制药行业中的监管事务角色正在迅速变化，许多任务曾与内部专家一致。这种趋势迫使行业专业人员重新考虑自己的角色，并确立自己的思想领袖，他们为公司的业务带来了可衡量的战略价值。本洞察摘要研究了监管事务工作向当地枢纽的转移，这为监管专业人员直接与监管机构合作，为其各自组织提供了思想领导力的投入，并随着专业的不断发展而支持产品开发。自2015年以来，基于在150多个国家 /地区提供超过150个国家 /地区的7,000多个产品登记的市场领导地位，此洞察摘要与合作伙伴Bristol-Myers Squibb从IQVIA的全球监管事务见解有关，对监管事务专业和行业的未来。王者荣耀kpl外围投注

简介：悠久的视野

Over the past several decades, the trajectory of the Regulatory Affairs function has evolved to its current position at the hub of the development wheel and a dynamic engine of R&D (Figure 1). In terms of outsourcing Regulatory Affairs tasks, we can look back a decade or so to Data Management and Biostatistics functions, which were primarily country- or region-based with similar work conducted in many different geographies. In contrast, today, many staff within these functions are located offshore and are coordinated by global project managers, often based in developed countries. In addition, we are seeing a rapid acceleration of compounds originating outside of the companies ultimately responsible for marketing them. A decade ago, one-third of approved drugs sold by big pharma companies were sourced from outside their organizations. Today, this has risen to between 51% and 70%.

过去和现在

Ten years ago, a regulatory affairs specialist could expect to start out in a role at a company’s headquarters or regional affiliate, working on all aspects of regulatory affairs, covering country- or region-specific projects only.

如今，随着外包部门的成熟以及技术和流程的发展，监管事务专业正在发生变化。必威官方在线现在，监管事务专业人员通常专注于单个子过程，通常从事孤岛工作，并有不完全了解整个产品开发范围的风险。

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