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A roadmap to implement EU-IVDR compliance program
13 June 2017
A roadmap to implement EU-IVDR compliance program

The workshop will kick off with a brief overview of key changes and timelines associated with hard and soft transitioning, and will provide high level input into building a compliance program to implement the new EU-IVDR. The remainder of the workshop will focus on the practical approach with a “hypothetical” in vitro diagnostic medical device manufacturer. A key element in the workshop will be the ‘‘How to’ questions, such as ‘how to understand critical impacts’, ‘how to persuade my management to prepare budget/resources’, ‘how to prepare the roadmap’, etc.

Workshop LEADER

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Gert Bos

Executive Director & Partner , Qserve Consultancy

Qserve Consultancy

 

Qserve offers practical support to accelerate global market approval of medical devices. Our philosophy is to optimize and customize advice; our practical approach supports each individual company in the most efficient and cost-effective manner. Qserve, as a global leading consultancy, provides a complete and global solution by offering a complete package of regulatory, quality and clinical services. Global presence, local service.

Workshop agenda

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13:30

Registration & Coffee

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14:00

The upcoming IVDR – an 8 step implementation

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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15:00

CASE part 1 – Impact analysis

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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16:00

Afternoon Tea

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16:30

CASE part 2 – Portfolio analysis and preparation part 3

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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17:00

CASE part 3 – presentation of plan to the Board

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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17:30

Close of Workshop

Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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, SAE Media 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@saemediagroup.com

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