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Conference Schedule

ISPE Supply Chain Conference Programme Leaders:

  • Esther Sadler-Williams & Chedia Abdelkafi, Investigational Products
  • Jim McKiernan, Supply Chain Integrity through Process Improvement

Thursday, 13 June 2013

09.00 - 09.20

Introductions and Announcements;
Overview & Meeting Objectives
Jim McKiernan, CEO, McKiernan Associates 
Esther Sadler-Wiliams, Senior Director, Catalent Pharma Solutions 
Chedia Abdelkafi, Head of Global CTS Planning, UCB Pharma
09.20 - 10.00

Keynote Presentation followed by Q&A Session
Responding to the Challenges for Highly Responsive, Integrated Supply Chains
Roddy Martin, Senior Vice President Supply Chain, Accenture USA
10.00 - 10.40

Keynote Presentation followed by Q&A Session
An Expert Inspector's View on Current Challenges for GMP
Richard Andrews, Exper GMP/GDP Inspector, MHRA
10.40 - 11.10 Networking Break
CLINICAL SUPPLY CHAIN COMMERCIAL SUPPLY CHAIN
11.10 - 11.25 Welcome and Introduction to Investigational Products Welcome and Introduction to Regulatory Supply Chain
11.25 - 12.05 Keynote Address: 'So What Exactly Happened To Your Shipment...?'
Jason Wakelin-Smith, GCP Inspector, MHRA

Keynote Address: 'What does GMP really Mean?' The Focused Pursuit of Meeting Regulatory Compliance Standards is really not Good Enough

Richard Andrews, Operations Manager, MHRA Brendan Cuddy,Scientific Administrator, EMA
12.05 - 12.30 Patient Survey - Interim Update
Christine Milligan, ISPE Patient Survey Team
12.30 - 13.30 Networking Break
13.30 - 13.45 Introduction and Regulatory Forum
Pharma Café Anti-counterfeiting and Supply Chain Integrity Seminars
13.30 - 14.10 Temperature Controlled - Case Study on Effective Management Marie Boned, Expert in health products cold chain, Cemafroid
14.10 - 14.50 Anti-counterfeiting
TBC
14.50 - 15.30 Track-and-Trace
Ulrike Kreysa, Vice-president Healthcare, GS1
13.45 - 15.20

Experience With Managing Clinical Supplies from a Clinical Site Perspective

Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Scotland
15.20 - 15.50 Networking Break
  15.30 - 16.00 Networking Break
15.50 - 17.00 Introduction to Workshops 

Workshop A

IRT standardisation from sponsor’s perspective of logistics & terminology, front end and site perspective
Nimer Yusef, Consultant, Trial-Brain
Michael Richter, GTC, Roche

Drug pooling and QP release - case Study and discussion
Henryk Junker, Quality Assurance Manager,Allergan 
Massimo Eli,  Merck &Co

Innovative Approaches to improve clinical supply chain for our users; the patient
Samantha Carmichael, NHS Scotland, Christine Milligan , ISPE Patient Survey Team
Pharma Café Information Technology Seminars
16.00 - 16.30

Drug Shortages - Root Causes and Solutions

Bryan Wright, ISPE European Regulatory Affairs Advisor
Technology Transfer Seminars
16.30 - 17.00 Technology Transfer to CMOs
TBC
17.00 - 17.30

Technology Transfer from R&D to Manufacturing

Paul Bird, Head of Development Engineering, Fujifilm




 
17.00 Seminar Adjourns, Reception
  17.30 Seminar Adjourns, Reception

 

Friday, 14 June 2013

08.30 - 08.40 Introductions
Esther Sadler-Wiliams, Catalent;
Jim McKiernan, CEO, McKiernan Associates 
08.40 - 09.25

Keynote Presentation
 

Industry Trends, and What can Pharma Learn from Other Industries?

Colin Terry, Senior Manager, Deloitte
CLINICAL SUPPLY CHAIN COMMERCIAL SUPPLY CHAIN
09.30 - 09.40

Introductions and Summary of
day 1 
 

Chedia Abdelkafi, Head of Global CTS Planning, UCB

Bernd Steffens, Head of Clinical Global Supplies Unit, Boehringer Ingelheim

 09.30 - 09.45 Introductions and Summary of
day 1
Jim McKiernan, CEO, McKiernan Associates
09.40 - 10.00 Introduction to ISPE and IP COP
Henryk Junker, Quality Assurance Manager, Allergan		 09.45 - 10.30 Effective Supply Chain Integrity through Process Improvement
Heike Falkenhagen, Boehringer Ingelheim
10.00 - 10.40 Ensuring Security of Clinical Supply Chain
Tom Cochrane, Business Process Development Manager, Napp
10.40 - 11.10 Networking Break
11.10 - 12.20

Workshop B

Use of English -only labels on inner packs

Hans Heesakkers, Senior Manager,Accenture

Karen Gram,Technical Lead, Novo Nordisk

 

Perils and Pitfalls of Comparator Supply

Julian  Schultz, Associate Director Clinical Supplies, Takeda

Robert Donnell, Head of Business Development, Durbin

 

Key Attributes of Simulation Tools

Damian McEntegart,Senior Director, Statistics & Product Support Services, Perceptive Informatics

Chedia Abdelkafi, Head of Global CTS Planning, UCB Pharma

 11.00 - 11.45

How Well Connected is the Pharmaceutical Supply Network?

Nick Davies, CEO & Principal Consultant, NDA Consultants
11.45 - 12.25 Temperature Controlled
TBC
12.20 - 13.20 Networking Break
13.20 - 14.00

JIT Packaging and the Role of Pooling – true flexible solutions or potential complexity drivers?

Helen Underwood, Client Services Director, Fisher

 13.15 - 13.55 Cargo Risk Assessment - Rx360 - Supply Chain Security
TBC
14.00 - 15.00 Workshop C 13.55 - 14.35

Risk Evaluation

N ia Evans, Head of Regulatory Affairs, Celesio –invited
15.00 - 15.15 Voting for themes for 2014,
IP Closing Remarks		 14.35 - 15.15

Track-and Trace – Serialisation

Fatma Taman, General Manager, Pharmavision
15.15 - 15.45 Networking Break
15.45 - 17.15

PLENARY SESSION:

 

Regulatory Speakers - Guidelines

Bryan Wright, ISPE Regulatory Advisor (Session Chair)

Tony Orme, Senior GDP Inspector, MHRA

Brendan Cuddy, Scientific Administrator, EMA UK

Richard Andrews, Expert GMP/GDP, MHRA
17.15 - 17.30

Discussion and Closing Remarks:

Jim McKiernan, CEO, McKiernan Associates

Bernd Steffens, Head of Clinical Global Supplies Unit, Boehringer Ingelheim

Chedia Abdelkafi, Head of Global CTS Planning, UCB Pharma

 

Thank you to our Top Tier Sponsors

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