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ISPE (the International Society for Pharmaceutical Engineering) has announced its first European Annual Conference — Driving Effectiveness in Pharmaceutical Operations within the New Quality Culture, 28–30 April 2014, Sheraton Frankfurt Airport Hotel & Conference Centre, Frankfurt, Germany. This two-and-half-day event will bring together pharmaceutical, regulatory and technology experts from around the world.
The conference will consist of an executive forum, keynote sessions and three different tracks to assess how senior management, operational challenges, quality system effectiveness and regulatory changes can be brought into a new pharmaceutical paradigm to exploit opportunities like QbD, continuous manufacturing and science and risk-based regulations in daily operations. Additionally, the conference will discuss QRM in the industry as it relates to drug shortages as well as exploring technical advancements.
“One key benefit of this conference is the attendance of several regulators from various European authorities,” said Conference Chair Jean-Francois Duliere, Pharmaceutical Process Technologist, Technip Life Sciences, France. “Regulators are involved in nearly all stages of this conference, from providing input on track content to presenting during the conference and participating in each of the question and answer panels. Their involvement will provide valuable insights to conference delegates.”
Keynote speakers from industry and regulatory authorities will define the ‘New Quality Culture’ and share their perspectives on:
• the future of biopharmaceutical operations in a stronger competitive market
• current and future regulatory challenges, while ensuring control over manufacturing cost
• the most effective principles of managing quality and compliance and how they can be employed in the pharmaceutical industry
• the latest regulatory perspectives on the implementation of the new regulations, how regulators continue to work with the industry and the current changes to the regulatory framework.
The Executive Forum will offer pharmaceutical executives, senior experts and future decision makers a platform to interactively examine the current challenges in technical operations and dominant factors to achieving successful pharmaceutical manufacturing, namely safety, efficiency and compliance during development, transfer, production and distribution.