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Pharmaceutical Manufacturing in Central and Eastern Europe (Session 502)

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Wednesday 9 November 08.15 – 12.00

ISPE CEUs: 0.35

This session looks at another option for companies looking to move their manufacturing away from the high cost facilities in the US and Western Europe, but unwilling to commit to building a facility in the Indian sub-continent or the Far East. Central and Eastern Europe (CEE) is a diverse region, comprising several, highly regulated member States of the European Union plus other countries where the pharmaceutical industry is less-regulated at present but is evolving rapidly. The session will provide an introduction to the CEE markets and discuss business challenges and opportunities relating to markets expansion and cost reduction. There will be regulatory overview of the CEE markets. Business expansion in the CEE will be demonstrated by the use of case studies.

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

How You Will Benefit

  • Understand the opportunities and challenges existing in the CEE market
  • Be aware of the regulatory environment in CEE, both in the EU member States and in the non-EU countries
  • Demonstrate through case studies the advantages to be gained from doing business in CEE

Who Should Attend

  • Pharmaceutical Executives
  • Quality Professionals
  • Project Managers
  • Operations Managers
  • Business Sponsors
  • Regulatory Affairs Professionals
  • Personnel from multinational, brand or generic companies with responsibilities or interests in CEE

Communities of Practice

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

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