Streamlining a Global Life Sciences Company's Pharmacovigilance Operations

Facilitating Globalization with a standard approach to process reengineering

July 18, 2012

Rodney Lemery, MPH, PhD
Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc.

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Agenda
Summary of Situation
Project Overview Review of Current State

Description of Methods Used

Origin of Methodology Techniques Used

Results of Methods Lessons Learned What This Means for You

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Summary of Situation
Project Overview
A leading U.S.-based pharmaceutical company founded in the early 1980s issued a RFP asking for assistance in the globalization of their current Argus Safety system The company would be integrating three separate non-Argus safety applications into their central Argus database To accommodate this, procedures and work instructions not currently representing a global environment required analysis and updates to prepare the company for the use of the application in this new paradigm

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Summary of Situation
Process Overview

Companys acquisition of a global generics company resulted in the need to incorporate international case management, local labeling and other globalization aspects of process into their existing drug safety quality system
0 Policies 10 Procedures 4 Work Instructions

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Summary of Situation
Current State

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Summary of Situation
Client Needs
Update of global procedures governing non-Argus systems

into Argus specific documents Consolidation of all country specific procedures and work instructions into a more global process

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Methods Used

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Methods Used
Origin of Methods
Process re-engineering methods are diverse and range from

the simple to the complex Recent research has shown that the use of the Strengths, Opportunities, Weaknesses and Threats (SWOT) analysis is a powerful tool in strategic planning and process initiatives (Helms and Nixon, 2010)
Well entrenched in peer-reviewed journals
Used beyond strategic planning Time tested

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Methods Used
Origin of Methods
In order to facilitate accountability in the process improvement

initiative, BioPharm use a tool referred to as a RACI Diagram (Costello, 2012)

Responsible Accountable/Approve Consulted Informed

BioPharm has also determined that the SWOT report can easily

be transformed into a gap analysis summary In turn the gap analysis provides traceability to a strategic mitigation plan (road map) for the identified gaps
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Methods Used

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Techniques Used
RACI Table Produced
Project management literature (Costello, 2012) describes the importance of clearly documenting and communicating the expectations around deliverables for a given project BioPharm has found that using a tool referred to as a RACI table, to be an effective tool facilitating agreement of scope and responsibility

Identification of business unit resources and responsibilities Identify all anticipated deliverables Meeting to cover scope of process re-engineering tasks and agree on both scope and responsibility

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Techniques Used
Preliminary RACI for Anticipated Work

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Techniques Used

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Techniques Used
Desired Quality System
Determine Standard Quality System
BioPharm used our understanding of the global regulatory reporting environment and the Argus application to identify a set of quality standards needed to operate the Argus application in this context.

Agree upon standard

A meeting of all vested parties occurred to review the standard and agree
Removal of policy creation/modification from scope

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Techniques Used
Desired Quality System

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Techniques Used
Current Quality System
Deliver quality documents to BioPharm
The documentation was organized into a typical quality system hierarchy

Organize quality documentation

Each quality document was placed into the agreed upon standard quality framework
Policy to Policy, SOP to SOP and WI to WI

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Techniques Used
SWOT Analysis
Conduct SWOT against Desired State
BioPharm conducted a standard Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis on the quality documents compared to the agreed upon desired framework

Consensus Building
A meeting to review the SWOT analysis results will occur to gain consensus and understanding among the business units

Extract the gaps from any Weaknesses or Threats

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Techniques Used
SWOT Analysis Example

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Techniques Used
Further Analysis (optional)
Conduct Review of Inter-Unit Documents
Related business unit quality documents can also be compared to one another in tabular form and used to facilitate the discussion of issues among the quality documents that need to be harmonized

Consensus Building
A meeting to review the analysis results will occur to gain consensus and understanding among the business units

Extract the gaps from any Weaknesses or Threats

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Techniques Used
Further Analysis Example

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Techniques Used
Gap Analysis (Road Map Report)

Document gaps in quality documentation Ensure that each existing Strength and appropriate Opportunities are represented and recognized in the resulting gap mitigation

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Techniques Used

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Techniques Used
RACI for Agreed Upon Work

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Techniques Used
Quality Documentation Creation
BioPharm created a number of updates to these documents and facilitated numerous meetings to reach consensus on the practices of the safety team Iterative and interactive meetings were scheduled using WebEx to facilitate a spirit of collaboration

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Results
Impact on Globalization

Expanded the US-Centric WI into 8 Global WI appropriate to Argus Reduced 10 Procedures into 2 Updated US-Centric procedures and WI to include comprehensive global language (strengths and opportunities were vital in this effort) Identified a number of Argus configurations required to meet global needs
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Lessons Learned
The collection of quality documentation is important and

accurate, comprehensive and timely delivery for analysis was critical The use of the gap analysis report as a tool for project focus and effort is vital Iterative and interactive meetings aid in the fostering of ownership (of the quality documents ) to the appropriate department participants Global participation is often divergent and difficult; it is still crucial to ensure all vested parties are heard and their procedural needs are addressed

MS Word comment fields were used to annotate these needs

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Lessons Learned
Even after all of the consolidation meetings occur,

business procedures may differ too widely among the business units
Consolidation should be a goal not a finite rule
Possible that consolidation occurs only at the policy and

procedure levels not at the departmental/work instruction level

Local labeling work instructions, competent authority reporting etc.

Procedural work often identifies system level

configuration needs
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What this means for you?

Ways to Engage
For those ready
Proof of concept or scope discussions to see if this method would fit your needs

For those not quite ready

Schedule early engagement calls to provide guidance on similar projects

For those in the midst of a process re-engineering

Refine your approach with guidance calls to review your approach and evaluate if BioPharms methods might be useful to your organization

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References
Helms, M. M., Nixon, J. (2010). Exploring SWOT analysis where are we now?: A review of academic research from the last decade. Journal of Strategy and Management, 3(3) pp.215 251 Costello, T. (2012). RACI; Getting Projects Unstuck. IT Professional, 14(2), pp. 62-64

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Questions & Answers / Contact Information

Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance +1 650 292 5310 (U.S.) rlemery@biopharm.com Rod Roderick Vice President of Business Development +1 877 654 0033 (U.S.) rroderick@biopharm.com Rudolf Coetzee Director of Business Development, EMEA +44 (0) 1865 910200 (U.K.) rcoetzee@biopharm.com For more information about our offerings, you can reach any team member above or email info@biopharm.com.
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