P R E S E N T A T I O N
(Without Knocking Down the Regulatory Fence)
Liz RubyCo-founder, Partner
RBK Healthcare Marketing
• Decrease the dread
• Do our due diligence
• Increase our situational awareness
• Be realistic about timing
• Build relationships early and often
• Risk management
• “First do no harm”
• Ensure consistency
• Agencies: “Our concepts will be
crushed!”
• PRCs: “Marketers will be unprepared!”
• Product managers: “My initiative will
fizzle out!”
• API: consciously choosing to assume
that colleagues operate in the best
interest of the company
• Opens up the conversation: can explore
differences/concerns from place of
curiosity rather than conflict
• “Yes” at one time (in one context) does
not mean “yes” forever
• Solid, vetted substantiation
• Know the piece inside and out
• And …
• PRC members:
– Pharmacists
– Nurses
– Physicians
– Lawyers
– Quality control
• Not marketers
• Provide context– Purpose
– Target audience
– Distribution channels
– Desired outcome
• Move review up the chain of command when appropriate
• Have realistic turnaround expectations for review
• Wrangle references
– Research needs rigorous for new
claims/launches
• Multiplier effect: acute on large projects
• Uploading
• Entire process can be time-consuming
• Concept review: get ideas in front of
reviewers in the early stages
• Agency participation: give us a seat at
the table to hear feedback and probe
for clarity