1. Meredith Brown-Tuttle, RAC Director APT Pharmaceuticals, Inc.
The Tools of Regulatory Intelligence: Where to Start when Developing Regulatory Strategy or Answering a Question
Meredith Brown-Tuttle, RAC
Director
APT Pharmaceuticals, Inc.

2. Disclaimer
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3. What is Regulatory Intelligence
“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.”
DIA Regulatory SIAC, Regulatory Intelligence Working Group
Copyright 2009 Meredith Brown-Tuttle

4. What is Regulatory Information?
Can be oral, written, published, unpublished, etc.
Basic building blocks of intelligence, the raw information
Copyright 2009 Meredith Brown-Tuttle

5. Information vs. Intelligence
Intelligence is active and related to analysis and surveillance
Information is the raw data used to create intelligence
Copyright 2009 Meredith Brown-Tuttle

6. Regulatory Intelligence
RI allows a regulatory professional to
Create a strategy for a product
Create a development plan for product
Research past precedence and adjust for current regulatory climate
Advise personnel
Write or construct a marketing application incorporating all Agency requirements and
Adjust marketing application to ROW needs
Copyright 2009 Meredith Brown-Tuttle

7. Copyright 2009 Meredith Brown-Tuttle
Researching the Topic
Define your topic with key words or concepts such as:
transdermal patch validation batch
505(b)(2) done to date for analgesics
How to file a 505(b)(2)
How to file Canadian CTA, INN Name, etc.
How many products received fast track, priority review and received orphan designation
Don’t be afraid to use Google!
Copyright 2009 Meredith Brown-Tuttle

8. Copyright 2009 Meredith Brown-Tuttle
Researching the Topic
Use key terms as you would for a Medline search
If subject looking for is complex, break it down into a few key words to start with
Can do a “search within results” to further refine topic if too many “hits” are returned or if need to add more key words
Be willing to put the time in to drill down into documents
Do a search for terms on screen (control f)
Copyright 2009 Meredith Brown-Tuttle

9. Copyright 2009 Meredith Brown-Tuttle
Researching the Topic
Develop checklists for where to start for certain questions
Checklists are divided by clinical, nonclinical and CMC
Checklists give sources to start with so you make sure you check all available sources
Great to have on hand for training
Copyright 2009 Meredith Brown-Tuttle

10. Sources of Regulatory Intelligence
Common:
Regulations
Guidance Documents (preamble and comments)
Panel Meetings
Previous approvals
Less common
Interactions with reviewers
Warning Letters/Untitled Letters
Interactions with other regulatory professionals
FDA presentations
Competitor information
FOI requests
Compliance guides
MAPPs
Copyright 2009 Meredith Brown-Tuttle

11. More than Regulations and Guidance Documents
Regulations and guidance documents tell ½ the story.
These sources describe the black and white story … most of regulatory is gray!
Guidance may be waived
There might be no guidance at all
Interpretation of guidance varies with company and their experience
Copyright 2009 Meredith Brown-Tuttle

12. Regulatory Information
Finding regulatory information is not usually found in one location.
You need to have numerous sleuthing techniques in your armamentarium to be able to address the scope and breadth of questions posed to you
For each question put forth, there are numerous sources to begin your search
Copyright 2009 Meredith Brown-Tuttle

13. Sources of Regulatory Information
On-line professional and scientific article subscriptions
Regulatory agency Web sites
Previous regulatory submissions (internal to the company)
Competitor’s previous submissions
Competitor’s marketing literature
Specialized regulatory intelligence software
Copyright 2009 Meredith Brown-Tuttle

14. Sources of Regulatory Information
alerts
Educational conferences
Regulatory reference and information sites
Local chapter meetings of various organizations.
Colleagues
Business intelligence websites and databases
FDA Advisory Committee meeting minutes
Books
Consultants
Copyright 2009 Meredith Brown-Tuttle

15. Regulatory Information Databases
Provide the ability to conduct focused research and surveillance, some summarizing and integration
Provide daily or weekly updates
Some provide limited analysis of documents
Still need to do analysis of information and impact to current program/product
Allow for integration of regulations into SOPs
Copyright 2009 Meredith Brown-Tuttle

16. Regulatory Information Databases
80+ countries available out of 194 in the world
Country specific regulations provided in the local language (can translate for a fee)
Key word or full text searches by country of choice
Information structured logically by subject matter
Access to current, revoked and draft documentation/information
Expert summaries/Explanatory documents
Copyright 2009 Meredith Brown-Tuttle

17. Regulatory Information Databases
Explanatory documents that guide you through a country’s drug/device registration process
How to start a clinical trial
Maintenance of a clinical trial
Adverse Event Reporting
Scientific Advice
Orphan application
How to construct a marketing application
How to deal with variations or changes of marketed products
Copyright 2009 Meredith Brown-Tuttle

18. Transforming Information into Intelligence
Research topic and cull all pertinent information about your research topic from resources
Read pertinent information about the research topic
Write a summary of each piece of information once read
Pull together all pieces of information and analyze how they fit and impact each other
Write up your analysis
Copyright 2009 Meredith Brown-Tuttle

19. Transforming Information into Intelligence
Once you have summarized the information, you will need to put it in a standard format to integrate the current position and recent information to deliver information to your target audience
Target audience can be:
Regulatory department
Product team
General distribution to company as a whole
Management
Various departments
Copyright 2009 Meredith Brown-Tuttle

20. Transforming Information into Intelligence
Subject: CMC, Clinical, Safety, non-clinical, etc.
Regulations, directives, guidance documents…
Proposed or recently codified regulation/ directive/guidance document
Explanation of how recent information will affect current practice and proposed changes (if any) to current practices to comply or be in-line with new information
How will new information affect your target audience/team or strategy
Save/file for future use and don’t be afraid to update
Copyright 2009 Meredith Brown-Tuttle

21. Questions
Contact Information 21