Medical Devices

First Announcement
HAC20 HYDROXY-APATITE CERAMIC
Future Perspectives and 20 Years' Experience
A Symposium will be held on 29th and 30th September at the Royal College of Surgeons in London to celebrate the 20th Anniversary of the first clinical use of hydroxy-apatite ceramic in orthopaedics.
A distinguished international faculty will be presenting both new advances in biomaterials and the long-term follow-up of hydroxy-apatite coated orthopaedic implants. Full programme will be available in February 2005
Visit the HAC20 website
For further information please contact Andrea James at Management Forum
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EC MEDICAL DEVICE VIGILANCE AND POST-MARKET SURVEILLANCE SYSTEM
7/8 February
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This conference provides a unique opportunity to meet Competent Authorities, consultants and manufacturers to understand and discuss the regulatory requirements with respect to vigilance.
Conference No N2-8405
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AN INTRODUCTION TO THE MEDICAL DEVICES DIRECTIVES
11 February
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Directives for both Active Implantable Medical Devices, Medical Devices and In-Vitro Diagnostic Medical Device Directives are now in force. This seminar provides a basic introduction to the European medical device legislation. It will explain the directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. In addition, it will also cover the documentation necessary to apply the CE mark and review the changes currently under-way as part of the 5 year review. This is an excellent introduction from leading experts in the field.
Conference No N2-8105
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Discounted rate available if both conference and workshop are booked together
NEEDLE-FREE AND AUTO INJECTORS
28 Feb/1 March
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This is the tenth conference in an annual series where those involved in the field come together to share new thinking and to discuss new technical developments. We shall cover topics such as the changing requirements for needle-free technology, regulatory considerations for combination products, quality engineering, handling difficult injectables and mechanics of jet injection, as well as reviewing newly designed devices.
Conference No N2-8005
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COMBINATION PRODUCTS
2 March
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This workshop will provide strategies for determining, influencing and negotiating the best regulatory path and provide participants with the opportunity to apply these strategies to real life case studies. The session will also cover managing post-marketing requirements including practical approaches to Quality System/GMP Compliance. Additionally, some practical considerations on working with strategic partners and developing successful project plans will be addressed.
Conference No N3-8305
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NICE & THE PHARMACEUTICAL INDUSTRY
In association with the National Institute for Clinical Excellence
17 March
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The National Institute of Clinical Excellence (NICE) was set up in 1999 as a Special Health Authority, with the objective of improving the quality of care NHS professionals provide their patients. Because NICE is required to consider both clinical issues as well as cost effectiveness, in formulating its advice, its role and guidance is sometimes controversial. This meeting will bring together experts from NICE itself, as well as Industry representatives, to assess the importance of the Institute and clarify its current and future roles. This includes the implications of NICE taking on the functions of the Health Development Agency The appraisal process and clinical guidelines process will both be discussed, as well as the key issue of the implementation of NICE guidance.
Conference No A3-4005
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CONDUCTING PRE- AND POST-MARKET MEDICAL DEVICE CLINICAL STUDIES
17/18 March
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This course has been designed specifically for those involved in pre and post market studies within the medical device industry. The device development process can be complex, costly and can take years to complete. The collection of clinical data to demonstrate safety and performance of a device is pivotal to the development process and necessary for regulatory approval. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market. This course will cover the full range of clinical research activities that should be applied during the collection of data for both pre and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe. Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe. There will be ample time for case studies and group discussions.
Conference No N3-8105
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FDA APPROVAL PROCESS FOR MEDICAL DEVICES
5/6 April
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This seminar will highlight new changes to the medical device regulations and provide an overview to the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information and obtain product approval.
Conference No N4-8405
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NASAL DRUG DELIVERY 
7/8 April
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Activity in the field of nasal drug formulation and delivery systems development continues to increase. Many of the top tier pharmaceutical companies are developing a variety of products for both systemic and topical delivery. Just how difficult it is to bring a product to market and where is the principal activity outside of topical drugs? What are the FDA requirements for biologics ad vaccines? Just how real is nose to brain transport in man and what can animal models tell us? This conference seeks to explore these and many other questions within the field of nasal drug delivery and will include a focused session and debate on ‘Nose to Brain Transport’. Leading authorities in the field and associated technologies will cover aspects of physiology, formulation, the effects of particle size, nose to brain in man and the area of legislation of nasal products. In addition, case histories of existing/in development products/delivery systems will be explored.
Conference No N4-8005
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EU REIMBURSEMENT FOR MEDICAL DEVICES
13 April
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This seminar will provide practical solutions to obtaining reimbursement in Europe for medical devices and will particularly focus on the following countries; Germany, France and the UK. It will assess the growing role of Healthcare Technology Assessment (HTA) and the impact of Diagnostic Related Groups (DRGs) on the medical device industry. Comparisons will be made between different systems and there will be plenty of opportunity to discuss various routes for successful reimbursement.
Conference No N4-8105
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ACHIEVING REIMBURSEMENT FOR MEDICAL DEVICES IN THE US
14 April
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This one day seminar will provide the essential information for US product launch; including an overview of the US Healthcare System decision makers, practical steps to ensure optimal technology coverage, proper coding and reimbursement policies, and strategies for product positioning under the myriad of US Reimbursement Systems.The objective of this seminar is to provide step-by-step information to develop a product roll-out strategy that will minimise time to product adoption and maximise market penetration. The focus of the seminar will be on real-life situations, case studies and group discussion about reimbursement.
Conference No N4-8205
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QUALITY MANAGEMENT FOR MEDICAL DEVICES
26/27 April
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This two day practical workshop will provide an in depth look at the QMS standards underpinning medical device regulatory compliance in relation to the global medical device regulatory regime. There will be special emphasis on compliance with one or more of the ‘NEW APPROACH’ European Directives for Medical Devices 90/385/EEC, 93/42/EEC & 98/79/EC.The course will also provide comprehensive coverage of the background to, interpretation and practical implementation of the full ISO 9000:2000 family of standards. It then builds to incorporate the specific requirements of the medical device QMS standard EN ISO 13485:2003 and most significantly the guidance from ISO TR 14969:2004.The course format will include interactive workshops and case studies.
Conference No N4-8305
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If you have any other topics in this area which you feel we should be covering
please contact Andrea James

Or Tel: +44(0)1483 570099