Investigational Products (IP):

Lean and Compliant? Applying Efficient Tools to a Regulated Clinical Supply Chain

Wednesday 22 September - Thursday 23 September

Seminar Content Level: Advanced

Seminar leaders: Massimo Eli, MSD, Italy; Bernd Steffens, Boehringer Ingelheim, Germany

This seminar helps delegates understand and develop new, lean and efficient ways along the supply chain for IMPs while being compliant with clinical trials regulations globally. Using case studies and real examples the focus will be on sharing experiences from the wide range of companies involved in all supply chain activities for investigational medicinal products.

The following topics will be amongst many covered during this highly interactive two-day seminar:

Regulatory speakers from EMA focusing on the GMP/GCP-interface
Unique opportunity to provide direct feedback to EMA on approaches agreed in one of the interactive workshops to discuss GCP/GMP
interface
VOC ‘Voice of the Customer’; Views and perceptions from a clinical site
Application of lean management tools
IVR – technology and validation
Using an ERP system to drive the clinical supply process
Managing and motivating clinical supply personnel

Take Back to Your Job:

Shared and developed experiences through workshops, networking and development of best practice solutions to real problems
State-of-the-art knowledge and understanding of issues facing IP professionals

Who Should Attend:

Those working in the fields of investigational products or clinical trials

Community of Practice (COP):

Investigational Products

Programme

Day 1, Wednesday 22 September

10.00 – 10.15 Welcome and Introduction
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)

10.15 – 11.00 Keynote Speech Part 1 GMP/GCP Interface
Rebecca Harrison, MHRA (UK)
Stay tuned for updated session information

11.00 – 11.45 Keynote Speech Part 2 GMP/GCP Interface
Philip Lange Møller, DKMA (Denmark)
Stay tuned for updated session information

11.45 – 13.00 Interactive Regulatory Forum

Break out into working groups
Topic: Feedback for EMA on what IP professionals should/could do differently tomorrow to better support GMP/GCP interface

13.00 – 14.00 Lunch and Networking Break

14.00 – 14.15 Summary Feedback from Interactive Regulatory Forum
Bernd Steffens, Boehringer Ingelheim (Germany)

14.15 – 15.00 Clinical Supply at the Sharp End! Views and Perceptions from a Clinical Site
Marloes Seesing, Genzym (NL)

How do hospital pharmacy departments manage clinical trials medication?
What are the current challenges for clinical trials pharmacists with trial medication?
What strategies can be employed to create – ‘an ideal clinical trial pack’ for the site and the patient?

15.00 – 15.45 Approach to Validation for IVR Systems
Robert Smith, Genzyme (UK)

Regulatory requirements for validation
Processes to follow
Case study/experience

15.45 – 16.15 Break

16.15 – 17.30 Introduction to Workshops
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)
Workshops - Group 1 (delegates choose only one workshop out of three)

Discussions on current regulatory topics including Annex 13
Robert Smith, Genzyme (UK); Sarbari Roy, Astra Zeneca (Sweden)
Comparator medication/ non IMPs – Task Team
Esther Sadler-Williams, Aptuit (UK)
Supply options for investigator sponsored studies
Peter Orosz, Boehringer Ingelheim (Germany)

17.30 – 17.45 Questions and Answers, Close of Day 1
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)

17.45 – 18.45 Exhibition Networking Reception

Day 2, Thursday 23 September

08.45 – 09.00 Introduction to Day 2, Audience Vote on Workshop Topics for Workshop Session 3
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)

09.00 – 09.15 Investigational Products – Communities of Practice
Christine Milligan, Chair of EU IP COP, Fisher (UK)

09.15 – 10.00 Implementing a Lean Mindset in CMC Clinical Supplies
Nicolas Omdahl, Novo Nordisk (Denmark)

How to drive the daily operations with a lean structure
How to stabilise processes and merge lean tools with quality systems
How to manage and improve the long term business performance

10.00 – 10.45 How to Establish a Demand and Operations Planning Process in the Clinical Supply Chain
Richard Lunney, GlaxoSmithKline (UK)

Comparing and contrasting the benefits of D&OP in a commercial supply chain with the needs of the clinical trial supply chain
The impact upon business processes, information systems and ways of working
The cultural change underpinning the introduction of a D&OP process
Managing the change process across the R&D supply chain
Case study (project example)

10.45 – 11.15 Break

11.15 – 12.30 Workshops - Group 2 (delegates choose only one workshop out of three)

Application of LSS in a Pharma and Contractor Environment
Dianne McLaughlin, Aptuit (UK); Nicolas Omdahl, Novo Nordisk (Denmark)
A Toolbox for Virtual Clinical Supply Organisation
Marianne Oth, Eli Lilly (Belgium)
Distribution Topic
Massimo Eli, MSD (Italy); Karen Gram, Novo Nordisk (Denmark)

12.30 – 13.30 Lunch and Networking Break

13.30 – 14.45 Workshops - Group 3

Choice of topics based on top three topics chosen by delegates at beginning of Day 2

14.45 – 15.30 Case Study - An ERP (SAP) Based Fully Integrated Solution to Plan, Control and Execute the Corporate Clinical Supply Chain
Ewald Kamp, Roche, Switzerland

Enrolment driven material demand forecasting
Regulatory and enrolment driven supply planning and distribution execution
Consolidated and fully integrated drug product manufacturing planning
Fully integrated patient kit production scheduling and execution including capacity planning and control

15.30 – 16.15 Wildcard/Panel Discussion
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)

16.15 – 16.30 Voting Session on Themes for 2011, Questions and Answers, Close of Seminar
Bernd Steffens, Boehringer Ingelheim (Germany); Massimo Eli, MSD (Italy)