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To the pharmaceutical industry the rigour of experimental proof, the objectivity of a risk benefit analysis, combined with value based pricing poses a significant challenge to the development of novel compounds, particularly those destined for primary care. To the humans who work in Pharmaceutical companies, there is the undeniable truth that Healthcare budgets are not bottomless pits and there is a gap between what needs to be resourced and what can be afforded either by direct private payment, through tax, or through insurance premium.
Pharmaceutical companies turn increasingly to Orphan and Rare diseases to reduce their reliance on primary care medicines. The trials are smaller, cheaper and less exacting, the reimbursement situation is more benign and resource required to commercialise is much reduced. The number of Orphan drugs approved since the turn of the century has climbed to about 1 in 3 in the USA; in 2015 the share was over 40%. It is expected that by 2018, orphan drugs will account for 16% of global branded drug sales.
Just as the viewer has become inured to the tears tracking down the face of an orphan in Somalia, so has the government become inured to the cries of apologists for Orphan drugs.The party is well and truly over.


This is a practical workshop is designed to review approaches to orphan drug approval.
At the heart of the workshop is the story that needs to be told. A story that starts when the first glimmer appears in a research scientists eye, and that flourishes when a drug launches to change lives.

The Workshop is broken into three parts,
Part 1 is about how to tell your story.
Part 2 is about how to develop your story, by building the evidence
Part 3 is about telling your story to the most important audience, the regulators who will approve it and the reimbursement authorities that will pay for it.


 

Those working the rare disease industry whose responsibilities directly involve orphan drug approval.

Workshop LEADER

keynote-img

Malcolm Allison

Director and Owner, InterComm International Ltd

Malcolm Allison is a Director at InterComm International, a Medical Communications company. He has 35 years of experience in pharmaceutical marketing, half of which have been devoted to the development and commercialization of Orphan Drugs.

InterComm International Ltd

 

InterComm is a Healthcare Communications company based in Cambridge, England.
We are dedicated to writing that excites, educates and informs. We pride ourselves on getting the right message to the right people at the right time. We know you have a story we want to help you tell it.
 

Workshop programme

13:30 Registration & Coffee

14:00 Introduction from Workshop Leaders

Malcolm Allison

Malcolm Allison, Director and Owner, InterComm International Ltd
View Bio

14:30 Topic 1: Decide the story

Malcolm Allison

Malcolm Allison, Director and Owner, InterComm International Ltd
View Bio

15:00 Topic 2: Get the facts

Malcolm Allison

Malcolm Allison, Director and Owner, InterComm International Ltd
View Bio

15:30 Afternoon Tea

16:00 Topic 3: Tell the story

Malcolm Allison

Malcolm Allison, Director and Owner, InterComm International Ltd
View Bio

16:20 Q&A

Malcolm Allison

Malcolm Allison, Director and Owner, InterComm International Ltd
View Bio

16:30 End of Workshop

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VENUE

Crowne Plaza Berlin - Potsdamer Platz

Hallesche Str. 10, Berlin, Germany

The Crowne Plaza Berlin - Potsdamer Platz offers Berlin Zeitgeist and a big city feeling. The listed building of the former Postpalais exudes the high-class elegance reminiscent of the Bohemian circles of the 1930s. Broad corridors with natural stone floors, high ceilings, wood panelling and an open fire in the lobby convey glamorous Berlin city life. Art Déco elements and a well thought out design ensure freshness and modernity. Generous rooms and suites, an elegant restaurant with a show kitchen and the stylish THE POST Bar take the Berlin hotel scene to a new level.

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Crowne Plaza Berlin - Potsdamer Platz

Hallesche Str. 10
Berlin 10963
Germany

Crowne Plaza Berlin - Potsdamer Platz

The Crowne Plaza Berlin - Potsdamer Platz offers Berlin Zeitgeist and a big city feeling. The listed building of the former Postpalais exudes the high-class elegance reminiscent of the Bohemian circles of the 1930s. Broad corridors with natural stone floors, high ceilings, wood panelling and an open fire in the lobby convey glamorous Berlin city life. Art Déco elements and a well thought out design ensure freshness and modernity. Generous rooms and suites, an elegant restaurant with a show kitchen and the stylish THE POST Bar take the Berlin hotel scene to a new level.

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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