SEMINAR INFORMATION

Global Labeling Process Design and Evaluation

Good Labeling Process Practices - Evaluation - Auditing - Solutions

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1-Day seminar
For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC

Basic Characteristics and Functions of a Global Labeling System

Scope and elements of a global labeling system
What makes a global labeling system so special?
Dependence on corporate structure and culture
Necessary levels of headquarters control over Affiliate and Supply Chain actions
Quality mechanisms
Connections to the system of licensees/licensors
Interfaces with other change control systems
Coordination with the safety evaluation system and drug development activities

Effective Use of Company Core Data Sheets (CCDS) and Core Safety Information (CSI)

Technical features of a good CCDS/CSI
Macro- and micro-structure of CCDS/CSI
How to organize and archive core labeling decisions and supporting documentation
CCDS/CSI for "old products" compared to "new products"
When to update CSI, and how to avoid overwhelming local Affiliates with unnecessary labeling changes

Generic Process and System Structure

Essential process steps at Headquarters-level, Affiliate-level, Supply Chain-level
Decision making structures
Optimizing the interface with the safety evaluation process
Interface with CMC-related processes
Verification of local implementation, tracking and auditing
Tools (templates, data bases etc.)
Essentials and nice-to-haves for companies with a small number of products

Areas for Particular Attention

Labeling content quality; global and local labeling expertise; importance of supporting documentation
Content consistency – across products, markets
Quality, speed, efficiency and costs
System elements to ensure integrity
Bureaucracy, lack of flexibility
Committees: Size, composition, experience, empowerment; oligo-disciplinary bias
Hand-overs, ownership, responsibilities, accountability
Who should be permitted to trigger the decision making process?
Licensee/licensor collaboration issues
Resources, prioritization and reward systems

System Design and Improvement

Transformational change or evolutionary change
Avoiding damage caused by system evaluation and insensitive motivation
The limitations of company-to-company system comparisons and benchmarking studies
Do we need a labeling group? Which department should be responsible for global labeling?
System features to prevent "things from falling through the cracks" · System features to ensure expediency
System features to ensure consistency in labeling content decisions (inter-product, over time, development to postmarketing)
System features to ensure sustained expertise of decision makers · Within-system and cross-system coordination and prioritization to ensure appropriate resources
System monitoring and control
Training strategies