1. 1 From Regulatory Intelligence to Compliance Debbie Henderson Head, Global Regulatory Policy EU Ring May 13, 2014

2. Ensure the company maintains worldwide compliance with regulatory policy requirements Need a formal process for demonstrating that the company: –Monitors published regulatory policies; –Assesses impact of new legislation or guidance (regulatory policy documents); –Makes changes as necessary to existing company procedures; –Creates new procedures as needed for new policies; and –Develops and provides staff training in new/modified procedures as needed Expectation It’s just good business 2

3. Scope Challenge: Global Coverage Where are the company’s business interests? What are the regional issues? What are the local (country) issues? How do you stay informed about new or modified policies? 3

4. Scope Challenge: Policy Topics DIA Labeling Biosimilars Manufacturing Clinical Trials Meta-analysis Multi-region Clinical Trials Data Sharing Transparency Ethics Regulatory Procedures Biomarkers Inspections Health Technology Assessment Pharmacovigilance Serialization Trademarks Track & Trace Vaccines Antibiotic Resistance Informatics Electronic Submissions ICH Innovation Packaging Drug Development Medical Devices Advertising & Promotion Toxicology Pediatrics Benefit Risk In Vitro Diagnostics Innovation Consumer Care/Over-the-Counter Drug Shortages Variations Abuse Liability Generics Social Media Rare Diseases Orphan Drugs Harmonization Data Standards Anti-Counterfeiting 4

5. Scope Challenge: Understanding Your Organization Who are the subject matter experts and points of contact? Who are the regional and country contacts? Who are the business process owners who can do the impact analysis? What is the chain of command for clearance of revised procedures? 5

6. Identify your trusted intelligence sources –Explore regulatory intelligence services (e.g., Cortellis) –Engage regional/country contacts to monitor health authorities’ activities to identify regulatory policy changes Develop business rules for filtering intelligence –Identify discrete subset that represents new policy Laws, decrees, regulations, guidelines, guidance, etc. –Identify regions/countries of interest –Identify scope of regulatory policy topics in business scope Developing Your Process 6

7. 7 Cortellis Regulatory Intelligence Weekly Alert HTML/unstructured text format Search functionality limited; sorting limited to by country as presented Average 300-400 document listings per week HTML/unstructured text format Search functionality limited; sorting limited to by country as presented Average 300-400 document listings per week

8. Compliance Weekly Alert 8 Macro converts to MS Excel format List filtered based on compliance business rules Range 50-100 document listings per week Easy sort and search capability by multiple categories (country, category, date, custom- defined) Macro converts to MS Excel format List filtered based on compliance business rules Range 50-100 document listings per week Easy sort and search capability by multiple categories (country, category, date, custom- defined)

9. Ensure resources available for consistent, real-time monitoring of intelligence sources Establish frequency (e.g., weekly) for generating report of newly published global policy documents Developing Your Process Regulatory Policy Compliance - Alerts 9

10. Document Your Process EXAMPLE Clarify roles and responsibilities –Use a “swim lane” approach Include steps for: Assessing potential business impact Potential for local or global impact Specify who (e.g., business process owner) makes the final determination regarding if a new or updated regulatory policy document requires compliance action Assigning document to business process owner for detailed impact analysis Maintain log of how each document was handled 10

11. Assess the regulatory policy Document actions deemed required per impact assessment Implement actions required Train relevant staff Communicate availability of modified or new business process Specify Expectations for Impact Assessment and Process Modification 11

12. Be prepared to demonstrate compliance by being able to produce: –Documented process –Intelligence sources –Tracking –Impact assessments –Training records –Modified business procedures –Communication to affected staff Demonstrating Compliance 12

13. Monitor process to ensure impact analysis and necessary process modifications are completed for each document Periodically evaluate the regulatory policy compliance process to ensure thoroughness, efficiency, accuracy Re-publish and retrain staff on the regulatory policy compliance process as needed Maintain the Regulatory Compliance Process! 13

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