This deck was presented at the 2013 Food & Drug Law Institute's Advertising & Promotion conference. I provided advice to people responsible for the selection and/or upgrade of electronic promotional review systems used in the review and approval of marketing materials for prescription products.

1. Deciding on an electronic
review system
Dale Cooke
Digitas Health

2. • Faster approval times
• Complete audit trail
• Lower agency costs
• Improved compliance
2
e-System Benefits

3. • If the wrong system is implemented or the
system isn’t implemented well, the costs are
severe:
• Cost-overruns and delays during implementation
• Frustrated users
• Confused agency partners
• Compliance risks
• Increased cost for reviewing and approving
materials (both internally and from agency
partners)
3
e-System Drawbacks

4. Relatively Few
Established Players
Aprimo
Veeva Vault
Zinc Ahead
Documentum
Next Docs

5. • Agency access
• One log-in per agency is preferred
• Automatic agenda creation
• Opens job codes well before submitting projects
• Audit reports
• Auto-generates certain communications (approval to use,
expiration notices, etc.)
• Clean user interface
• Maintains a library of references
• Ability to integrate with other systems (procurement, print
production, Digital Assessment Management (DAM))
• How are updates rolled out?
5
Key Features

6. Key Features (cont’d)
• Mobile access (iPad & iPhone)
• Immediate accessibility of meeting markup
• Ability to link associated projects (e.g., an outer envelope, cover
letter, and brochure)
• Automatically track expiration dates for annual review and generate
renewal reminders
• Support all standard web browsers and updates
• Allow for integration with FDA Gateway
• Accommodate multiple regions and approval processes
• Deal with co-promote/joint venture partners
• Understand the hosting environment and whether it can
accommodate volume demands

7. Reference Handling
• Maintain a library of acceptable references
• New references should be vetted by medical
reviewer prior to system addition
– Ensure this isn’t too time consuming
– Avoids duplicate references
• Link references to projects using them
• Accommodate multiple links to and from the same
claim and/or reference
• Core claims documentation
• Be wary of systems that link too much (weigh the
costs and benefits of traceability)

8. Keys to a Successful
Implementation
• Involve the right people in the
implementation
• Train at the right time (Goldilocks rule, not
too soon, not too late)
• Understand customization vs.
configuration distinction
– Avoid customization
• Establish a team of champions with
local/regional/departmental representation

9. Dale Cooke
VP/Group Director, Regulatory Review
Dale Cooke is the head of the regulatory department for Digitas Health. He
has worked with more than 30 pharmaceutical, biotech, and medical device
clients and with Medical-Legal-Regulatory committees around the world from
offices in Philadelphia, New York, San Francisco, Boston, and London. Dale
advises clients on FDA enforcement actions and provides recommendations
for compliance with FDA regulations, with a focus on issues involving the
Internet and emerging technology. His insights have been featured in the
Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews,
PharmExec, and others. Dale is a member of the Regulatory Affairs
Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI).
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to
speak at industry conferences on topics including FDA enforcement trends,
best practices for review processes, global review practices, and
pharmaceutical involvement in social media.
Dale earned his B.A. in Philosophy from Southern Methodist University and
an M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health.