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As one of the fastest growing industries, the market figure for medical devices is expected to exceed the $260 billion mark by the year 2007. Built into this growth is increased regulatory scrutiny, putting pressure on the industry to conform and perform.

SMi’s ‘Medial Devices’ will follow the global market with a particular focus on what the industry needs to accomplish 2007-8 with consideration on key challenges, limitations and regulatory implications to be faced. Leading market professionals will explore the current regulatory climate by addressing how current and emerging guidelines may affect the individual device manufacturer and vice versa. What are the necessary submission requirements? How can you gain regulatory approval for your medical device products smarter and faster?

Attend this industry specific forum to uncover the latest best practice advice on addressing your post-marketing surveillance and vigilance concerns in order to minimise risk and maximise safety. By participating in this event, you will learn how to approach your risk analysis, evaluation and adverse event reporting by key experts at the forefront of their industry who will ensure that you have the information required to conform with regulatory standards on an international level.

Key speakers scheduled to attend, include:

  • Dr Bernadette Alford, Vice President, Regulatory Affairs, Stryker Biotech 
  • Brad Hossack, Vice President, International Regulatory Affairs, Boston Scientific
  • Brian Kunst, Vice President, Regulatory Affairs & Quality Assurance, AngioDynamics 
  • Jeff Bush, Director, Corporate Reimbursement, Becton Dickinson (BD) 
  • Dr Joachim Wilke, Director, Regulatory, Quality & Clinical Affairs, Medtronic 
  • John Glaccum, Project Quality Director, Ethicon Endo-Surgery 
  • Dr Ekkehard Stösslein, Head, Active Medical Devices Department, BfArM 
  • Dr Andrea Sparti, Head, Vigilance Team, Medical Devices Division, Swissmedic 
  • Anne-Marie Li-Kwai-Cheung, Senior Regulatory Affairs Officer, Biosurgery, Genzyme 
  • Stephen Dibert, President & Chief Executive Officer, Medical Devices Canada (MEDEC) 
  • Robert Klepinksi, Attorney, Fredrikson & Byron 
  • Danielle Giroud, President & Chief Executive Officer, D-Target

Attend this industry specific forum to guarantee you hear international and expert perspectives on:

  • THE MEDICAL DEVICES MARKET: What does the medical device industry need to accomplish 2007-8? Which disease management areas are most likely to impact future opportunity, investment and growth potential? 
  • PRICING & REIMBURSEMENT: Hear from the experts as they discuss key industry challenges and strategic recommendations to overcome them, whilst exploring pricing and reimbursement in major European and US markets
  • REGULATORY IMPLICATIONS: What are the important regulatory changes and how will they affect individual device manufacturers?
  • CLINICAL EVALUTIONS: Hear discussion on the new environment for clinical evaluations and how best to overcome the gaps in current regulatory schemes for drugs and medical devices
  • ACHIEVING INTERNATIONAL COMPLIANCE: Learn how to meet the demands of the global market with best practice advice and programmes on how to comply on an international level
  • REGULATING QUALITY SYSTEM REQUIREMENTS: Understand how the international reference standard for medical devices affects you and your business. How much influence does QSR have on the product life span?
  • POST-MARKET SURVEILLANCE & RISK MANAGEMENT: Looking beyond medical device vigilance – how to monitor the activities of medical devices in use

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Bernadette Alford

Bernadette Alford, Vice President, Regulatory Affairs, Stryker Biotech

9:10 ASSESSING THE GLOBAL MARKET FOR MEDICAL DEVICES

Stephen Dibert

Stephen Dibert, President & Chief Executive Officer, MEDEC

  • Who are the key players within the medical device industry?
  • What does the medical device industry need to accomplish in 2007-8?
  • Uncovering potential partnership opportunities
  • Challenges, limitations and regulatory implications
  • Key areas of specific opportunity
  • Which disease management areas are most likely to impact future opportunity, investment and growth potential within the device area?
  • Exploring the drug/device interface
  • 9:50 OPENING NEW AVENUES FOR MEDICAL DEVICE MARKETS IN EASTERN EUROPE

    Kavitha Ravikumar

    Kavitha Ravikumar, Team Leader, Medical Devices, Frost & Sullivan

  • What is the result of standardisation and conformity levels on reform?
  • What opportunities are available in Eastern Europe?
  • What are the impacts - geographic environments, economic indicators, healthcare indices, medical device regulation and market features?
  • Assessing the regions suitable for your manufacturing base
  • Investment incentives - where does this fit in?
  • 10:30 Morning Coffee

    10:50 PRICING AND REIMBURSEMENT ISSUES RELATING TO THE MEDICAL DEVICE INDUSTRY

    Jeff Bush

    Jeff Bush, Director, Corporate Reimbursement, Becton Dickinson

  • Recent developments and their influence on the medical devices industry
  • Assessing reimbursement in major European markets – practical solutions
  • Co-ordination of US and EU clinical and price positioning strategies
  • The impact of large-scale purchasing among hospitals on medical device manufacturers – current challenges and implications for price
  • With financial reduction in procurement of new technologies, what is the impact on the development and innovation of the medical device industry?
  • Routes for successful reimbursement
  • 11:30 CURRENT REGULATORY CLIMATE – IMPACT ON THE INDUSTRY

    Bernadette Alford

    Bernadette Alford, Vice President, Regulatory Affairs, Stryker Biotech

  • Highlighting new changes in the medical device regulations
  • Key strategies for the medical device industry in the wake of enhanced regulatory scrutiny
  • Submission requirements – what documents are required for approval of medical device products?
  • Structuring your submissions and post-approval documents
  • Opportunities and challenges in regulating medical devices – FDA standpoint
  • What challenges will FDA face in 2007/8?
  • Important regulatory changes affecting electromedical device and equipment manufacturers
  • How can medical device manufacturers impact the regulatory process?
  • 12:10 REVISING THE MEDICAL DEVICE DIRECTIVES

    Elisabethann Wright

    Elisabethann Wright, Counsel, Hogan & Hartson LLP

  • What regulations govern the conduct of medical devices? How do you choose a notified body?
  • Improving requirements for safety for the patients whilst continuing to provide a coherent legislative framework that fosters competitiveness
  • Addressing conformity assessment including issues of design documentation and design review
  • Clarification of clinical evaluation requirements
  • Opportunities for post-marketing surveillance
  • Ensuring compliance of custom made device manufacture
  • How will these amendments support better implementation?
  • When will they be adopted and what will be the likely impact on the industry?
  • Managing inconsistencies between FDA, the EU directive and ICH guidelines – how best to comply?
  • 12:50 Networking Lunch

    14:20 THE GLOBAL HARMONISATION TASK FORCE (GHTF)

    Brian Kunst

    Brian Kunst, Vice President, Regulatory Affairs & Quality Assurance, AngioDynamics

  • Introducing the work of the Global Harmonisation Task Force
  • Encouraging convergence in regulatory practices – the challenges
  • Harmonising approaches to ensure safety, effectiveness/performance and quality of medical devices
  • How are guidance documents adopted/implemented by member regulatory authorities
  • Working towards harmonisation in medical device regulation – current activities
  • Designing for patient safety in a global regulatory model
  • Current focus of GHTF study groups
  • How can new member states use this information to devise their own regulatory guidelines and programmes
  • 15:00 CLINICAL EVALUATION

    Danielle Giroud

    Danielle Giroud, Chief Executive Officer, D-Target

  • What is the impact of the changing regulations and guidelines for clinical data and evaluations?
  • Obtaining clinical data – how to collate the necessary information
  • The clinical evaluation – what is involved and how should this be conducted?
  • The clinical investigation – what is involved and how should this be conducted?
  • Pitfalls to avoid
  • Preparing data for global market access
  • The clinical evaluation for combination products
  • 15:40 Afternoon Tea

    16:00 ADDRESSING GAPS IN THE CURRENT REGULATORY SCHEME FOR DRUGS AND MEDICAL DEVICES

    Anne-Marie Li-Kwai-Cheung

    Anne-Marie Li-Kwai-Cheung, Senior Regulatory Affairs Officer, Biosurgery, Genzyme

  • How to design a clinical development plan for a drug/device combination production?
  • Deciding on the principal mechanism of action by which the claimed effect or purpose is achieved - related regulatory guidelines
  • Challenges and limitations in relation to drug/device products
  • Guidelines and labelling for combination products
  • Devising an appropriate regulatory framework for new and emerging therapeutic products that are difficult to define under current frameworks, including combination products
  • Post-market surveillance for combination products
  • 16:40 REGULATING QUALITY SYSTEM REQUIREMENTS (QSR)

    John Glaccum

    John Glaccum, Project Quality Director, Ethicon Endo-Surgery Inc

  • Approach to integrating QSR, ISO13485:2003, and ISO9000:2000 requirements.
  • Preparing for QSR audits and inspections
  • Management review integration and preparation
  • How important is it to comply with the quality systems – what impact does this have on regulatory compliance?
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Brad Hossack

    Brad Hossack, Vice President, International Regulatory Affairs, Boston Scientific Corp.

    9:10 ACHIEVING INTERNATIONAL COMPLIANCE

    Brad Hossack

    Brad Hossack, Vice President, International Regulatory Affairs, Boston Scientific Corp.

  • Summarising the medical device regulatory requirements outside of the US and Europe
  • How can you comply on an international level?
  • Best practice advice and solutions
  • 9:50 LABELLING FOR MEDICAL DEVICES – COMPLIANCE STRATEGIES

    Caroline Freeman

    Caroline Freeman, Senior Consultant, Quintiles

  • What content should be made available?
  • Consideration on the use of language and symbols
  • Cost implications and strategies to curtail them
  • Labelling for specific devices
  • Encouraging the development and use of international labelling guidelines
  • The FDA’s current view on international symbols
  • To e-label or not to e-label – follow the argument for the use of electronic labelling
  • 10:30 Morning Coffee

    11:00 CONDUCTING RISK ANALYSIS

    Haroon Atchia

    Haroon Atchia, Chief Executive Officer & Technical Director, Quality First International Limited

  • Assessing risk analysis based on experience, evidence and computation
  • Understanding the expectations of FDA and the EU in applying risk analysis to medical devices
  • Understanding the application of risk analysis methodologies such as FMEA and FTA to medical devices
  • The International Organisation for Standardisation (ISO) 14971 and its framework for manufacturers – best practice advice for risk analysis, evaluation and risk control for risk management in medical device design development and manufacture
  • How should you monitor the safety and performance of the device after sale?
  • Common pitfalls inherent with many risk management programmes
  • 11:40 SAFETY AS A RISK MANAGEMENT ISSUE

    Joachim Wilke

    Joachim Wilke, Director, Regulatory/Quality & Clinical Affairs, Medtronic

  • Ensuring co-operation between those involved in the medical device and its product lifespan
  • What is your role? Recognising, the responsibility of the manufacturer, importer/vendor, government, user and public
  • Developing and employing a risk management strategy
  • How to employ risk management when developing features for safety and profitability? How to employ risk management for efficient design transfer?
  • Linking safety to device effectiveness/performance
  • Considering risk throughout the product life-cycle
  • What to expect from the FDA and worldwide regulatory bodies with regard to managing patient risk
  • 12:20 Networking Lunch

    13:50 POST-MARKET SURVEILLANCE AND VIGILANCE

    Andrea Sparti

    Andrea Sparti, Head, Vigilance Team, Swissmedic

  • What does the directive and MEDDEV state for vigilance?
  • Understanding the EU medical device vigilance system
  • The revision of MEDDEV
  • The revision of the directives
  • Post-market clinical follow-up
  • EUDAMED - the European Database on Medical Devices
  • 14:30 EXPLORING VIGILANCE SYSTEMS

    Ekkehard Stosslein

    Ekkehard Stosslein, Head, Active Medical Devices Department, Federal Institute For Drugs And Medical Devices (Bfar M)

  • Implication of the federal structure
  • Structure of the department Medical Devices
  • (Internal) Assessment criteria
  • Some statistics
  • Recommendations to industry
  • 15:10 Afternoon Tea

    15:40 PANEL DISCUSSION

  • Unifying different national standards and regulatory practices – challenges and limitations
  • How can we minimise regulatory barriers?
  • How can we facilitate trade whilst improving access to new technologies?
  • Bernadette Alford

    Bernadette Alford, Vice President, Regulatory Affairs, Stryker Biotech

    Elisabethann Wright

    Elisabethann Wright, Counsel, Hogan & Hartson LLP

    Joachim Wilke

    Joachim Wilke, Director, Regulatory/Quality & Clinical Affairs, Medtronic

    16:20 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Conducting Clinical Investigations with Medical Devices in Europe
    Workshop

    Conducting Clinical Investigations with Medical Devices in Europe

    The Hatton, at etc. venues
    25th October 2006
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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