1. Linda Bowen Regulatory Intelligence sanofi-aventis
The Role that Regulatory Intelligence plays in a Highly Regulated Environment
Linda Bowen
Regulatory Intelligence
sanofi-aventis

2. Disclaimer
The views expressed in this presentation are the personal views of the author and do not necessarily represent the views of sanofi-aventis.

3. Presentation Highlights
Definition of Regulatory Intelligence
The Regulatory Intelligence Process
A survey of RI functions
Regulatory Intelligence as an integral and strategic part of the RA Department
Regulatory Intelligence – a small company perspective

4. Definition
Regulatory Intelligence is the act of gathering and analyzing publicly available regulatory information.  This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.
Ref: Regulatory Intelligence Network Group, DIA RA SIAC

5. What we’re not
Competitive Intelligence - the legal and ethical collection and analysis of information regarding the capabilities, vulnerabilities, and intentions of business competitors (ref: Society of Competitive Intelligence Professionals - SCIP)
Business Intelligence - business management term, which refers to applications and technologies that are used to gather, provide access to, and analyze data and information about company operations. Business intelligence systems can help companies have a more comprehensive knowledge of the factors affecting their business, such as metrics on sales, production, internal operations, and they can help companies to make better business decisions (ref: Wikipedia)

6. Basic requirements for a Regulatory Intelligence Employee?
5+ years RA experience
Scientific background
Knowledge of regulatory processes
Analytical thinking
Excellent communication and presentation skills
Forward looking
Prior interactions with health authorities
A true detective!

7. Recent RA employment opportunity
Consulting Company, “Regulatory Intelligence and training – Utilizes regulatory intelligence database(s) and other regulatory compliance resources; collates, summarizes and distributes regular regulatory intelligence updates relevant to the regions, regulatory agencies (such as FDA, EMEA, MHRA, etc), and therapeutic areas applicable to xxxxxx projects worldwide. Assists in the identification, development and delivery of regulatory compliance or country start up submission process related training for associates internally. Build a network of regional Regulatory experts (Vendors or Freelance/Contractors).”

8. Recent RA employment opportunity
Our Regulatory Affairs Professionals regularly demonstrate proven results in:
-Preparation, submission and maintenance of applications (NDA, BLA, ANDA, IND) for both NCE and biologics, manufacturing changes, supplements and labeling revisions
-Preparation of high quality, detailed regulatory documents using varied information sources
-Compilation of relevant documentation to allow release of products -Assisting in the preparation and submission of regulatory applications
-Collection of submission data and regulatory intelligence

9. Recent RA employment opportunity
The Vice President (Senior Director) will provide leadership and management of Regulatory Affairs activities and staff by:
Serving as liaison with FDA on regulatory submissions for product lifecycle on behalf of clients and performing IND maintenance and reporting requirements as needed
Actively participating in and providing leadership and oversight for the preparation, assembly and review of high quality documents for submission to regulatory agencies, including IND sections and technical reports
Providing regulatory strategy and intelligence for due diligence and other corporate issues with full awareness and guidance from current regulations

10. Recent RA employment opportunity
The Associate Director, RA will play a pivotal role in the organization strategy and the successful execution of the following
Develop, implement and execute regulatory strategic plans and best practices
Provides regulatory guidance for top-level project development (core teams)
Communicates with the senior leadership team regarding any concerns and/or obstacles in achieving desired result
Plays a key role in working with the FDA and other regulatory authorities in providing information, soliciting guidance and support for complex submissions
Research and develops regulatory intelligence concerning competitor products

11. The Regulatory Intelligence Function AKA
Regulatory Information and Intelligence
Regulatory Intelligence/FDA Liaison
Scientific Information
Regulatory Intelligence and Policy
Regulatory Strategist
Global Regulatory Sciences Informatics
Scientific and Regulatory Intelligence
Policy, Intelligence and Education
Reference Librarian

12. The Regulatory Intelligence Function
A dedicated Regulatory Intelligence group does not exist in most companies.
When it does exist as a structured function, the group can range in size from one person – often a reference librarian - to a large global group aligned by therapeutic area, products, projects and/or regions.
All companies conduct regulatory intelligence which at a minimum is limited to keeping themselves up-to-date on the latest regulatory, and perhaps even legislative, developments.

13. Regulatory Intelligence Tools
RI tools include:
Regulatory Intelligence Databases
Regulatory Alerts/Updates
Health Authority websites
Industry/Professional Assoc. websites
Professional journals
Newsletters
Business Intelligence Services
Discussion Groups/Forums/Blogs
Consultants
Colleagues

14. Regulatory Intelligence Tools
One of the most important RI skills you can develop is……..
NETWORKING
Within your department, company, working groups
and at trade/industry/professional association
meetings.

15. The Regulatory Intelligence Process
So that’s where you found it!
Courtesy of Meredith Brown-Tuttle

16. What does a structured regulatory intelligence function encompass?
Services often include:
News
Commenting/Consultation Process
Search and Analysis
Building Strategies
Knowledge Management

17. A Survey of RI Functions - News
Distribution of news via
Distribution of news via newsletter
Distribution of news via or newsletter with analysis and impact statement for group*
Distribution of news with analysis and impact via workshops or seminars
Scheduled reports (monthly, quarterly, yearly)
*Important to archive for future reference

18. A Survey of RI Functions - News
Discussion Topics:
Organizational changes within HA
Performance indicators
Draft and finalized policies, guidances, regulations
Product approvals
Product changes (CMC, new indications, safety)
Registration Procedures

19. A Survey of RI Functions - News
Discussion Topics:
Clinical – IRB, Informed Consent
CMC/Quality Issues
GXP Trends
Advisory Committee Broadcast (US)
Pending legislation
Hot Topics

20. A Survey of RI Functions - Comments
Coordination of the internal commenting process for draft guidances and regulations
Identify experts
Track the progress
Send in the response
Archive the data
Maintain repository
Does the final guidance include your comments?

21. A Survey of RI Functions – Search and Analysis
In-depth analysis upon request
Provide trends
Advisory Committee profiles (US)
Freedom Of Information requests (US)
Approval packages
Inspection reports

22. A Survey of RI Functions - Strategies
Help build development strategies by looking at:
Regulatory profiles of Competitor products
Competitor’s labeling
Company Press Releases
Registration procedures and Approval trends
Review division/Reviewer profiles

23. A Survey of RI Functions - Strategies
Strategies developed today are a snapshot of the current regulatory, scientific, and legislative environment.
Importance of lifecycle management when new or revised laws/regulations, guidances or scientific data present themselves

24. A Survey of RI Functions - Strategies
Regulatory strategy incorporates a drug development plan, an issue, background information, regulations/guidances/policies, strategic advice and recommendations on how to move forward.

25. A Survey of RI Functions – knowledge management
Develop and maintain RI database
Hot Topics Updates
Internal regulatory workshops
Conference participation
Regulatory Library; Approvals, AC briefing packages, transcripts, videos, external course notes

26. Regulatory Intelligence as an Integral Part of the Regulatory Affairs Function
Who will be your internal customers?
Global Regulatory Affairs Global Marketing
Drug Discovery Global Medical Affairs
Drug Development Public Affairs
Affiliates Government Relations
Global Pharmacovigilance Compliance
Clinical Operations Competitive Intelligence
Legal Business Intelligence

27. Large versus small
Large companies normally have the resources (people and tools) and are proactive
Smaller companies are usually reactive, investigating when asked a question. Searches may not be as exhaustive or extensive and the information may be lost if not archived properly.

28. The logistics of RI in a small company
Who will be conducting surveillance?
Information should be consolidated and maintained by one person
A dedicated database should be developed
Information should be entered in a uniform manner
Read only access for others

29. Small company surveillance
Know what direction your company is headed. This will drive future strategy and will help anticipate needs
Rely on Regulatory Intelligence databases for updates (especially global)
If the cost of a database is prohibitive, depend on free or low cost resources ( alerts, newsletters, professional journals) or even consultants
Tap into trade groups

30. Small company surveillance
Develop a network (colleagues, professional associations)
Volunteer (RAPS, DIA working groups, local RAPS chapters, RAC study groups)
Although tedious, the What’s New Section of Health Authority sites provides a wealth of free, up-to-date information
As regulatory evolves, so should you!

31. How to disseminate the information in a small company environment
Identify your target audience
What do they find important?
How does your target audience learn?
When does your target audience want the information?
Prioritize the risks or upcoming challenges based on new legislative or regulatory requirements

32. Make an Impact
Summarize Analyze Interpret Integrate

33. Acknowledgements
Special thanks to the members of the DIA Regulatory Affairs SIAC Regulatory Intelligence Working Group, especially Meredith Brown-Tuttle and Tom Perrone, for their insight on RI in a small company environment.