SEMINAR INFORMATION

Global Labeling Process Design and Evaluation

Good Labeling Process Practices - Evaluation - Auditing - Solutions

Next public seminar: Early Summer 2008 (tentative), Philadelphia

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

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

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

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