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Pharmaceuticals in the Environment: A Regulatory Perspective (Session 306)

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Tuesday 8 November 08.15 – 11.30

ISPE CEUs: 0.23

Pharmaceuticals are bioactive chemicals with the potential to enter the environment through excretion from patients, discharge from manufacturing facilities, and disposal of unused medicines. Conventional waste water treatment facilities are not designed to completely remove these complex synthetic organic compounds. Active pharmaceutical ingredients have been detected in surveys of surface water and waste water discharges by university and government researchers within the United States, Europe and India. This resulted in a growing number of questions about the possible risks to humans and environmental species. The US EPA placed several active compounds on the Candidate Contaminants List to evaluate for regulatory control limits. Under the Water Framework Directive, the European Union also identified four pharmaceuticals for possible regulatory control. The Australian government has issued drinking water safety standards that include pharmaceutical residues. The World Health Organization investigated the need for establishing global safe drinking water limits. High residue levels found in surface water below waste water discharge facilities in India led Sweden to propose that the European Medicines Agency exercise control of discharge through GMP requirements. Attend this session to learn more about how investigations of pharmaceuticals in the environment could affect the pharmaceutical manufacturing industry.

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

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

  • Understand scientific, regulatory and public concerns about pharmaceuticals in the environment (worldwide)
  • Discuss the potential impact on the pharmaceutical manufacturing and development industry
  • Understand what manufacturing control and treatment technologies are effective

Who Should Attend

Facility engineers, Process engineers, Formulators, Environmental and safety staff, and QA/QC staff

Communities of Practice (COPs)

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

Containment