“We decided it was high time such a meeting of minds was held in Europe, particularly when globalization of the pharmaceutical industry continues at a rapid pace, the European Union has expanded to 25 countries and with the increasing influence of India and China on the international regulatory and manufacturing environment,” says Paul D’Eramo, Johnson & Johnson USA executive director and chair of the ISPE board of directors.
The event will include presentations, roundtable discussions, panel discussions and workshops. Issues planned for discussion will range from new regulatory initiatives to achieving international harmonization. In addition, there will be seminars for delegates to discuss the challenges and opportunities in future science-based active pharmaceutical ingredient manufacture, the GAMP Good Practice Guide for laboratory systems validation, planning strategies for the effective management of global investigational medicinal products supplies, maintenance of validated state, barrier isolation, and biopharmaceutical facilities.
For more information, visit www.ispe.org.
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