Global Labeling Process Design & Evaluation
Overview
- 2-Day seminar
- For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC
Target Audience
- Labeling/regulatory professionals
- Labeling auditors and other QA professionals
- Pharmacovigilance professionals
- Clinical/medical professionals
- Law department members
- Brief Program Outline
Agenda
The following outline is a sample only and the actual seminar may differ.
Day 1
7:30 Registration and Breakfast
8:00 Instructor’s welcome, introduction of participants
8:30 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
- 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
- Characteristics of an ideal global labeling system – High level
- Good real-world systems: Priorities, compromises, trade-offs
- Breakout Group Work A
10:00 Break
10:15 Generic Process and System Structure
- Essential process steps at Headquarters-level, Affiliate-level, Supply Chain-level
- Company-internal reference information (CCDS, CCSI, DCSI etc) · Decision making structures
- Interface with the safety evaluation process
- Interface with CMC-related processes
- Tracking and auditing system modules
- Tools (templates, data bases etc.)
- Essentials and nice-to-haves for companies with a small number of products
- Breakout Group Work B
12:15 Lunch break
1:00 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? · Optimizing the structure of a Company Core Data Sheet
- Licensee/licensor collaboration issues
- Resources, prioritization and reward systems
3:15 Break
3:30 How to Monitor and Diagnose the Condition of a Labeling System – Part I
- Ways of gathering information on system status and performance · Complementary approaches: Output measures, tracking, auditing
- Symptoms, causes and root causes; Failure Mode Effects Analysis (FMEA)
- What to measure, track, audit – and how intensely
- System elements that can be easily evaluated/monitored using a Six Sigma-like approach
- From status and performance data to effective interventions/improvements
- Tools to support system monitoring
- Can we measure/evaluate labeling content quality?
- Breakout Group Work C
5:15 End of Day One
Day 2
8:00 Breakfast
8:30 How to Monitor and Diagnose the Condition of a Labeling System – Part II
- Auditing to verify/enforce compliance with an established system
- Auditing to identify the need for necessary system improvements
- How much, how often, and what
- From observation to corrective action and closure
- Audit strategies: Initial roll-out and maintenance auditing
- Breakout Group Work D
10:15 Break
10:45 Case Study
- Identifying the root cause(s) of what seems to be reluctance to implement a Core Data Sheets updates
- Deciding on the most effective measures to improve the situation
- Breakout Group Work E
12:15 Lunch break
1:15 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
- Breakout Group Work F
2:45 Break
3:00 System Design and improvement (continued)
4:00 Workshop Wrap-Up and General Q&A
4:30 End of Workshop