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