ISPE Conference on Product and Process Quality

Investigational Products - Delivering Quality by Design

Wednesday 17- Thursday 18 September 2008
Manchester, United Kingdom

Seminar Leaders:
Christopher Bland, Novartis (Switzerland)
Esther Sadler-Williams, Aptuit (UK)

• Discover the future of Clinical Supplies
• Receive Regulatory updates
• Address efficiencies and improvements in Labelling Processes

Supporting those working with investigational products (IP) and clinical trials, this seminar will work with delegates to understand clinical trials regulations in Europe, and develop better ways of working in line with these regulations. Using case studies and real examples, the focus will be on sharing experiences from the wide range of companies involved in the manufacture, packaging and distribution of investigational medicinal products. Through networking events, interactive workshops, and seminar presentations led by key opinion leaders, including those from within our industry and clinical/hospital environments, this seminar provides a unique and valuable forum to challenge existing preconceptions, explore alternative approaches and to share “best practice” ideas.

The highly targeted presentations of this seminar will be attractive to delegates, as will the presence of MMHRA regulator Rachel Carmichael who will be providing a regulatory update. Keynote speaker Mike Arnold will by talking on the future of clinical supplies. He is well known throughout the industry and has successfully developed innovative ways of working with clinical supplies.

Take Back to Your Job:

• Understanding of IP and clinical trials regulations in Europe
• State-of-the-art knowledge and understanding of issues facing IP and clinical trials
• Case studies and real examples from industry leaders in investigational medicinal products
• Development of best practice solutions to real problems formulated through workshops and networking

Agenda

Wednesday, 17 September

Navigating the External Environment

08.45 – 09.00 Welcome and Introductions
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

09.00 – 09.50 Keynote Speaker- Future of Clinical Supplies
Mike Arnold, Pfizer (USA)

State of The World - Where We Are Today
What Might The Future Hold - It's a Small World After All
Preparing for The Inevitable
Vision for 2020

09.50 – 10.35 GMP Inspectors perspective - IMP manufacture
Rachel Carmichael, MHRA (UK)

Historical background
Current Regulatory status
Current Issues including GMP inspections – UK and overseas; findings from combined GMP / GCP inspections

10.35 - 11.00 Coffee and networking break

11.00 - 11.45 Working with China to Supply Clinical Trials
Anneli Bergqvist, AstraZeneca (Sweden)

Regulations affecting import of clinical supplies.
Process for supplying clinical studies, (global & registration) including comparators and timelines.
Challenges when working with China.
Case study

11.45 – 12.30 JIT Labelling within a Commercial Packaging Environment- Late-stage Customisation Strategy
Geoff Giles, PGM Consulting (UK)

Approaches to control end to late stage customisation
Benefits and challenges

12.30 – 13.30 Lunch and networking break

13.30 - 14.00 Retest Dating on EU supplies - Joint ISPE/PDA Task Team
Vincent Devereux, Eli Lilly (Belgium)

Regulatory framework
Objectives of the task team
Action plan and deliverables
Guidance document

14.00 – 14.15 Introduction to Workshops
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

14.15 - 15.15 Workshops: Session 1
Karen Gram, Novo Nordisk (Denmark); Mark Glass, Fisher (UK)

Regulatory workshop
Where and when should IVR be used? Internal vs. external and role of standardisation
Cold chain guidance document – overview

15.15 – 15.45 Coffee and networking break

15.45 – 16.45 Workshops: Session 2
Geoff Giles, PGM Consulting (UK); Doug Meyer, Aptuit (USA); Evelyn Ego, Bayer Schering (tbc); Bernd Steffen, Boehringer Ingelheim (tbc); Rob Pizzie, Schering Plough (tbc)

JIT labelling – learning from commercial experience
Role of IT in clinical supplies
How can clinical and clinical supplies work in harmony?

16.45 - 17.20 Wildcard Session: Interactive Voting

Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

17. 20 - 17.30 Selecting Workshop Topics for Day 2
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

17.30 Question and Answer Session - Chair’s Seminar Close, Day 1
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

17.30 – 18.30 Networking Reception
plus IP COP Networking Event (tbc)

Thursday, 18 September

Partnering for Quality

09.00 – 09.30 Introduction to IP COP
Massimo Eli, Chair of EU IP COP, Schering Plough (Italy)

Role of IP COP and what can it do for me?
Steering committee
How do I join?

09.30 – 10.15 Session 6: Simulation in Clinical Trials – a Case Study
Geurt-Paul Koning, Solvay (Netherlands)

10.15 – 10.45 Coffee and networking break

10.45 – 11.30 Bridge between Worlds- The cPharm Concept
Kaja Hederich, Bayer Schering (Germany); Neshad Sharma, Bayer Schering (Germany)

How to ensure a close and faithful liaison between clinical and clinical supplies
History behind the concept
Evolution of the best practice model
Advantages for both parties
Plan and vision for the future

11.30 – 12.30 Workshops: Session 3
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

3 options for this workshop will be decided by seminar delegates during the first day - the most popular choices will be offered during this session.

12.30 – 13.30 Lunch and networking break

13.30 – 14.15 Quality by Design for Clinical Supplies in Hospitals
Sue Scobie, Pharmaceutical Consultant – Medicines Management (UK)

How do hospital pharmacy departments manage clinical trials medication?
What are the current issues for clinical trials pharmacists
- the supply chain
- packaging and labelling
- documentation
What are the potential sources of medication error in this process?
What strategies can be employed to optimise safety?

14.15 – 14.30 Voting Session on Themes for 2009
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)

14.30 – 15.00 Questions and Answers - Chair’s Seminar Close
Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)


Conference Programme General Information Hotel Information Networking Evening Sponsorship Opportunities Table Top Exhibitions Download Brochure	ISPE Conference on Product and Process Quality Investigational Products - Delivering Quality by Design Wednesday 17- Thursday 18 September 2008 Manchester, United Kingdom Seminar Leaders: Christopher Bland, Novartis (Switzerland) Esther Sadler-Williams, Aptuit (UK) • Discover the future of Clinical Supplies • Receive Regulatory updates • Address efficiencies and improvements in Labelling Processes Supporting those working with investigational products (IP) and clinical trials, this seminar will work with delegates to understand clinical trials regulations in Europe, and develop better ways of working in line with these regulations. Using case studies and real examples, the focus will be on sharing experiences from the wide range of companies involved in the manufacture, packaging and distribution of investigational medicinal products. Through networking events, interactive workshops, and seminar presentations led by key opinion leaders, including those from within our industry and clinical/hospital environments, this seminar provides a unique and valuable forum to challenge existing preconceptions, explore alternative approaches and to share “best practice” ideas. The highly targeted presentations of this seminar will be attractive to delegates, as will the presence of MMHRA regulator Rachel Carmichael who will be providing a regulatory update. Keynote speaker Mike Arnold will by talking on the future of clinical supplies. He is well known throughout the industry and has successfully developed innovative ways of working with clinical supplies. Take Back to Your Job: • Understanding of IP and clinical trials regulations in Europe • State-of-the-art knowledge and understanding of issues facing IP and clinical trials • Case studies and real examples from industry leaders in investigational medicinal products • Development of best practice solutions to real problems formulated through workshops and networking Agenda Wednesday, 17 September Navigating the External Environment 08.45 – 09.00 Welcome and Introductions Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 09.00 – 09.50 Keynote Speaker- Future of Clinical Supplies Mike Arnold, Pfizer (USA) State of The World - Where We Are Today What Might The Future Hold - It's a Small World After All Preparing for The Inevitable Vision for 2020 09.50 – 10.35 GMP Inspectors perspective - IMP manufacture Rachel Carmichael, MHRA (UK) Historical background Current Regulatory status Current Issues including GMP inspections – UK and overseas; findings from combined GMP / GCP inspections 10.35 - 11.00 Coffee and networking break 11.00 - 11.45 Working with China to Supply Clinical Trials Anneli Bergqvist, AstraZeneca (Sweden) Regulations affecting import of clinical supplies. Process for supplying clinical studies, (global & registration) including comparators and timelines. Challenges when working with China. Case study 11.45 – 12.30 JIT Labelling within a Commercial Packaging Environment- Late-stage Customisation Strategy Geoff Giles, PGM Consulting (UK) Approaches to control end to late stage customisation Benefits and challenges 12.30 – 13.30 Lunch and networking break 13.30 - 14.00 Retest Dating on EU supplies - Joint ISPE/PDA Task Team Vincent Devereux, Eli Lilly (Belgium) Regulatory framework Objectives of the task team Action plan and deliverables Guidance document 14.00 – 14.15 Introduction to Workshops Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 14.15 - 15.15 Workshops: Session 1 Karen Gram, Novo Nordisk (Denmark); Mark Glass, Fisher (UK) Regulatory workshop Where and when should IVR be used? Internal vs. external and role of standardisation Cold chain guidance document – overview 15.15 – 15.45 Coffee and networking break 15.45 – 16.45 Workshops: Session 2 Geoff Giles, PGM Consulting (UK); Doug Meyer, Aptuit (USA); Evelyn Ego, Bayer Schering (tbc); Bernd Steffen, Boehringer Ingelheim (tbc); Rob Pizzie, Schering Plough (tbc) JIT labelling – learning from commercial experience Role of IT in clinical supplies How can clinical and clinical supplies work in harmony? 16.45 - 17.20 Wildcard Session: Interactive Voting Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 17. 20 - 17.30 Selecting Workshop Topics for Day 2 Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 17.30 Question and Answer Session - Chair’s Seminar Close, Day 1 Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 17.30 – 18.30 Networking Reception plus IP COP Networking Event (tbc) Thursday, 18 September Partnering for Quality 09.00 – 09.30 Introduction to IP COP Massimo Eli, Chair of EU IP COP, Schering Plough (Italy) Role of IP COP and what can it do for me? Steering committee How do I join? 09.30 – 10.15 Session 6: Simulation in Clinical Trials – a Case Study Geurt-Paul Koning, Solvay (Netherlands) 10.15 – 10.45 Coffee and networking break 10.45 – 11.30 Bridge between Worlds- The cPharm Concept Kaja Hederich, Bayer Schering (Germany); Neshad Sharma, Bayer Schering (Germany) How to ensure a close and faithful liaison between clinical and clinical supplies History behind the concept Evolution of the best practice model Advantages for both parties Plan and vision for the future 11.30 – 12.30 Workshops: Session 3 Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 3 options for this workshop will be decided by seminar delegates during the first day - the most popular choices will be offered during this session. 12.30 – 13.30 Lunch and networking break 13.30 – 14.15 Quality by Design for Clinical Supplies in Hospitals Sue Scobie, Pharmaceutical Consultant – Medicines Management (UK) How do hospital pharmacy departments manage clinical trials medication? What are the current issues for clinical trials pharmacists the supply chain packaging and labelling documentation What are the potential sources of medication error in this process? What strategies can be employed to optimise safety? 14.15 – 14.30 Voting Session on Themes for 2009 Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK) 14.30 – 15.00 Questions and Answers - Chair’s Seminar Close Christopher Bland, Novartis (Switzerland); Esther Sadler-Williams, Aptuit (UK)