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

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

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

Common Challenge: Manual Processes No automation Reliance on email 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 emails 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

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 emails, or worse in team member’s heads

Ideal State: A Holistic View with Clear Connections Application Chronology for Restolar IND 0123456 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

Ideal State: Automation to Minimize Errors and Effort Application Chronology for Restolar IND 0123456 @ Alert With automation – Commitment to a correspondence

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

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

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?

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

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

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

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

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

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

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