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Pope Woodhead has extensive experience in the
development and implementation of bespoke regulatory advisory/challenge
panels.
| We offer: |
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Expert panel meetings providing
independent advice to answer critical questions about your
product |
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Assembly of an optimal panel, tailored to
your needs, from our wide network of knowledgeable professionals
with EMEA, FDA and national health authority experience |
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The opportunity to identify and test regulatory
and clinical strategies, preferred developmental routes, and
solutions to specific developmental and commercial issues |
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Recruitment of panel members, preparation
of briefing documents, meeting logistics and reporting of
outcomes. |
| Recent projects: |
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Solutions to specific
safety, trial design, preclinical and reimbursement
issues for a phase III CNS drug |
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Clinical programme design to meet
FDA/EMEA requirements in a novel therapeutic area with
little regulatory guidance or developmental experience |
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Acceptability of manufacturing process
changes and clinical issues for a biological |
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Optimising the regulatory pathway
for a phase IIb metabolic disease drug with different
indication options and facing evolving regulation. |
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