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WORKING WITH NATIONAL REGULATORS AND HEALTH AUTHORITIES What to expect and what to hope for ALBERT FARRUGIA SENIOR DIRECTOR GLOBAL ACCESS PLASMA PROTEIN THERAPEUTICS ASSOCIATION International Patient Organization for Primary Immunedeficiencies Congress,  Hertogenbosch, the Netherlands October 2008
Australian Treasury projections Effect of age group on health spending
Australian Treasury projections Spending on health
Australian Treasury projections Spending on health – sectorial breakdown
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FDA PEI TGA
Regulation of plasma derivatives ,[object Object],[object Object],[object Object]
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Regulation by the NRA … assuring quality, safety & efficacy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
“ The core of the voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interest and is recommended by either a consortium of consumer-oriented organizations or other interested persons.”
Industry and regulators ,[object Object],[object Object],[object Object],[object Object],[object Object]
“ Cheshire puss” she begun “would you please tell me which way I ought to go from here?”  “That depends on where you want to get to” said the cat. ,[object Object],[object Object],[object Object],[object Object],Alice in Wonderland
 
 
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Interacting with Government

  • 1. WORKING WITH NATIONAL REGULATORS AND HEALTH AUTHORITIES What to expect and what to hope for ALBERT FARRUGIA SENIOR DIRECTOR GLOBAL ACCESS PLASMA PROTEIN THERAPEUTICS ASSOCIATION International Patient Organization for Primary Immunedeficiencies Congress, Hertogenbosch, the Netherlands October 2008
  • 2. Australian Treasury projections Effect of age group on health spending
  • 3. Australian Treasury projections Spending on health
  • 4. Australian Treasury projections Spending on health – sectorial breakdown
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  • 13. “ The core of the voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interest and is recommended by either a consortium of consumer-oriented organizations or other interested persons.”
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Editor's Notes

  1. I’d just like to conclude by encouraging you to engage as early as you can with the regulator with your development plans.with biotherapueitics, we recognise that the expertise is with you, while the responsibility to the public is at least partially with us. Please work with us, so that we can continue to deliver the best therapies to the Australian public.