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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
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
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.