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