop is to learn the basics of FDA device regulations and how to determine if you need a clinical study in order to get FDA clearance. Learn More -> This is an introductory workshop and focuses on US regulations. A complimentary workshop focusing on European regulations is also available. Dates: Please check the calendar on CDG's home page for presentation dates. |
Introduction to Medical Device Regulation: EU  The European Union’s (EU) government, located in Brussels, consists of a Parliament, Council, and Commission. The Council sets the general direction and priorities of the Union. The Commission proposes directives consistent with the priorities set by the Council. The Parliament and Council jointly approve the directives, which are then issued as law by the Council. When the EU sought to set up a review and approval system for medical devices, they wanted to take advantage of existing governmental institutions. The idea of using what was already there was called the New Approach. Under the New Approach, the European Council issued three primary directives (laws). These are the Active Implantable Medical Device Directive (AIMD) 1991-385-EEC, the Medical Device Directive (MDD) 1993-42-EEC, and the In Vitro Diagnostic Directive (IVD) 1998-79-EC. The directives are actualized through three bodies unique to each Member State (country): the Regulatory Body (say, Health and Human Services) which implements the directives, the Standards Body which writes the ‘regulations’, and the Notified Body which inspects and enforces the directives and regulations. Because these bodies were unique to each country there was still considerable variability across Europe. So much so that the New Approach was challenged in 2009 and was nearly dissolved. The concept prevailed, however, and is stronger than ever. The objective of the workshop is to learn the basics of European regulations and how to determine if you need a clinical study in order to get market your device.. Learn More -> This is an introductory workshop and focuses on EU regulations. A complimentary workshop focusing on US regulations is also available. Dates: Please check the calendar on CDG's home page for presentation dates. |
CD $550 OnDemand $500 Registries Studies for Medical Devices  Registry studies are observational studies in which the events which happen to subjects with a specific disease or condition are recorded without predefined treatment. This is in opposition to interventional studies in which subjects with a specific disease or condition are treated per an approved protocol and data are collected about the treatment. We say that registry studies are 'data driven' as opposed to interventional studies, which are 'protocol driven'. One common application for registry studies is in the conduct of Section 522 post-market approval studies. This whitepaper and the accompanying workshopare is based on " Registries for Evaluating Patient Outcomes: A User's Guide" developed by the Agency for Healthcare Research and Quality, which is the best ‘how to’ guide available for post-market approval studies. You will learn when, why and how to implement a registry study in this workshop. Learn More -> Dates: Please check the calendar on CDG's home page for presentation dates. |
 IDE Applications--In the US, permission to conduct medical device clinical trials is obtained in one of two ways: 1) through a full IDE process for significant risk (SR) devices in which FDA reviews the protocol and approves the IDE application, or 2) through an abbreviated IDE process for non-significant risk (NSR) devices in which the IRB acts as FDA's surrogate and reviews and approves the protocol. In 2007, the number of first-cycle approvals for IDE applications had dropped to under 40%. This means 60% were returned with questions, according to the latest available annual report from the Office of Device Evaluation. A CDG poll revealed the majority of questions were regarding protocol or study design, followed by the statistical analysis plan and sample size calculations. In this workshop you will learn how to prepare a significant risk IDE application for FDA, with the goal of achieving first-cycle approval. Learn More ->Dates: Please check the calendar on CDG's home page for presentation dates. |
CD $550 OnDemand $500 Project Management for Clinical Trials Workshop  The purpose of project management is to control the project and correct problems before they are uncorrectable. Without project management many trials evaporate into a cloud of no-enrollment and absence of data. We will apply the six familiar steps of project management, [1] project definition, [2] project schedule, [3] resource allocation, [4] cost estimates, [5] project maintenance, and [6] project close-out, to the process of implementing a clinical study. This is a hands-on, problem solving workshop where you’ll grapple with real-life clinical trial problems and learn practical solutions. Bring your pencil, paper, and calculator. You will learn to plan a clinical study so your management will be forewarned, and analyze the progress of the study so management can take corrective action. Learn more ->Dates: Please check the calendar on CDG's home page for presentation dates. |
 FDA has suggested device companies apply the quality management system regulations to clinical trials, the ICH-GCPs have always said clinical research functions should have procedures for conducting clinical trials, and now the ISO/FDIS 14155 (2010) ‘Clinical investigation of medical devices in human subjects—good clinical practice’ standard requires procedures and a quality management system for clinical trials. In this workshop we’ll walk through the steps of creating a quality management system for clinical research, considering your customer base and work products, and examine models for the most important standard operating procedures. You will learn how to create a quality management system for your clinical research department. Lern more -> Dates: Please check the calendar on CDG's home page for presentation dates. |
 A good study begins with team consensus on what you want to claim about your technology when the study is over. Writing a clear statement about efficacy or performance takes thought and debate. The difficulty is that you must commit today to what you will call a success tomorrow. It helps to think in terms of the natural order of progression from want-to-have claims to substantiated claims easy-to-get claims to difficult-but-more-profitable claims. You’ll go for easy claims first if yours is a start-up firm; you may aim for the more difficult claims first if your firm is well-funded and experienced. In this workshop, we’ll start by assessing the outcomes measures for product success or failure, then look at the objectives for the study, the primary and secondary hypotheses, the primary and secondary endpoints, and how they will be measured. These issues make up the creative heart of the study, but next we must deal with the administrative text that gives the protocol standing. Then finally we’ll take a layman’s look at data analysis.You will learn how to write a protocol that is consistent with FDA and international expectations. Learn more -> Dates: Please check the calendar on CDG's home page for presentation dates. |
 Adverse event reporting is one of the more difficult aspects of conducting a medical device clinical trial. The US rules are different from drugs and from Europe. For example, in the States only adverse device effects are reportable (unless specifically required by FDA), while in Europe all adverse events are re portable, device related or not. And in the States, clinical trials are regulated according to risk, non-significant risk studies require only IRB approval to be initiated. But in Europe, all clinical trials are created equal and the same approval process is required no matter what the risk level of the study. The recording and reporting rules for the US and EU are compared and contrasted in this workshop. The goal of this workshop is to learn a decision-making framework that will facilitate correct adverse event recording and reporting, no matter where your study is conducted. Learn more ->Dates: Please check the calendar on CDG's home page for presentation dates. |
 Different from adverse events, a deviation is an unplanned departure from the protocol; injury to subject or caregiver is not an issue. An amendment is a planned and approved change to the protocol, including a design change to the investigational device. Adding to the confusion, IRBs prefer to include the concept of non-compliance in the mix. A non-compliance is a departure from the regulations. The recording, reporting, and prior approval requirements are complex, convoluted, and not gathered tidily together in one place. In this workshop you will learn how to distinguish between deviations, amendments, and non-compliances and to understand the recording and reporting requirements of each. Learn more -> Dates: Please check the calendar on CDG's home page for presentation dates. |
CD $550 OnDemand $500  Permission to conduct clinical trials and permission to commercialize are two of the most important approvals you'll need from FDA. In this 3-hour workshop we'll examine the roles of IDE, 510(k), and PMA submissions in the product development process. The learning objective is to understand the differences between the three major types of FDA permissions—IDEs, 510k, and PMAs—as a basis for understanding medical device regulations. Learn more -> Tuition: $500 for first learner; $195 for additional learners. Dates: Please check the calendar on CDG's home page for presentation dates. |
CD $550 OnDemand $500  Since first given responsibility to monitor the progress of their clinical trials by the regulations of 1974-76, monitoring has played a unique role in the relationship of sponsor and investigator. But it isn't magic. Monitoring is a set of skills that can be mastered by anyone with a sense of order and completeness. If you like things to be 'finished' you will make a good monitor. The learning objective is to be able to identify and implement the four types of monitoring visits in a clinical trial. Learn more -> Dates: Please check the calendar on CDG's home page for presentation dates. |
