1. Transforming Regulatory Processes: What Needs to Change and How to Do It  

2. The Need to Change
Regulatory is at the tip of the spear of realizing market potential and getting therapies to patients
Opportunity to enhance our operations:
Process adjustments
Technology centralization
Data consistency
Focus on operational learning
With adjustments, we can work smarter, not harder
So, with Regulatory’s responsibilities growing and becoming more complex, it’s clear we need to change the way we work
Reg’s is a real interesting position to address the evolving market dynamics
We’re at the tip of the spear, the bottom of the funnel.
Therefore we see everything we have the opportunity to identify areas for improvement
Theme of work smarter / not harder, we did an assessment at the end of 2015… challenges… inform our strategy… share them today and get your thoughts / ideas

3. Common Challenges: No Standardization or Centralized Tracking
Lack of Standardization
Impact
No consistent terminology or dictionary
No consistency of what to capture
No consistent ownership
No holistic view
Difficult to assess impacts due to changes
No input to process improvements
No Central Tracking
Let’s talk through challenges that we’ve observed and heard directly from your peers
Lack of standardization, or when we don’t refer to things in a common way (products information, how we define things like commitments vs. obligations vs queries), leads to a lack of traceability,
it is hard to do simple things; like respond the agency information requests; or know which products we currently have commitments to fulfill
When we work across decentralized systems, leads to lack of metrics
Can’t learn and improve
Product information
Regional differences in definition
E.g. EU views PSURs as Commitment, while US does not for Annual Rpts
Multiple systems
Multiple spreadsheets
No common processes

4. Common Challenge: Manual Processes
No automation
Reliance on and calls
Single point of contact
Volume of manual process
No automation? No workflows, no alerts…compliance becomes more difficult
Means we rely heavily on s or calls
Having single points of contact: Human foibles, e.g. delays when passing along correspondence
Gilead & MedCo examples
Manually maintaining a plan: struggle to keep current
Time consuming plannning & tracking

5. The Result: Data Black Hole
Lack of Visibility
No data summarization or reporting
Communication Breakdowns
Lack of info sharing across markets
So what does disjointed tech and processes lead to: lack of visibility and communication break downs…or…An information black hole
It ‘s difficult for information to be transparent when it’s buried in multiple. Redundant systems, captured in s, or worse in team member’s heads

6. Ideal State: A Holistic View with Clear Connections
Application Chronology for Restolar IND
So, let’s talk about an example of what we’re looking for…A simple concept that needs to be simple in practice
Looks simple, but the truth is that if someone were collating this manually, it would take days/weeks

7. Ideal State: Automation to Minimize Errors and Effort
Application Chronology for Restolar IND @
Alert
With automation – Commitment to a correspondence

8. Advanced Capabilities
How Do We Get There?
Laying a Foundation
Getting Started
Advanced Capabilities
Roles & responsibilities
Common definitions
Common systems
Working in a system
Clean consistent data
Automation
Reporting
Metrics
Traceability
101, 201, 301
crawl walk, run. This is not meant to be exhaustive, but rather practical
And Janine will continue with some of this

9. Lay the foundation: Roles & Responsibilities
Contributors
Owner
Everyone understands the need for…SOPs…
But we’ve heard that we sometimes do this only for major submissions… but do we have it for all high frequency processes
Initiator: Who initiates the update process for each type of change
PM: Establish planning and execution owner
Contributors: Make clear the expectation for each contributor
Partners: Grant access to contribute to RIM systems
Need to do this for all relevant processes.. Correspondence, commitments, queries
Lilly example
Project / SubmissionManager
Partners

10. Lay the Foundation: Common Definitions
What constitutes a …?
Who manages which type?
What needs to be tracked?
Another key foundation activity is defining the data you need to manage
Define the topic… and the metadata about it?
More of data that gets tracked against these
What gets reported on?

11. Lay the Foundation: Common Systems
Headquarters
Affiliates
External parties
Dictionaries used in Common systems
ones that provide global access and visibility
Business partners
Global / central use of systems

12. Getting Started: Prioritize Clean and Consistent Data
Usage of a standardized dictionary
Centralize / standardize data entry
Designate data owners responsible for quality
Establish a governance process for dictionary management
Now that we have our foundation / definitions…
Need to create and enforce use of standard dictionary for product and application information
Important for data quality; critical for reporting
Data Definition
Correspondence, commitment, and event tracking
Definition
What gets tracked
Who manages which types
Centralize data entry or standardize data entry forms
Governance process for dictionary mgmt
Create data owners responsible for data quality
Product Information
Study Information
Application
Manufacturer(s)
Submission
Vocabularies

13. Getting Started: Work Within a System
Internally Driven Events
Create regulatory events 
Define related activities
Assign ownership
Plan submissions
Develop deliverables
Track due dates
Link to HA correspondence
Finalize submissions
Reporting
New Application
Label change
Shelf life extension
Externally Driven Events
Making sure you’re processes are mapped out in your new foundation
Think of the Events your group has to deal with…
Additional information request
Incremental study request
Manufacturer problems

14. Getting Started: Automation
Calendaring
Workflows
Notifications
Commitment
Submission Plan !
Content placeholder
Up until just a couple of years ago we really had to do a lot of customizing of technologies to achieve automation
The aspects you want to consider…
Use calendaring to address Reporting Obligations (including annual reports) to set milestone dates
Tie calendar into plans and utilize workflows to automate process and ensure the business rules are being followed
Use Notifications to promote awareness…globally

15. Advanced Capabilities: Reporting
Submissions
Correspondence
Commitments
Content Plan
Progress
Deliverable Status
Track within and across applications
Which are open, closed, have due date approaching
Global
Registration Status
Local Market Activities
Calendar
Transitioning into ‘advanced’… once you’ve started executing processes on the new foundation, you can really build out your reporting sophistication.
Goal is to enable visibility into key information for appropriate parties
Start to link these together
Global visibility: View marketing status and registration details across your global product portfolio
Increased agility: Assess the impact of regulatory events and manage your response
Traceability from source doc to submitted output and corresponding registrations and commitments associated with each application.
Capture expected activities, submissions, and commitments
Report across related elements for global registration insights
Allocate work to local teams and track activities

16. Advanced Capabilities: Metrics
Document Status
Receipt dates
Due dates
Time to respond
Plan vs. actual
Region or area
Response targets
Record Count
Clinical
Non Clinical
Quality
Regulatory
Days until Planned Submission
Overdue Approval Tasks
Average Time to Approval
Learning & improving
One thing to report… another to gather insight
Improve across cycles
Dates
Receipt and delivery (receive and respond)
Plan vs Executed
Due Dates (by deliverable)
Overall time to respond
Submission/Response status
Deliverable Status
Region/owner/functional area, etc.
Response time targets (e.g. 10 days to respond to questions)
192
days
Documents Approved This Month 23
documents

17. Advanced Capabilities: Traceability
Creating relationships enables you to trace the impact of business changes.
A Manufacturing Process Changed: Now What?
CORRESPONDENCE
EVENT(S)
APPLICATION(S)
DOCUMENT(S)
ACTIVITIES
PRODUCT
When you’re running with a good tracking ability
Assess impact of business change
Establish traceability… why did respond to questions or commitments the way we did
SUBMISSION(S)
COMMITMENT(S)
REGISTRATION
CHANGE REQUESTS