Hear keynote presentations from the experts - amdr.org · Day One – 21st May, 2012: International...

3 E V E N T S I N O N E :

- M e d i c a l D e v i c e s P a y e r s ’ Pe r s p e c t i v e s

- M a r k e t A c c e s s f o r M e d i c a l D e v i c e s i n E s t a b l i s h e d M a r k e t s

- M a r k e t A c c e s s f o r M e d i c a l D e v i c e s i n E m e r g i n g M a r k e t s

H e a r k e y n o t e p r e s e n t a t i o n s f r o m t h e e x p e r t s : Brian Griffin, C E O, M e d c o I n t e r n a t i o n a l , U S A

Dr. Geoff Wilson, H e a d o f H e a l t h E c o n o m i c s & R e i m b u r s e m e n t E M E A , G E H e a l t h c a r e , U K

Sally Chisholm, C E O, N a t i o n a l Te c h n o l o g y C e n t r e , N H S , U K

Dr. Gabriela Soskuty, V i c e P r e s i d e n t , G o v e r n m e n t A f f a i r s , H e a l t h Po l i c y a n d E c o n o m i c s , B . B r a u n M e l s u n g e n AG , G e r m a n y

Dr. Stephen Stefani, P r e s i d e n t , I S P O R , C h a i r o f H e a l t h C a r e Po l i c y m a k e r s & P a y e r s C o m m i t t e e , I S P O R L a t i n A m e r i c a C o n s o r t i u m , C o o r d i n a t o r o f t h e O n c o l o g y U n i t , U N I M E D, B r a z i l

M a r k e t a n d P a t i e n t A c c e s s C h a l l e n g e s f o r M e d i c a l Te c h n o l o g y M a n u f a c t u r e r s w h i l s t C o n t a i n i n g C o s t s a n d M a x i m i s i n g H e a l t h O u t c o m e s .

f o r M ll

& more than 35 expert medicaldevice speakers

Day One – 21st May, 2012: International Medical Device Payer & HTA Forum Policy challenges to contain costs and maximise health outcomes

Global healthcare systems are evolving daily. At a time of increased health economic reform, leaders in medical technology look to achieve optimal market access and commercialization of their products. As patients and payers worldwide demand more value for money, the importance of achieving market access in a cost effective manner is of the utmost importance. With payers in both developed and developing countries under extreme budgetary pressure, we will provide a platform for attendees to examine how health technologies are assessed, tough decisions are made and how we define “value”. This exclusive forum is the opportunity to meet and network with a broad spectrum of senior representatives who wish to encourage innovation whilst managing a limited budget.

Day Two – 22nd May, 2012: Medical Device Market Access Strategies in Advanced Markets Challenges to access for medical technology manufacturers in leading markets

In the developed markets, significant changes to the regulatory processes for bringing medical devices to market are being considered. With budget pressures forcing companies to be innovative and efficient, medical device manufacturers must adhere to best practices in planning, development and manufacturing of next generation health technologies in order to attain market access. Demonstrating value to HTA agencies and payers has never been more important to medical device manufacturers and in Berlin we will present strategies for creating compliant medical devices and bringing products to market faster. Uniquely this event will be the only medical device meeting looking at the specific requirements in 3 main product areas; surgical devices & implants, imaging & capital equipment and in-vitro diagnostics.

Day Three – 23rd May, 2012: Medical Device Market Access Strategies in Emerging Markets Meeting the needs of payers to achieve emerging market access in the MedTech Arena

Health technology device companies are increasingly turning to emerging markets to accelerate growth. Budget cuts, ageing populations and an emerging middle class have resulted in opportunities and challenges for medical device manufacturers entering emerging markets. The primary risks and challenges vary from market to market and present a complex playing field for medical device companies. Companies that lack a well-planned emerging market chain strategy are at risk of ending up with limited growth and profitability. Manufacturers with extensive emerging market experience will present case-study examples of successful market-penetration strategies and explore the real potential for further growth.

Who Will Benefit:Device manufacturers & distributors: Marketing, Market-access, Business Development, Country Managers, Health Economics, Pricing & Reimbursement, Government & Stakeholder Relations, Regulatory Affairs

StakeholdersHealth Plans & Insurers, Payers, Health Technology Assessors, Hospitals, Health Ministry, Regulatory Agencies, Independent Health Economists, Academics, Physicians and Patient Groups

Solution providers & consultants CEOs, Business Development, Senior Consultants, Global and Regional Heads, Independent Academics, Health Economists, Public & Private Healthcare Providers, Senior Doctors & Patient Representatives

PAGE ONE

DAY 1

AM

DAY 2 DAY3

International Medical Device Payers & HTA Forum

Market Access Strategies in Established Markets

Market Access Strategies in Emerging Markets

PM

STREAM 1 STREAM 2 STREAM 3

Surgical Devices, Interventions & Implants

Imaging & Capital Equipment

In- Vitro Diagnostics

Event Structure:

EventOver v iew

PayersJohn GraylandSenior Strategy and Redesign Manager, Long Term ConditionsNHS, UK

Brian Griffin, CEOMedco International, USA

Gottfried EndelManaging DirectorThe Main Association of Austrian Social Security (HVB), Austria

Olaf KoesterDirector, Drug Plan Management Policy UnitManitoba Health, Canada

Heinzpeter MoeckeMedical DirectorAsklepios, Germany

Paula PolmanCoordinator, Dutch Health Care Insurance Board (CVZ)Netherlands

Ad SchurmanHead of Business Contact Centre and International AffairsCVZ, Netherlands

HTAsProfessor Stefano CapriHeadHTA committee of the Lombardy Region, Italy

Professor Barry CooksonDirectorHealth Protection Agency, UK

Jeffrey C. Lerner, Ph.D.,President & Chief Executive OfficerECRI Institute, USA

Lorenzo TerranovaDirectorThe Italian Federation of Public Health Enterprises and Hospitals (FIASO), Italy

Martin VisnanskyCo-founderSLOVAHTA, Slovakia

IndustryMartin BraeckleinHead of technical consortium: Partnership for the HeartRobert Bosch Healthcare GmbH, Germany

Robert DownesMember of the BoardGetemed, Germany

Dr. Arne C. FaisstCEO Mathys Ltd Bettlach, Germany

Hans FreriksDirector Quality & Regulatory AffairsPhilips, Netherlands

William GartnerCEOProvista Life Sciences, USA

Heinz GerhardsCEOMedicor Imaging, USA

Mike KarimDirector of Europe & Developing MarketsHeartware Inc., UK

Dr. Geoff WilsonHead of Health Economics & Reimbursement EMEAGE Healthcare, UK

Syed RashidDirector of Health Economics & Reimbursement, EMEAKCI Medical, UK

John RidgeDirector, Global Reimbursement and Healthcare EconomicsVentana, Roche Group, USA

Dr. Gabriela SoskutyVice President, Government Affairs, Health Policy and EconomicsB. Braun Melsungen AG, Germany

Andrea ZanellaCountry General Manager – Italy/GreeceBecton Dickinson, Italy

Payers & HTAsSally ChisholmCEONational Technology Adoption Centre, NHSUK

Dr. Iñaki Gutiérrez-IbarluzeaKnowledge ManagerOsteba, The Basque Office of HTA

Prof. Thomas PenzelHead of Sleep CentreCharite, Germany

Professor Terry YoungProgramme Director, Chair of Healthcare SystemsMATCH, UK

Academics & Solution Providers

Csaba DozsaAssociate ProfessorThe Corvinus University of Budapest, Hungary

IndustryLuis FonsecaBusiness Director CRDM Latin AmericaMedtronic, Brazil

Mustafa KaramizrakGeneral ManagerSynthes, Turkey

Carol Jirui YanSenior Director Regulatory Affairs & StrategyJohnson & Johnson Medical Asia Pacific, China

Payers

Dr. Filiz CevirmeGeneral DirectorPrivate Hospitals and Healthcare Organisations Association (OHSAD), Turkey

Juozas GaldikasDirectorState Health Care Accreditation Agency, Lithuania

Guillermo MelendezScientific CoordinatorMexican Health FoundationMexico

Dr. Stephen StefaniPresident, ISPORChair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil

Sinisa TomicHead of Agency of Medicinal Products & Medical Devices, Croatia

PAGE TWO

SpeakerPanel

Day 1 Day 2 Day 3Payers & HTA Forum Advanced Markets Emerging Markets

AN OVERVIEW OF PATIENT ACCESS TO MEDICAL TECHNOLOGIES

09:10 A payer’s perspective: The hurdles and opportunities in key markets

❖ What can be done to lead healthcare systems onto a more sustainable path? ❖ Assessing costing and health economics analysis within the health technology

arena. ❖ Assessing the impact of changing public expectations, socio-demo graphic

changes, disease patterns and advancements in scientific knowledge have on the medical device sector.

Brian Griffin, CEO, Medco International, USA

THE EVOLVING ROLE OF HTAs IN THE PROVISION OF ACCESS TO INNOVATIVE HEALTHCARE

09.45 What is the current state of play with HTA across Europe?

❖ HTA defined. ❖ Current status for HTA in Europe specifically for medical devices and diagnostics. ❖ Current issues with HTAs and some (possible) solutions. ❖ Beyond HTA: Communicating value.

Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEAGE Healthcare, UK

10.20 Health technology forecasting and the assessment of innovative health technologies

❖ Horizon scanning and health technologies. ❖ Innovative technology assessment. ❖ Medical device evaluation.

Jeffrey C. Lerner, Ph.D., President & Chief Executive Officer, ECRI Institute, USA

10.55 Networking & Coffee Session

11.20 Investigating best practice methods for the future of patient engagement in HTA

❖ How to get the most out of patient participation in the HTA process? ❖ Evidence based outcomes and the utilization of patient databases.

Gottfried Endel, Managing DirectorThe Main Association of Austrian Social Security (HVB), Austria

EXPERIENCES WITH RISK-SHARING & ALTERNATIVE PRICING SCHEMES

11.55 Case Study: An experience with implementing flexible outcome-based schemes to minimise risk

❖ What schemes exist for medical devices? ❖ Utilisation management agreements. ❖ Can difficulties in implementing & administering schemes be overcome?

Olaf Koester, Director, Drug Plan Management Policy UnitManitoba Health, Canada

12.30 Medical devices: Assessment for reimbursement

Outpatient ❖ List of product categories. ❖ Assessment by CVZ

Paula PolmanCoordinator at Dutch Health Care Insurance Board (CVZ)

Hospital ❖ Assessment expensive medicinal products: therapeutic value and cost

effectiveness. ❖ Innovative products.

Ad Schurman, Head of Business Contact Centre and International AffairsCVZ, Netherlands

13.05 Luncheon Break

COMMUNICATING CRITERIA FOR PRIORITSING AND JUSTIFYING CAPITAL EXPENDITURES WITH LIMITED

BUDGET14:10 MRSA screening and the factors that need to be considered regarding introducing new technology

❖ Valuing the indirect cost savings from advanced medical devices: Simplifying surgery, minimizing hospital stays, recovery time and achieving patient satisfaction

❖ Managing short-term budget impact vs. long term investment/reimbursement ❖ How to demonstrate the cost-effectiveness of a medical technology over a drug

intervention ❖ Managing the trade-off with medical devices in the short-term – high cost

outcome vs long term outcomes from drug therapy

Barry Cookson, Director, Health Protection Agency, UK

14.45 Integrating evidence into the pricing and reimbursement decision making process for medical devices

❖ Description of agency’s responsibilities and co-operations with regional and country-wide health authorities.

❖ Format for health technology rapid assessment and comparative effectiveness. ❖ Examples of medical technologies that have effectively integrated evidence into

the pricing & reimbursement decision making process.

Professor Stefano Capri, Head, HTA committee of the Lombardy Region, Italy

15.20 Dealing with an increased demand for HTA in medical devices

❖ An examination of “The Exploratory Process” started by the European Commission

Martin Visnansky, Co-founder, SLOVAHTA, Slovakia


16.20 How to control the development of new health technology products; controlling and evaluating supply

❖ Establishing predetermined standards for medical devices ❖ Innovative formats for measuring performance

Lorenzo Terranova, DirectorThe Italian Federation of Public Health Enterprises and Hospitals (FIASO), Italy

16.55 Evaluating telehealth & telemonitoring schemes

❖ The commissioning of telehealth services for patients with long term conditions ❖ Methods of evaluating the cost effectiveness of each scheme ❖ Why there is a strong case for future investment in telemonitoring schemes?

John Grayland, Senior Strategy and Redesign Manager, Long Term Conditions, NHS, UK

17:30 Panel Discussion: An evaluation of health economic evaluations in different countries

❖ What are the large differences in payer expectations? ❖ How do we face the current methodological challenges when dealing with high

tech requirements? ❖ What are the pitfalls of health economic evaluations? How have some messages

failed in the past?

Brian Griffin, CEO, Medco International, USAHeinzpeter Moecke, Medical Director, Asklepios, GermanyDr. Geoff Wilson, Head of Health Economics & Reimbursement EMEA, GE Healthcare, UK

17.55 Chairperson’s closing remarks

18.00 End of day

21st May, 2012

International Medical Device Payer & HTA Forum

Policy challenges to contain costs and maximise health outcomes

DAY 1

19:30 - Exclusive Complimentary Networking Dinner for all event participantsPAGE THREE

Medical Device Market Access Strategies in Advanced Markets

Challenges to access for medical technology manufacturers in leading markets

OVERVIEW OF HEALTHCARE SYSTEMS AND REFORM INITIATIVES IN ADVANCED MARKETS

09.00 Market access hurdles and opportunities in key markets

❖ Trends of economics and market access for medical devices. ❖ Implementation of the latest EU directives.

Professor Terry Young, Programme Director, Chair of Healthcare SystemsMATCH, UK

MARKET ACCESS DRIVERS & MODELS

09.35 How states are moving ahead to translate HTA into new medical policies

❖ Establishing mechanisms for translating HTA results more actively. ❖ Recommendations that guide public and private insurers. ❖ International review of key healthcare reforms. ❖ The evolving role of post licensing appraisal within the medtech sector

Csaba Dozsa, Associate Professor, The Corvinus University of Budapest, Hungary

10.10 Managing complex pricing strategies across various markets

❖ How we define “value” across borders? ❖ Understanding the issues arising from differing pricing approaches ❖ How to maximise sales in fluctuating markets?

Andrea Zanella, Country General Manager – Italy/GreeceBecton Dickinson, Italy


11.10 An industry perspective on 510(k) and CE Marking

❖ Anticipated changes in laws governing medical devices. ❖ Similarities and differences between the regulatory procedures

governing medical devices in the US and EU. ❖ What to do after receiving a warning letter? Prompt and convincing

replies.

Dr. Iñaki Gutiérrez-Ibarluzea, Knowledge Manager, Osteba, The Basque Office of HTA

11.45 Sleep medicine – an expanding opportunity

❖ An analysis of market access strategies in new medical devices

Prof. Thomas Penzel, Head of Sleep Centre, Charite, Germany


INNOVATIVE VALUE DEMONSTRATION TECHNIQUES

13.20 Case Study: How medical device manufacturers can achieve success in a new era of healthcare delivery

❖ Working with transactional databases. ❖ How payers use real-world data to make decisions. ❖ Risk management – Integration, simplicity & efficiency.

Dr. Gabriela Soskuty, Vice President, Government Affairs, Health Policy and Economics, B. Braun Melsungen AG, Germany

13.50 McKinsey & Company Case Study

An analysis of innovative value demonstration techniques

14.20 Adopting innovation in the NHS – the critical issues

❖ Understanding the NHS requirement for successful submission ❖ How the NHS measures the impact of new technologies? ❖ Shortening the implementation timelines once a product is launched and

tips to gaining buy-in from all key stakeholders

Sally Chisholm, CEO, National Technology Adoption Centre, NHS, UK



DAY 222nd May, 2012

Choose your afternoon stream for our product-specific focused case-study sessions:

STREAM 1Surgical Devices, Interventions & ImplantsSTREAM 2


STREAM 3

In-vitro Diagnostics

PAGE FOUR19:30 - Exclusive Complimentary Networking Dinner for all event participants

STREAM 1Surgical Devices, Interventions & Implants15.20

Achieving market access through certifications: An introduction to CE Marking for surgical devices

Syed RashidDirector of Health Economics & Reimbursement, EMEA, KCI Medical, UK

15.55

Commercial return on surgical devices & implants: Strategies and tactics for market access

Mike KarimDirector of Europe & Developing MarketsHeartware Inc., UK

16.30 Networking & Coffee Break

16.55

Strategies to increase exports and expand patient access to your medical device

Dr. Arne C. Faisst, CEO Mathys Ltd Bettlach, Germany

17.30 Panel Discussion

Choosing a business model which shows an ROI for payers

• Achieving greater penetration into hospital and clinical settings.

• Ethical training and retention practices of surgeons and KOLs.

Dr. Gabriela Soskuty, B. BraunDr. Arne C. Faisst, Mathys Ltd BettlachMike Karim, Heartware Inc.Syed Rashid, KCI Medical

18.00 End of day

STREAM 2Imaging & Capital Equipment

15.20

Building an effective design and process validation program for capital equipment in order to successfully achieve market access

Heinz GerhardsCEOMedicor Imaging, USA

15.55

New models of evidence generation for payers & regulators

Martin BraeckleinHead of technical consortium Partnership for the Heart; Business Development Bosch HealthcareRobert Bosch Healthcare GmbH, Germany


16.55

Boost confidence in the quality of your device through product tests and certifications

Hans Freriks, Director Quality & Regulatory AffairsPhilips, Netherlands


Methods of engagement with doctors & practitioners

• Demonstrating the increased value of innovations in imaging devices.

• Where can the industry better work with the tendering process?

• Future business models for capital equipment manufacturers (e.g. hospital partnerships).

Dr. Geoff Wilson, GE HealthcareMartin Braecklein, Bosch HealthcareHans Freriks, PhilipsHeinz Gerhards, Medicor Imaging

18.00 End of day

STREAM 3In-vitro Diagnosticsfor

15.20

Developing global market access strategies for diagnostics

John RidgeDirector, Global Reimbursement and Healthcare Economics, Ventana, Roche Group, USA

15.55

Tackling the increasing international challenges in compliance for IVD products and how this impacts market entry

William GartnerCEOProvista Life Sciences, USA


16.55

Learn best practices of protocol and report writing – Target Groups, ECG Technology, Analysis tools, Telemonitoring & Data transmission

Robert DownesMember of the BoardGetemed, Germany


Marketing & commercial models for diagnostics

• What do manufacturers need to know when submitting marketing authorisations for CDx products?

Andrea Zanella, BDRobert Downes, GetemedWilliam Gartner, ProvistaJohn Ridge, Ventana

18.00 End of day

PAGE FIVE

DAY 222nd May, 2012

Medical Device Market Access Strategies in Advanced Markets

Challenges to access for medical technology manufacturers in leading markets

PAGE SIX

NEW MARKET STRATEGIES: HURDLES WITHIN THE HEALTH TECHNOLOGY INDUSTRY

09.10 An evaluation of health economic evaluations in different countries

❖ How important is emerging market growth for medical device companies?

❖ What countries and regions are the highest priorities? ❖ The current theory? Drugs first then devices. ❖ The emerging middle class in high growth markets. ❖ What innovative products do developing nations really need when budgets are

limited? “Rolls Royce” treatment or a “Hyundai”?

Dr. Stephen Stefani, President, ISPORChair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil

09.50 Case Study: Hospitals and healthcare organisations in Turkey

❖ The market by numbers. ❖ Hospital products – how to understand the needs of local decision makers

(hospitals).

Dr. Filiz Cevirme, General DirectorOHSAD, Turkey

10.30 Panel Discussion: The main obstacles in launching a medical device in an emerging market and achieving commercial access

❖ Slow registration processes and domestic specific protocols. ❖ The increasing investment of domestic companies. ❖ The struggle to keep pace with increasing health care access outside of major

cities. ❖ The challenge of local distributors and agents.

Stephen Stefani, Professor, ISPOR, BrazilDr. Filiz Cevirme, General Director, OHSAD, Turkey


FUTURE AND GLOBAL CHALLENGES TO REGULATORY COMPLIANCE

11.30 Regulatory & Reimbursement Uncertainty

❖ Overcoming inefficient regulation and registration processes. ❖ Complex tendering processes. ❖ The challenge of pricing controls. ❖ Working with local suppliers in order to influence panel experts

Juozas Galdikas, Director, State Health Care Accreditation Agency, Lithuania

12.10 Medical device regulation in an EU candidate country - adjusting market access strategies in times of on-going reform and health system modernization?

❖ What evolving healthcare reform means for health technology manufacturers looking to enter new markets?

❖ What type of device is the priority within limited budgets?

Sinisa Tomic, Head of Agency of Medicinal Products & Medical Devices, Croatia


14.20 The new emerging global regulatory environment – An Asian Pacific perspective on its internal and external markets

❖ Determining your regulatory path. ❖ Plan B – Having a contingency plan for unexpected problems and changes. ❖ An analysis of the evolving regulatory environment.

Carol Jirui Yan, Senior Director Regulatory Affairs & Strategy, Johnson & Johnson Medical Asia Pacific, China

CHALLENGES FOR MANUFACTURERS IN GAINING MARKET ACCESS

14.55 Case Study: Achieving market access for medical devices in Turkey

❖ Acquiring a distributor or starting up a fresh company? ❖ Turkish medical device market outlook: An overview of companies, growth

potential and macroeconomics of the country. ❖ The development of Turkish health systems and the 5 year outlook. ❖ Reimbursement models, the pilot project on establishing DRG system.

Mustafa Karamizrak, General Manager, Synthes, Turkey


16.00 The learning points for the industry: An example of a recently launched product

❖ Overcoming hurdles to launching products on an emerging market. ❖ Procedures in evaluating medical devices & diagnostics – defining “value”.

Luis Fonseca, Business Director CRDM Latin America, Medtronic, Brazil

16.40 Case study: Medical devices HTA and approval in Latin America

Guillermo Melendez, Scientific CoordinatorMexican Health Foundation, Mexico

17.20 Panel Discussion: Bringing your innovative device to the market – What you need to know?

❖ How to leverage data and information from submissions? ❖ How can medical manufacturers improve communication with government? ❖ What are the strategies that should be followed to develop a sustainable

regulatory framework that ensures safety and promotes innovation?


Guillermo Melendez, Scientific CoordinatorMexican Health Foundation, Mexico


18.00 End of day

Market Access Strategies in Emerging Markets Meeting the needs of payers to achieve emerging market access in the MedTech Arena

DAY 323rd May, 2012

PAGE SEVEN

EventPar tner s & Networ k ing

Are you interested in presenting your company products and services to this senior-level audience? If so please contact: [email protected]

Our team will be happy to tailor a package to suit your needs and get you the optimal level of exposure!

Thanks to our event partners:

NetworkingThe Medical Devices Leaders Forum will provide all delegates the chance to meet one another through our many networking opportunities. With pre-event, mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants. This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.

Media Partners

Event Partners

Professor Stefano Capri, Institute of Economics, Cattaneo – LIUC University, Member of HTA committee of the Lombardy Region, Italy

Prof. Stefano Capri is Senior Research Fellow on Health Economics at Cattaneo University-LIUC, Castellanza (VA), Institute of Economics. He holds a position of Adjunct Professor of Economics and Industrial Economics. He has been involved for many years in economic analysis of health care systems and economic evaluations of health care programmes and technology assessment for pharmaceutical companies and Public Authorities (Ministry of Health, Ministry of Economy, Regional Health Authorities). He was educated at Bocconi University, Milan, in Economic and Social Disciplines, and at University of York, UK (Health Economics). He has been recently appointed as member of the HTA Board (Health Technology Assessment) of the Lombardy Health Authority. Stefano Capri is author of about 100 scientific publications and 8 books. He has a specific interest in and publishes on drug pricing and risk sharing agreements, and on HTA methods and studies. He also worked on developing the Italian guidelines for economic evaluations as recommended by the Italian Group of Pharmacoeconomic Studies and by AIES (Italian Association of Health Economics).

Sally Chisholm, CEO, National Technology Adoption Centre, NHS, UK

Sally began her NHS career working in diagnostic radiography both within acute care and then in Cambridge and Manchester Universities Imaging Research Departments. An Information Technology degree led to a return to the NHS in information and IT services, including work with primary care to support GP Fundholding & Commissioning. In 2010 Sally was awarded an MBA (Open).Sally held a number of commissioning roles including joint posts with social care before spending two years working in Children’s Services at Manchester City Council. Four years as Director of the Cardiac and Stroke Network in Lancashire and Cumbria exposed her to cross organisational collaboration, service re-design and a focus upon delivering innovation and improving quality. Sally became Chief Executive of the NHS Technology Adoption Centre in May 2010.

Professor Barry Cookson, Director, Health Protection Agency, UK

Professor Cookson has been director of the Laboratory of Healthcare Associated Infection, Health Protection Agency, a WHO Nosocomial Infection Centre, since 1990 and holds visiting Professorships at the London School of Hygiene and Tropical Medicine and Imperial College, University of London. He is a specialist in Medical Microbiology, holds the Royal College of Physicians by examination (now a Fellow), is also dentally qualified and has been practising infection control for over 25 years. His research interests have comprised staphylococcal infection, neonatal pharmacokinetics, antimicrobial nephrotoxicity, microbial molecular epidemiology and typing systems, has been involved in several grant funded projects in the economics, surveillance and epidemiology of Healthcare Associated Infection and Antimicrobial resistance and the use of topical and light activated antimicrobials. He discovered mupirocin and triclosan resistance. He has over 180 peer reviewed publications and over 100 other publications including many books and chapters excluding abstracts and has served on the editorial board of several journals. Professor Cookson is also the medical microbiologist Advisor to the Veterinary Products Committee, a Care Quality Commission Associate and worked with them on reviews of HCAI and Long Term Care Facilities. He was a member of the DH Rapid Review Panel (for novel interventions for HCAI prevention and control) and an external expert to the Health Technology Assessment Panel for Diagnostic and Imaging Procedures, a WHO and ECDC consultant, an advisor for Global MRSA control guidelines and to the first Global Patient Safety Challenge (on hand hygiene) and chaired or been a member of several UK Standard and Guideline groups.

Robert Downes, Member of the Board, Getemed, Germany

Robert Downes, born 1963 in Dublin, Ireland, began his career with GETEMED Medizin - und Informationstechnik AG in 1987 as a hardware developer after completing his electrical engineering studies in Dublin. In 1996 he took over the responsibility of the product development department and joined the Board of Directors in April 2010. He also has a B.Sc.(Eng.), M.Sc.

Csaba Dozsa, Associate Professor, The Corvinus University of Budapest, Hungary

Csaba Dózsa was born on 27th May 1969 in Vác, Hungary. He obtained his degree in economics in 1994 at the Budapest University of Economic Sciences on the Faculty of Social Sciences with speciality on Social Policy and Planning.From 1997 to 1999 he was continuing postgraduate studies by the mean of a World Bank scholarship (Universidad de Barcelona y Pompeu Fabra, Barcelona) in the field of health economics and obtained a master degree in health economics (Máster en Economía de la Salud). He is an honorary associate professor at the Corvinus University of Budapest, currently he is taking part in the Doctoral Program of the Faculty of Economics.From 1994 to May 2005 he worked for the National Health Insurance Fund Administration, where he was the Deputy Director General for Health Policy and Health Care from June 2002. Then he worked for the Ministry of Health as the Deputy Secretary of State for Economic and Strategic Affairs and led the planning of the health care and health industry programs of the National Development Plan.Since June 2006 he has been the executive director of the Med-Econ Ltd., which main profiles are: project management, organization development consulting, planning and management of EU projects and programs.

Dr. Arne C. Faisst, CEO, Mathys Ltd Bettlach, Germany

Dr. A. Faisst has extensive management experience in the medical technology industry at home and abroad. As a member of the Board Dr. A. Faisst internationally since 1997 for Mathys worked in various capacities. In April 2006 he was appointed Chief Operating Officer (COO) before being appointed CEO. As COO of Bettlach orthopedics company Mathys he was awarded by the Wall Street Journal Europe for outstanding performance. Dr. Arne-C. Faisst ended at GSBA Zurich with a Master of Business Administration (MBA) is not only successful, he was honored for his outstanding performance even.At a graduation ceremony at the ETH in Zurich he was awarded “The Wall Street Journal Europe Outstanding MBA Award.” His thesis work was awarded the Master to be the best thesis of the MBA program of the GSBA Zurich. “A great performance that makes us proud and we confirmed the appointment of Arne Faisst is COO a year ago as a proper and important step forward has one more time,” said Hugo Mathys, CEO of Mathys group.


Luis has 15 plus years of challenging projects and turn arounds within the technology industry and now on the Medical Devices/Biotech market. From infrastructure and box moving businesses to high level consulting projects. From building services practices from scratch or changing sales forces from products to solutions approaches to dealing with tough customers like Telmex.Focusing on the concepts behind market trends and on the team required to deliver the goods I have been collecting interesting experiences that are available for sharing. Responsible for the overall business (P&L) performance of our core business in Latin America. Developing and implementing our Sales & Marketing CRDM strategy for 5 regions and more than 20 countries with the goal of sustaining our regional leadership while developing target markets like Brazil, Mexico, Colombia, Puerto Rico and Argentina.

Juozas Galdikas, Director, State Health Care Accreditation Agency, Lithuania

In 1983 Juozas got a doctorate from the Faculty of Medicine at Vilnius University. He was Professor at the Clinic for Vascular Surgery at the same university. From 1995 through to 1996 he was Head of Health Care, Sanitation and Hygiene Division of the Vilnius municipality and in 1996 he became a Member of the Parliament for The Republic of Lithuania. He was Minister of Health of the Republic of Lithuania before taking over as Director of the State Health Care Accreditation Agency under the Ministry of Health.In the past he has prepared amendments to the laws, needed for the introducing of the Compulsory Health Insurance and in 1997 started the reformation of Lithuanian Health system from Semashko model (centralization of management and financing of health system) to Bismark model (insurance based health system with the principles of solidarity, accessibility and equity

PAGE EIGHT

SpeakerBiogr aph ies

PAGE SEVEN

William Gartner, CEO, Provista Life Sciences, USA

Mr. Gartner has 20 issued patents and more than 35 years’ experience in the environmental and medical fields, with an extensive history of product development, operational oversight, corporate acquisitions and technology transfer. He founded Gartner Research & Development Company, which offered contract product development services and licenses of its own patented products. As a branch of Gartner R&D, he created a water and wastewater testing laboratory, which successfully grew into a national multimillion-dollar network of environmental labs. Mr. Gartner sold Gartner R&D to the Ocean Group, which later became the largest network of labs in the United States. He then acquired a small laboratory in Phoenix, which he grew to five locations in four states with nearly 200 employees and a full-scale radiochemistry lab. Mr. Gartner’s patents range from water purification units to a self-test for Alzheimer’s disease.

Dr. Iñaki Gutiérrez-Ibarluzea, Knowledge Manager, Osteba, The Basque Office of HTA

Iñaki Gutiérrez-Ibarluzea BSc, MSc, PhD is the Knowledge Manager and Coordinator of the early awareness and alert system of Osteba, the Basque Office for HTA. He is member of the HTAi ISG on information resources, the HTAi ISG group on Membership and dissemination and chairs the HTAi-ISG on disinvestment of technologies of low-added value. He has been collaborating in different European Union funded projects such as: InnoHTA, EunetHTA, PHGEN I and II and Health ClusterNet playing different roles. He is also coordinating different projects at the Spanish level such as: GENTecS or Information resources group.He is currently the chairman of EuroScan, the International Network for the identification and assessment of new and emerging health technologies. He is also professor at the Nursing School of the Basque Health Service Osakidetza and collaborates with the University of the Basque Country and the University Oberta of Catalonia in different academic activities. He was actively involved in the e-text on HTA promoted by the ISG on information resources and in the development of the HTAi vortal on information resources. At the Spanish level he coordinates the Spanish Group of Agencies for the Identification and assessment of new and emerging technologies and is member of the groups for the assessment of obsolete technologies and the development of post-introduction systems for the assessment of health technologies leaded by the Galician Agency (Avalia-T).

Jeffrey C. Lerner, Ph.D., President & Chief Executive Officer, ECRI Institute, USA

Dr. Jeffrey C. Lerner has served since 2001 as President and Chief Executive Officer. ECRI Institute (formerly the Emergency Care Research Institute, founded in 1968) is the world’s largest independent nonprofit health technology assessment organization that researches the best approaches to improving patient care. It is a Collaborating Center of the World Health Organization with terms of reference in technology, risk management and patient safety. It is also designated as an Evidence-based Practice Center (EPC) by the U.S. Agency for Healthcare Research and Quality (AHRQ) and is listed as a Patient Safety Organization (PSO) by the U.S. Department of Health and Human Services. ECRI Institute maintains a full time staff of over 300 in offices in North America, Europe, Middle East, and Asia Pacific. Six vice presidents report to the president. Prior to this, he held the position of Vice President for Strategic Planning for 17 years. He played the key role in setting the course for ECRI Institute’s transition from its origins as a medical device evaluation laboratory to a broader health research organization that assesses clinical procedures and drug therapies in addition to medical devices, worldwide..

Paula Polman, Coordinator, Dutch Health Care Insurance Board (CVZ), Netherlands

Paula Polman completed her study in Utrecht as a social psychologist in 1977. She subsequently worked for five years as advisor for a regional organisation for women’s health and welfare. In the following years, as advisor of the Ministry of Health, she developed the governmental policy on prevention of child abuse and sexual violence and the assistance for victims. After 5 years she switched to another topic. The innovation of the mental health care sector in the direction of a more client centered approach became her responsibility at the Ministry. In the meantime she completed studies on public health (MPH).In 2000 she became head of the Reimbursement Department for long term care of the Dutch Health Care Insurance Board (CVZ). Since 2004 Paula is Coordinator of the Reimbursement Department for medical procedures, medical devices, paramedics and dental health care.

Ad Schurman, Head of Business Contact Centre and International Affairs, CVZ, NetherlandsAd Schuurman completed his study in Utrecht as a clinical psychologist in 1980. He subsequently worked for five years as head of a patients’ association. In the following years, as staff officer of a regional Institute for Mental Health, he organized the cooperation the Regional Institutes for Mental Health and the other healthcare organisations. After spending several years as manager of the national project relating to pharmacotherapeutic dicisionmaking, he became head of a geriatric department. In the meantime he completed studies on management consultancy and on business administration (MBA). As deputy director of the Dutch College of General Practitioners (NHG), he set up the Electronic Prescription System. In recent years, as manager of the Pharmacy department, he was responsible for the pharmacy-related activities of the CVZ. Since 2006 he was head of the Reimbursement Department, covering the heathcare reimbursement issues in the Netherlands. In 2006 he became President of the Medical Evaluation Committee (MEDEV) in Brussels, in which reimbursement authorities of 18 EU countries cooperate. Since 2010 is Ad is Head of Business Contactcentre and International Affairs of the Dutch Health Care Insurance Board (CVZ).

Dr. Stephen Stefani, President, ISPOR, Chair of Health Care Policymakers & Payers Committee, ISPOR Latin America Consortium, Coordinator of the Oncology Unit, UNIMED, Brazil

Stephen graduated from the Universidade Federal do Rio Grande do Sul Medical School, in Brazil, in 1994. He was clinically trained in Internal Medicine and Clinical Oncology by the Hospital de Clinicas de Porto Alegre and attended the University of California San Francisco, as a clinical fellow. Holding an MBA in health business, he is a professor of a post-graduation course with the Fundação Universidade UNIMED and Escola Superior de Gestão e Ciências da Saúde. Dr. Stefani also serves as a regular consultant for the major private health insurance company in Brazil, with over 70 companies in his portfolio. Currently he is the Coordinator of the Oncologic Drugs Benefits Program of CAPESESP (self-financed insurance linked to Ministry of Health) and Coordinator of the Oncology Unit of UNIMED (with 11 million people covered). He is the author or co-author of over 50 national and international arbitrated journals and chapters of books about oncology, medical audit and pharmacoeconomics and has have presented more than 150 lectures. His work in pharmacoeconomics is focused on cancer related therapy. He is also the founder of the ISPOR Brazilian Chapter and Chair of the ISPOR Latin America Health Care Policymakers & Payers Committee.

Sinisa Tomic, Head of Agency of Medicinal Products & Medical Devices, Croatia

Siniša Tomić is Head of the Croatian Agency for Medicinal Products and Medical Devices and adjunct associate professor at the University of Split. He studied medical biochemistry at the University of Zagreb, Croatia and received his Ph.D. in Biochemistry at the Friedrich Schiller University of Jena, Germany, in 1996. From 1996 to 1999 he was postdoc in pharmaceutical biotechnology at the National Research Council of Canada and McGill University in Montréal. He was awarded a Max Planck Society Fellow and Canadian Government Visiting Fellowship.In 1999 he is back to Zagreb and worked at the Ministry for European Integration and in he 2001 moved to Rijeka and worked for JGL Ltd. where he gained experience in generic industry. In 2003 he took over as head of the newly established Agency. Professor Tomić teaches regulatory affairs and pharmaceutical marketing at three Croatian universities and presides over the Regulatory section of the Croatian Pharmaceutical Society.

Dr. Geoff Wilson, Head of Health Economics & Reimbursement EMEA, GE Healthcare, UK

Geoff earned his Bachelor’s degree and Doctorate in microbiology and cell biology, he has later completed a Master’s degree in Health Economics from City of London University, UK. His current areas of interest include: Demonstrating value to support optimal payment for diagnostic procedures wherever these are carried out – in hospitals & clinics, outpatient, in the community, etcDr Wilson’s previous professional appointments include: European Product Manager for in vitro diagnostics with Abbott Diagnostics; 3 years with Allergan as their Head of Pricing, Reimbursement & Health Economics for therapeutic applications of BOTOX® across Europe, Middle East & Africa (EMEA). Prior to Allergan, Geoff was with GlaxoSmithKline (GSK) for 18 years in various positions of responsibility within Europe and globally for pricing & reimbursement of pharmaceutical products. He is currently the Head of Health Economics & Reimbursement for EMEA at GE Healthcare.

SpeakerBiogr aph ies

PAGE NINE

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Surgical Devices, Interventions & Implants


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MEDICAL DEVICE L E A D E R S F O R U M

Ber l in , Germany 21-23 May, 2012

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