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This interactive workshop will explore strategies on how to optimally use randomised clinical trials for economic data collection and economic evaluation.

The need of economic analyses to support pricing, reimbursement and funding of drugs is constantly increasing and several factors, from demography to the aftermaths of the financial crisis, are likely to aggravate this situation. Phase II and III clinical trials are key as potential sources of information on benefits and resource utilization related to a new drug at the time when pricing/reimbursement evaluations take place. Although there are limitations to economic evaluations based on RCTs, they are generally considered to be credible. And, if planned and designed diligently, RCTs can be a cost-effective source of crucial economic information.


 Key Topics

  • Identification of phase II to III randomised clinical trials (RCTs) suitable for collecting economic data
  • Design (or amend existing designs) to optimize economic data collection
  • Considerations for the analyses of data from RCTs
  • “Pragmatic” RCTs for economic evaluation
  • Limitations of economic evaluations based on RCTs

About the Workshop Leader

 

 

Klaus Hieke is Managing Director and Co-founder of NEOS Health. Klaus has almost 20 years of top-tier pharmaceutical industry experience on national and international level. With a background in business administration from special training programs at Bayer and the University of York, he held several positions in marketing and sales at Bayer and Hoffmann-La Roche before joining the Global Health Economics and Pricing Department at Roche in Basel. There he designed and implemented global health economic, pricing and reimbursement strategies for several products before co-founding NEOS Health in 2000. He has completed a large number of projects in the areas of market access, pricing, reimbursement and health economics for the pharmaceutical, biotech and medical device industry. For several projects he has designed, implemented and reported economic evaluations integrated in or conducted alongside RCTs.

 


About the Organisation

 

  

NEOS Health was founded in 2000 as a consultancy specialising in market access, pricing and reimbursement, health economics and marketing strategy. NEOS Health offers services in strategy development and project management on a national and international level. Cooperating with partners in the major European markets, NEOS has a solid ability to stay abreast of the latest developments in the European health care landscape, particularly in the German-speaking countries. NEOS Health was formed by people with extensive industry experience and in-depth knowledge of the above mentioned areas.

 

Workshop programme

13:00 Registration and coffee

13:15 Welcome and introduction

13:30 Economic data collection and economic evaluations in RCTs – an overview of opportunities and challenges

14:30 Workshop exercise: 2 to 3 person teams supported by the workshop leader

15:30 Coffee break

15:50 Presentation of workshop results

16:30 Personalised strategic recommendations

17:00 Close of workshop

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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)

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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.

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