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Real-Life Compliance Solutions  Part I:  Dissemination of Promotional, Scientific and Educational Content  Navigating Comp...
Agenda <ul><li>Housekeeping & Introductions   (5 min) </li></ul><ul><li>Real-Life Compliance Solutions </li></ul><ul><ul><...
Speaker Introductions <ul><li>Elsa Chi Abruzzo </li></ul><ul><ul><li>President, ARAC, LLC </li></ul></ul><ul><li>Steven Sk...
PACE:  A Collaborative Process <ul><ul><li>Elsa Chi Abruzzo </li></ul></ul><ul><ul><li>President, ARAC, LLC </li></ul></ul...
Changing Landscape <ul><li>Regulatory, Compliance and Legal </li></ul><ul><ul><li>Expanding breadth and depth of regulatio...
Learn from GMP and DHR <ul><li>Response to quality issues </li></ul><ul><ul><li>Inefficient processes    Efficient </li><...
What is PACE?
P repare <ul><li>Obtain cross-functional executive approval </li></ul><ul><li>Establish cross-functional content review co...
A nalyze <ul><li>What are claims made </li></ul><ul><li>Compare claims against marketing standards book – time basis for u...
C ategorize <ul><li>Associate material with appropriate category </li></ul><ul><ul><li>Examples:  General Promotional (G),...
E xecute <ul><li>Educate and train across and up and down </li></ul><ul><ul><li>Document training and certification </li><...
Controlled Dissemination <ul><li>Manual fulfillment – frequent updates? </li></ul><ul><ul><li>Annual training – will they ...
Communications History Record Prepared for the Worst <ul><ul><li>Steven Skwara </li></ul></ul><ul><ul><li>Partner, Epstein...
CHR:  Start with End in Mind <ul><li>Clear, documented process </li></ul><ul><ul><li>Controlled library </li></ul></ul><ul...
Expense and Distraction <ul><li>Responding to inquiries from third-parties </li></ul><ul><ul><li>Regulatory </li></ul></ul...
E-Discovery Information Retrieval 50-80% of costs Attorney Fees 20-50% of costs
Responding to Ad Hoc Inquiries <ul><li>Retrieve quickly </li></ul><ul><li>Confident </li></ul><ul><li>Comprehensive </li><...
Litigation and Investigations <ul><li>Shape legal strategy </li></ul><ul><ul><li>Organized database allowed quick overview...
Recent CIAs:  Material Dissemination <ul><li>Independent gatekeeper </li></ul><ul><li>Tracking database </li></ul><ul><ul>...
Prolifiq for Life Sciences: Digital CMS with CHR <ul><ul><li>Maureen Shaffer </li></ul></ul><ul><ul><li>Vice President, Li...
Sales-Friendly Compliance
Simple, Powerful Rulebook
Robust Tracking and Monitoring
Questions & Answers <ul><li>Elsa Chi Abruzzo, President, ARAC </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><li...
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Compliant Dissemination of Promotional and Educational Material

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Navigating compliance challenges od product-related communications series.

Sponsored by AdavMed, Epstein Becker Green and ARAC, LLC

Published in: Health & Medicine
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Compliant Dissemination of Promotional and Educational Material

  1. 1. Real-Life Compliance Solutions Part I: Dissemination of Promotional, Scientific and Educational Content Navigating Compliance Challenges of Product-Related Communications Series (75 min)
  2. 2. Agenda <ul><li>Housekeeping & Introductions (5 min) </li></ul><ul><li>Real-Life Compliance Solutions </li></ul><ul><ul><li>PACE: A Four-Step Process (20 min) </li></ul></ul><ul><ul><li>CHR: Prepared for the Worst (20 min) </li></ul></ul><ul><ul><li>A Word from our Sponsor (5 min) </li></ul></ul><ul><li>Questions and Answers (20 min) </li></ul><ul><li>Closing Remarks (5 min) </li></ul>
  3. 3. Speaker Introductions <ul><li>Elsa Chi Abruzzo </li></ul><ul><ul><li>President, ARAC, LLC </li></ul></ul><ul><li>Steven Skwara </li></ul><ul><ul><li>Partner, Epstein Becker & Green, P.C. </li></ul></ul>
  4. 4. PACE: A Collaborative Process <ul><ul><li>Elsa Chi Abruzzo </li></ul></ul><ul><ul><li>President, ARAC, LLC </li></ul></ul><ul><li>(20 min) </li></ul>
  5. 5. Changing Landscape <ul><li>Regulatory, Compliance and Legal </li></ul><ul><ul><li>Expanding breadth and depth of regulations and guidelines </li></ul></ul><ul><ul><li>Increasing FDA, DOJ and SEC (FCPA) enforcement </li></ul></ul><ul><li>Sales and Marketing </li></ul><ul><ul><li>More decision makers </li></ul></ul><ul><ul><li>More sites of service </li></ul></ul><ul><li>Less time and fewer resources </li></ul>
  6. 6. Learn from GMP and DHR <ul><li>Response to quality issues </li></ul><ul><ul><li>Inefficient processes  Efficient </li></ul></ul><ul><li>Central aspects of GxP are: </li></ul><ul><ul><li>Traceability: the ability to reconstruct history </li></ul></ul><ul><ul><li>Accountability: the ability to resolve who has done what and when </li></ul></ul><ul><li>PACE Process + Implement = CHR </li></ul>
  7. 7. What is PACE?
  8. 8. P repare <ul><li>Obtain cross-functional executive approval </li></ul><ul><li>Establish cross-functional content review committee </li></ul><ul><ul><li>Strategic Governance Structure with CCO Oversight and/or, Tactical Cross-Functional PRC </li></ul></ul><ul><ul><li>SOP with objective criteria with approval form containing how and where this will be used </li></ul></ul><ul><ul><li>Regularly scheduled meetings </li></ul></ul><ul><li>Broaden purview to increase branding and compliance </li></ul><ul><ul><li>Solicit materials for review, including at the concept stage </li></ul></ul><ul><ul><li>Convince company employees broadly to submit materials for review </li></ul></ul>
  9. 9. A nalyze <ul><li>What are claims made </li></ul><ul><li>Compare claims against marketing standards book – time basis for updating </li></ul><ul><li>Which indications allowed </li></ul><ul><li>Geographical rule sets </li></ul><ul><ul><li>Federal/OUS, State, Local/Hospital or OUS: EU, Pac Rim, LA </li></ul></ul><ul><li>Company Guidelines </li></ul><ul><li>Ethical/Public Opinion: Fair balance, transparency </li></ul><ul><li>Assume rapid dissemination to competitors, FDA et al. </li></ul>
  10. 10. C ategorize <ul><li>Associate material with appropriate category </li></ul><ul><ul><li>Examples: General Promotional (G), Clinical Trial (C), Unapproved Use Journal Articles (Good Reprint Practices) (R), Unsolicited Requests (U), Disease Awareness (D), Internal Use Only (I) </li></ul></ul><ul><ul><li>Include categorization in PRC form, SOP and final approved material code </li></ul></ul><ul><ul><li>Category is approved along with the material </li></ul></ul><ul><li>Category drives rules = Consistency </li></ul><ul><ul><li>Disclaimers, risks, indications, approved labeling </li></ul></ul><ul><ul><li>Author and study funding disclosures for reprints </li></ul></ul><ul><ul><li>Approval routing for review of clinical trial content </li></ul></ul><ul><ul><li>Data collection for unapproved use reprint requests </li></ul></ul>
  11. 11. E xecute <ul><li>Educate and train across and up and down </li></ul><ul><ul><li>Document training and certification </li></ul></ul><ul><li>Audit and monitor sales behavior </li></ul><ul><ul><li>Regulations, CIAs </li></ul></ul><ul><li>Monitor customer usage and close-loop learning to improve materials </li></ul><ul><li>Listen, modify and repeat </li></ul>
  12. 12. Controlled Dissemination <ul><li>Manual fulfillment – frequent updates? </li></ul><ul><ul><li>Annual training – will they remember? </li></ul></ul><ul><ul><li>Medical Affairs – low on resources? </li></ul></ul><ul><li>Intranet – how often do reps log in? </li></ul><ul><li>Digital CMS </li></ul><ul><ul><li>Make the complex simple with technology </li></ul></ul><ul><ul><li>Efficiency and cost-savings with processes </li></ul></ul><ul><ul><li>Two choices </li></ul></ul><ul><ul><ul><li>Modify non industry-specific with compliance rules </li></ul></ul></ul><ul><ul><ul><li>Choose industry-specific with compliance rules </li></ul></ul></ul>
  13. 13. Communications History Record Prepared for the Worst <ul><ul><li>Steven Skwara </li></ul></ul><ul><ul><li>Partner, Epstein Becker & Green </li></ul></ul><ul><li>(20 min) </li></ul>
  14. 14. CHR: Start with End in Mind <ul><li>Clear, documented process </li></ul><ul><ul><li>Controlled library </li></ul></ul><ul><ul><li>Proof of meaningful compliance program </li></ul></ul><ul><li>End-to-end traceability </li></ul><ul><ul><li>Monitoring and immediate action </li></ul></ul><ul><ul><li>Transparency </li></ul></ul><ul><li>Built-in electronic communications history record (CHR) </li></ul>
  15. 15. Expense and Distraction <ul><li>Responding to inquiries from third-parties </li></ul><ul><ul><li>Regulatory </li></ul></ul><ul><ul><li>Investigatory </li></ul></ul><ul><ul><li>Litigation </li></ul></ul><ul><li>Staggering costs for information retrieval </li></ul><ul><ul><li>“ All communications between sales and providers” </li></ul></ul><ul><ul><li>Imaging one BlackBerry ~$500/ea before attorney review </li></ul></ul><ul><ul><li>Decentralized information sources multiply costs </li></ul></ul><ul><ul><li>May exceed attorneys’ fees </li></ul></ul>
  16. 16. E-Discovery Information Retrieval 50-80% of costs Attorney Fees 20-50% of costs
  17. 17. Responding to Ad Hoc Inquiries <ul><li>Retrieve quickly </li></ul><ul><li>Confident </li></ul><ul><li>Comprehensive </li></ul><ul><li>Pinpoint individuals, recipients, geography, products </li></ul><ul><li>Competition, FDA or other external inquiries </li></ul>Rx Compliance Report, Vol. VIII, Issue 7/May 5, 2009
  18. 18. Litigation and Investigations <ul><li>Shape legal strategy </li></ul><ul><ul><li>Organized database allowed quick overview of sales behavior and interactions: who sent what when to whom </li></ul></ul><ul><li>Time and cost savings </li></ul><ul><ul><li>Opportunity to argue that centralized system may allow cost shifting for additional discovery work </li></ul></ul><ul><li>In addition to ad hoc advantages </li></ul>
  19. 19. Recent CIAs: Material Dissemination <ul><li>Independent gatekeeper </li></ul><ul><li>Tracking database </li></ul><ul><ul><li>Substantive requirements </li></ul></ul><ul><ul><li>e.g., VT law </li></ul></ul><ul><li>Monitoring triggers </li></ul><ul><ul><li>e.g., high volume of purportedly unsolicited requests </li></ul></ul><ul><li>Practical Compliance Advice: Recent CIAs </li></ul><ul><ul><li>www.prolifiq.net/lifesciences </li></ul></ul><ul><ul><li>www.ebglaw.com in articles section </li></ul></ul>
  20. 20. Prolifiq for Life Sciences: Digital CMS with CHR <ul><ul><li>Maureen Shaffer </li></ul></ul><ul><ul><li>Vice President, Life Sciences Prolifiq </li></ul></ul><ul><li>(5 min) </li></ul>
  21. 21. Sales-Friendly Compliance
  22. 22. Simple, Powerful Rulebook
  23. 23. Robust Tracking and Monitoring
  24. 24. Questions & Answers <ul><li>Elsa Chi Abruzzo, President, ARAC </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><li>Steven Skwara, Partner, EBG </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><li>Sponsored by: </li></ul><ul><li>Maureen Shaffer, VP Life Sciences, Prolifiq </li></ul><ul><ul><li>[email_address] </li></ul></ul>

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