Transforming Your Clinical Supply Chain: Finding Your Golden Gate (Part 3)

Session 7003
Investigational Products Track

Conducting global clinical trials creates numerous challenges for the clinical trial material professional.

Track Description

Gain insight into the regulatory requirements for the key clinical development countries, Brazil, Russia, India and China and how to manage these requirements. The program will also provide “real life” solutions for the proper planning of clinical supplies for these key countries and managing the global supply chain.

Topics will include:

Regulatory Requirements for BRIC Countries + Japan
Product value determination (impact on duty, VAT, commercial)
Good Distribution Practices (GDP Document)
IRT - Smarter use for predictive analysis; More intelligent use of IRT

Workshop topics will include:

Building a Supply Chain around a Protocol - How best to use Forecasting Tool options
Tour of a Biotech manufacturing facility

At the conclusion of this track, participants will be able to:

Learn the benefits and risks of strategically going into emerging or new markets
Forecast and manage clinical supplies
Employ solutions and suggestions to mitigate challenges and duty implications faced in importing clinical supplies
Optimize the client-vendor relationship
Advance your supply chain capabilities and performance

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom