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The Value Story is divided into 'bite size chunks' of information which are easy to understand and assimilate by Payer customers, many of whom are generalists and not specialists in the disease area or in complex health economics. The Value Story sets out the best order to present the information to build Payer customer ingredient phentermine belief in the value 2mg xanax online no prescription of the new medicine The Value Messages are the individual elements of each step of the Value Story which are communicated to the Payer Customer, setting out each compelling message 'headline', sub messages which support the main headline ingredient phentermine message, the data which supports this message headline, and the reference sources for this data providing robust support for each message throughout the Value Story Each element of the Value communication should be thoroughly tested & validated with Payer Customers in the key markets TM. GALBRAITH WIGHTp^t^^n Pharma industry still making too many unforced errors 4 R&D focus is still marketing authorisation, not reimbursement GALBRAITH LCWIGHT^B In most Pharma companies, R&D is still incentivised only on regulatory rather than reimbursement approval MICE International NICE accreditation NICE Evidence Services J00S Tenders i*C£ wetsae development 1.R&D focus on explicit needs from FDA & EMA to achieve marketing authorisation - best chance of regulatory approval is 'cut & paste' what got approved before 2.Little evidence of TPPs which addresses Payer needs ingredient phentermine & requirements - such as a Target Reimbursable Product Profile (TRiPP(c)) 3.Traditionally, commercial involvement starts at Phase III - too late to shape the brand T*Cf. Pathways , Quality standards Horns > Atom mCG > Scisnotic aWce > Advice alongside me regulators About nice Advice alongside the regulators Who we are What we do How we work Advice alongside the European Medicines Agency (EMA) Ih the EMA are possible and welcome Please contact us to Advice alongside the Medicines and Healthcare Products Regulatory Agency (MHRA) companies also nave tne option to request a joint scientific advice meeting with tne MHRA ana nice to discuss their plans for the Phase lit development ol a medeinal product.

Following a meeting with the company, the MHRA and nice um produce hydrocodone withdrawl symptoms separate advice ooc uments to answer tne respec live questions raised Dy the company companies interested in taking up me option ot joint advice are asked to provide •Poet synopsis ol the product tor which advice is sought > the stage ot its development •the nature or the issues "nd confirm that •they nave haa previous experience or scientific aovce trom NICE and MHRA with other products i they have not new tramadol cod received scientific advice tram the Committee tor Medicinal Products tor Human Use (CHMP) nor submitted a marketing atnnonsation application on tne lopies they wish to reserve advice on.



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