A compelling model for small and medium-sized organizations in the current EU regulatory landscape
法规dynamics in the EU continue to evolve, with higher expectations for药物检修（PV）由于每个国家都有严谨性和复杂的患者安全法规。移位景观代表了在这一严格监管的市场中运营的小型企业的独特挑战。
我们经常谈论实现PV卓越via people, processes and technology but not in the European context. Our role is to ensure patient safety while optimizing a drug’s benefit-risk profile, and today we will consider an EU-specific PV model that builds excellence with人，质量和合规性.
人：发展组织卓越
小型公司有限或没有内部光伏功能，技术和资源。结果，通常外包给多个CRO，以及临床开发。因此，不存在中央，单个光伏数据库，因为数据跨多个CRO分段。达到末期第三阶段的公司需要通过在内部建立光伏专业知识或通过外包给客户等公司来巩固这一数据。
Additional resource challenges include the EU requirement for a responsible person (RP) during the clinical phase and a qualified person responsible for PV (QPPV) during market launch. Small- and medium-sized organizations need to ensure effective communication and awareness by allowing the RP/QPPV to influence processes across the organization with the support of a market authorization holder (MAH), which applies for registration in the country. Managing resources and costs of the complex process and requirements, along with having a dedicated QPPV, is a task in itself for the MAH. However, as the MAH expands, a dedicated QPPV office can support the process and manage deliverables.
越来越多的组织需要在整个患者之旅中增强光伏的专业知识和工具。示例包括欧洲法规和欧洲监管PV系统主文件（PSMFS）授权的安全评估，风险管理计划（RMP）。工作人员需要使用能够使用用于信号检测和跟踪的工具。
年代ponsors also face the complexity of establishing standard operating procedures (SOPs) and processes. Growing companies that attempt to build these capabilities in-house will inevitably look at outsourcing due to the realities of scale and finances.
Quality: building excellence into the QMS
The need to develop a robust quality management system (QMS) is driven by inspections as much as legislation; therefore, the focus is reactive rather than proactive. PV professionals become corrective and preventive action (CAPA) experts, as they respond to non-compliant procedures. For any noncompliance, they file a CAPA, but these often patch the problem rather than address the root cause, which may require additional time and expertise.
代理商有着看法，一些制造商产生了糟糕的质量报告，如所示ISMP,ncbi.,药物安全专家意见and inspection outcome data from the MHRA and the FDA. The quality of data processed and submitted to the agencies needs considerable improvement, and the value of the data being processed is questionable for the manufacturer. Small- and medium-sized organizations run a higher risk of noncompliance and its consequences, therefore turning to companies such as Covance to manage the quality process and systems that support it.
制造商了解来自某些来源及其患者安全价值的数据的局限性。但是，它们通常专注于满足监管义务，即使“更多数据”很少意味着“更高质量的数据”。安全组织不能孤立地建立有效的QMS;安全需要在公司层面的声音，影响组织的质量和活动。
遵守：在满足监管要求时促销卓越
Individual case study report (ICSR) compliance for patient adverse events (AEs) has been a key PV driver for WHO members. The standard has been 98% but hitting that target does not grant immunity from noncompliance, as specific PV aspects may not be under control. From an agency perspective, compliance is closer to 90%, according to aReuters Healthreport. We must, therefore, focus not just on quantity, but onqualityof data sources.
Increased scrutiny of PV and the QPPV role has created the need for resource-intensive monitoring. But what should companies monitor, and where should they allocate resources? Reconciliation among business partners is time-consuming, with little ROI. Small- and medium-sized organizations may not have adequate resources to build a PV department capable of handling risk management profiles (RMPs), signal detection and related functions. As companies expand, they need to ask whether a one-size-fits-all approach is appropriate, or if they should be taking a more pragmatic, risk-based approach. For example, they can develop simpler processes and focus fewer resources on managing mature products compared with those in the pre-approval period, while utilizing external expertise to fill operational gaps.
Advances and best practices in PV technology have often lagged requirements. Safety databases were built as transactional AE repositories and can barely keep up with reporting requirements. Signal detection tools have limited ability to integrate external data sources. Risk and benefit are often separately assessed by different resources and then cobbled together for a periodic report. Leveraging electronic health reports (EHRs) has yet to come to fruition from a risk-benefit perspective. As an industry, we need to effectively harness technology to gain efficiencies and manage resources more effectively.
In summary
如果我们记得PV的作用是确保患者安全的同时优化药物的利益风险概况，因此只能实现今天的运营卓越水平。由于中小型组织通过向欧盟市场引入产品来扩大其全球范围，以人物，质量和合规性建立PV卓越，至关重要。一种提供者，如Covanceoffers flexible staffing, quality systems and regulatory expertise to help these organizations succeed in the highly regulated EU landscape.
