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首页> 外文期刊>Drugs of today: Medicamentos de actualidad >GENERIC PHARMACEUTICAL ASSOCIATION (GPHA)-2015 ANNUAL MEETING (FEBRUARY 9-11, 2015-MIAMI BEACH, FLORIDA, USA)
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GENERIC PHARMACEUTICAL ASSOCIATION (GPHA)-2015 ANNUAL MEETING (FEBRUARY 9-11, 2015-MIAMI BEACH, FLORIDA, USA)

机译:通用药品协会(GPHA)-2015年度会议(2015年2月9日至11日,美国佛罗里达州迈阿密海滩)

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摘要

The Generic Pharmaceutical Association (GPhA) chairman Craig Wheeler (Momenta Pharmaceuticals), welcomed attendees to the 2075 Annual Meeting by reflecting on the contributions of the generic industry over the post year and some of the challenges that lie ahead. In 2074, 86% of prescriptions dispensed in the U.S. were generic, contributing to the USD 7.4 trillion savings generated by the industry since its inception; however, there are still many challenges to face, including consolidation of customers, lag in Abbreviated New Drug Application (ANDA) approval timelines, restrictive Risk Evaluation and Mitigation Strategy (REMS) programs and labeling legislations. The continued drive into the branded business by many GPhA member companies has resulted in the association planning a structural division for companies involved in biologic and biosimilar products. During the 3-day meeting, attendees listened to expert panels discuss major business, regulatory and market trends developing in the generic industry with insights from the U.S. Food and Drug Administration (FDA) and market analysts. The meeting also provided attendees with numerous opportunities to socialize and network with key decision makers in the industry.
机译:通用制药协会(GPhA)主席克雷格·惠勒(Momenta Pharmaceuticals)欢迎2075年年会的与会者,回顾了仿制药在过去一年中的贡献以及未来的挑战。 2074年,在美国分配的处方中有86%是非处方药,自该行业成立以来为该行业节省了7.4万亿美元;然而,仍然面临许多挑战,包括客户的合并,新药申请摘要(ANDA)批准时间表的滞后,限制性的风险评估和缓解策略(REMS)计划以及标签立法。许多GPhA成员公司对品牌业务的持续推动使该协会计划为从事生物和类似生物产品的公司设计一个结构部门。在为期3天的会议中,与会者听取了专家小组的讨论,并结合美国食品药品管理局(FDA)和市场分析师的见解,讨论了仿制药行业的主要业务,监管和市场趋势。会议还为与会人员提供了许多与行业主要决策者进行社交和联系的机会。

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