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Thursday, 13 June 2013

09.00 - 09.20

Introductions and Announcements;
Overview & Meeting Objectives

Jim McKiernan, CEO, McKiernan Associates;
Esther Sadler-Wiliams, Catalent /  Chedia Abdelkafi, UCB
 

09.20 - 10.00

Keynote Presentation followed by Q&A Session
Responding to the challenges for highly responsive, integrated supply chains
Roddy Martin, Competitive Capabilities International -invited

10.00 - 10.40

Keynote Presentation followed by Q&A Session
An Expert Inspector's View on Current Challenges for GMP
Richard Andrews, 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 GCP Inspector Presentation:  GCP Implications for the Clinical Supply Chain; a Regulators Perspective
Jason Wakelin-Smith, MHRA
"What Does GMP Really Mean? The Focused Pursuit of Meeting Regulatory Compliance Standards is really not Good Enough"
Ali Afnan, Step Change Pharma –invited
12.05 - 12.30 Patient Survey – Interim Update
Christine Milligan, Fisher
12.30 - 13.30 Networking Lunch
13.30 - 14.45 Introduction to and Regulatory Forum Pharma Café
14.45 - 15.20 Experience With Managing Clinical Supplies from a Clinical Site Perspective
TBC

Technology Transfer:
Tech Transfer to CMOs


Anti-counterfeiting and Supply Chain Integrity:

Temperature Controlled - Case Study on Effective Management

Information Technology:
Continuous Manufacturing

15.20 - 15.50 Networking Break
15.50 - 17.00

Introduction to Workshops

Workshop A

Pharma Café
Technology Transfer:
Tech Transfer to CMO's

Anti-counterfeiting and Supply Chain Integrity:
Temperature Controlled - Case Study on Effective Management


Information Technology:
Continuous Manufacturing
17.00 Seminar Adjourns, Reception

 

Friday, 14 June 2013

  CLINICAL SUPPLY CHAIN COMMERCIAL SUPPLY CHAIN
09.00 - 09.10 Introductions and Summary of day 1;
Esther Sadler-Wiliams, Catalent
Chedia Abdelkafi, UCB
Introductions and Summary of day 1;
Jim McKiernan, CEO, McKiernan Associates
09.10 - 09.30 Introduction to ISPE and IP COP
Henryk Junker, Allergan
Introduction to ISPE and OM COP
Jim McKiernan, CEO, McKiernan Associates
09.30 - 10.10 Ensuring security of Clinical Supply Chain - Case Study
John Hyland, Mundipharma –invited
Effective Supply Chain Integrity through Process Improvement
Heike Falkenhagen PhD, Boehringer Ingelheim
10.10 - 10.50 Ensuring Consistency of Supply for Comparators
TBC
How Well Connected is the Pharmaceutical Supply Network?
Nick Davies, NDA Consultants –TBC
10.50 - 11.20 Networking Break
11.20 - 12.30 Workshop B Pharma Café

Technology Transfer:
Tech Transfer from R&D to Manufacturing

Anti-counterfeiting and Supply Chain Integrity:
Anti Counterfeiting


Information Technology:
Drug Shortages - Root, Causes and Solution
s

12.30 - 13.30 Networking Lunch
13.30 - 14.10

JIT Packaging and the Role of Pooling 

Helen Underwood, Fisher

Pharma Café
14.10 - 15.20 Workshop C

Technology Transfer:
Tech Transfer from R&D to Manufacturing

Anti-counterfeiting and Supply Chain Integrity:

Track and Trace


Information Technology:
Drug Shortages - Root, Causes and Solutions

15.20 - 15.50 Networking Break
15.50 - 16.00

Voting for themes for 2014,
IP Closing remarks

Pharma Café
16.00 - 16.40

What can Pharma learn from other industries?

16.40 - 17.00

Discussion and Closing remarks
Jim McKiernan, CEO, McKiernan Associates ;
Esther Sadler-Wiliams, Catalent /  Chedia Abdelkafi, UCB

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