Building a Core Labeling Process - Drug Information Association

Building a Core
Labeling Process
• Julie P. Retzinger RN, MBA
Baxter Healthcare Corporation
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Building a Core Labeling Process: Presentation Outline
• Resources: Establishing Management and Personnel
• Establishing Operating Mechanisms
• Electronic Tools
• The Communication Plan
• Sustainability
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Resources: Establishing Management and Personnel
• Experienced resources and management:
• Ideally y the working g teams will have health science backgrounds g
such as, RNs. Med Tech, PharmD. This is essential when
understanding the clinical environment, patient populations and
pharmacology of the drugs being represented in labeling
• Experience in drug development is also a valuable background
Will understand, how the safety and efficacy of a drug is
established from clinical data
• Need to feel the “duty to warn” or “ heart”, do what's right to
communicate to the patient and clinician the safety and efficacy
of the drug
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Establishing Operating Mechanisms: The Quality
Procedure/SOP
• Establish a GLOBAL SOP procedure to drive global labeling
harmonization
• It is recommended that e.g. Global RA, PV, Quality, and Clinical
personnel be trained on this procedure
• This procedure should clearly define the following processes:
– Creating, revising, reviewing/approving, and issuing of CCDS
– Authoring: RA, Quality, Clinical, PV
– Editorial control of the document
– Annual Review of document (Tie to PSUR activity if possible)
– IIssuance activity tiit ( (l logistics i ti of fdi distribution tib ti of fth the ddocument tiinternally) t ll )
– Global and regional personnel ( assessment of local labeling with the CCDS,
local labeling submission)
– Label harmonization activities at the local/regional level
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Establishing Operating Mechanisms: The Quality
Procedure/SOP
• Establishing internal authority:
– Creations of a Global Labeling Committee (GLC) and their Roles and
Responsibilities
• The (GLC) are senior-level decision makers that approve the CCDS
• Voting members may include: (example) Global Labeling
Chairperson, Global Regulatory Affairs, Global Pharmacovigilance,
European p UUnion QQualified Person for Pharmacovigilance g ( (EU- U
QPPV), Clinical Affairs, Preclinical/Toxicology, Corporate Law
Department, and Quality
• Typically Global Marketing is a non-voting member (at least for
safety decisions)
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Establishing Operating Mechanisms: The Quality
Procedure/SOP
• Examples of GLC Responsibilities:
– AApproving i new or revised i d CCDS content t t by b documenting d ti their th i approval l
in writing or electronically
– Assigning deadlines for local/regional labeling submissions
– Reviewing Key Country implementation of CCDS into labeling
• US, Canada, EU, Japan ( keeping an eye to label harmonization)
– Review performance of labeling implementation
– Reviewing overall performance of the labeling process/system
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Establishing Operating Mechanisms: The Quality
Procedure/SOP
• Consider establishment of Regional Coordinators Role
– Canada
– European Union
– Latin America
– Asia Pacific
• Roles and Responsibilities of the Regional Coordinator
– Assure accurate implementation of CCDS into country labeling
• Works with QPPV, Region Medical and PV
– Coordinate submission time lines with regional RA
– Responsible for tracking of submissions in their regions
– Works with local MOH on responses' back from labeling
submission
– Communicate country specific requirements
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Establishing Operating Mechanisms: The Company
Position
• Establish the format and style of your CCDS document
– Mandatory and non- non mandatory content
– Instructional text ( notes and comments that may assist with
implementation)
• Establish the companies position regarding the following
– Warnings and Precautions
– Establishment of ADRs both based on clinical trial experience
and post marketing, what is the company’s threshold
– Pregnancy and Lactation
– Drug interactions
– Class labeling
– Other
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Establishment of Operating Mechanisms : Scientific
Support for the Labeling submission
• Establishment of justifications documentation (e.g. in Clinical
Overview format)
– A separate document that supports all (mandatory) labeling
statements intended to be incorporated into local labeling
– This support is inclusive of clinical data, Pharmacovigilance data,
and peer reviewed literature.
– eCTD modular format is recommended (regions can cut and
paste into their own eCTD labeling submission
• Establishment of signal detection and regular meetings with
Pharmacovigilance
– How will the CCDS and labeling organization operate with the Pharmacovigilance
organization?
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Electronic Tools
• Document Management System
– Securityy
– Version Control
– Formats
– Workflows
• Proof- reading tool
– To verify absence and differences between documents if needed
• Issuance System
– Web based design (global accessibility)
– Password protected
• CCDS tracking tool
– Tracking of key milestones, submission to MOH, Approval of
labeling submission
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The Communication Plan
• “The single biggest problem in communication is the
illusion that it has taken place” place George Bernard Shaw
• Your SOP is not an effective communication tool to drive change and
acceptance of a process
• Interactive training is needed for all stake holders in the process
– Road show to all the region
– Testing of the participants’ knowledge of their roles and responsibilities
– Testing of implementation activities
• Regular meeting with the Regional Coordinators
• Regular meetings with Global Pharmacovigilance
– Attendance to Signal detection meetings
• Regular meeting regarding the IT tools and their functionality
• Communication of Labeling guidance's to the broader organization
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Sustainability
• Regulatory Labeling Intelligence
– Communicate your expertise in labeling to the broader organization
• Annual Plan communicated to the broader organization
– New CCDSs to be authored
– Annual Review
– Resource planning
– Financial planning: up coming labeling submission
• Constant review of processes and procedures for process
improvement
– Listening to regional concerns and suggestions
• Communicate the risk mitigation role of the labeling to the broader
organization
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Questions
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