Back to Basics: Transforming the Pharmaceutical Supply Chain PLENARY SESSION

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Back to Basics: Transforming the Pharmaceutical Supply Chain
Monday, 22 October, 2012
Leader: Jim McKiernan, CEO, McKiernan Associates, Switzerland – Roddy Martin, Senior Vice
President Global Supply Chain, Competitive Capabilities International, USA
PLENARY SESSION
09.00 – 09.30
Welcome and Introductions
Jim McKiernan, CEO, McKiernan Associates, Switzerland
09.30 – 10.10
Keynote Address
"EFFECTIVE SUPPLY CHAIN INTEGRITY THROUGH PROCESS IMPROVEMENT"
Heike Falkenhagen, PhD, Head of Global Quality Services, Boehringer Ingelheim, Germany
10.10 – 10.50
Keynote Address
"WHAT DOES GMP REALLY MEAN? The Focused Pursuit of Meeting Regulatory
Compliance Standards is really not Good Enough"
Ali Afnan, PhD, President, Step Change Pharma, USA
10.50 – 11.20
Networking Break
11.20 – 12.10
Keynote Address with Q&A
"THE IMPLICATIONS OF THE NEW FALSIFIED MEDICINES DIRECTIVE ON SUPPLY CHAIN"
Richard Andrews, GDP Operations Manager, MHRA, UK
12.10 – 12.30
Question & Answer with All Keynotes
12.30 – 14.00
Lunch
ENTERING A NEW ERA OF SUPPLY CHAIN
14.00 – 15.20
"Setting the Scene for Supply Chain Transformation"
Martin Roddy, Senior Vice President Global Supply Chain, Competitive Capabilities International,
USA
14.40 – 15.20
"The Role of Standards in Enforcing Process Validation"
Alex Viehmann, Operations Research Analyst, FDA, CDER, Office of Pharmaceutical Science,
USA
15.20 – 15.50
Networking Break
15.50 – 16.30
"How Well Connected is the Pharmaceutical Supply Network?"
Nick Davies, CEO & Principal Consultant, NDA Consultants, USA
16.30 – 17.00
Panel Discussion with Q & A
17.00-18.30
Networking Reception
Back to Basics: Transforming the Pharmaceutical Supply Chain
Tuesday, 23 October, 2012
Leader: Jim McKiernan, CEO, McKiernan Associates, Switzerland – Roddy Martin, Senior Vice
President Global Supply Chain, Competitive Capabilities International, USA
LESSONS FROM NON-PHARMA INDUSTRIES
09.00 – 09.45
“Learning from Other Industries – A Case Study on Capacity Sharing in Pharma
Aeneas Marxen, PhD, Consultant, PharmaCentaur,
09.45 – 10.30
“Leveraging Supply Chain Practices from Other Sectors to Improve Pharma’s”
Joseph Paris, Chairman, XONITEK Group Of Companies, USA
10.30 – 11.00
Networking Break
11.00 – 12.30
PHARMA CAFE
Facilitator and Topic
Roddy Martin - New directions in Supply Chain Strategy
Jim McKiernan - Reducing Working Capital Through Effective Supply Chain Strategies
Bryan Wright - Drug Shortages - Causes and Solutions
Ali Afnan - The Impact of Supply Chain Errors on the Patient
Additional Topics:
Impact of Supply Chain Pedigree, Facilitator Invited
Falsified Medicines Directive, Facilitator Invited
12.30 – 14.00
Lunch
ANTI-COUNTERFEITING & SUPPLY CHAIN INTEGRITY
14.00 – 14.45
Nia Evans, RP/QP, AAH, Celesio, UK
14.45 – 15.30
Drug Shortages
Invited Speaker: EMA-EU
15.30-16.00
Networking Break
16.00 – 17.00
Industry & Regulatory Panel
Moderator: Bryan Wright, ISPE Regulatory Advisor, UK Panel Members:
Richard Andrews, MHRA
Ali Afnan, StepChangePharma
Heike Falkenhagen, Boehringer Ingelheim
Alex Viehmann, FDA
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