From concept to market
质量，监管，安全和商业合规性是确保药物和设备安全有效的基础，并以道德方式运营。但是，转移Global Regulatorycompliance environment means the impact of these requirements continues to expand, placing an increasing burden on drug and medical device manufacturers. A recent global survey of pharmaceutical CEOs1shows an increase in regulatory scrutiny across many aspects of the business, including sales and marketing practices, government drug price reporting, data privacy management, and clinical operations. Changes in industry regulations are now viewed as one of the top three disruptive business trends faced by pharmaceutical and life sciences organizations, and many pharma leaders view these changes as a threat to their growth.2
但是他们不必是。
长期以来，合规性一直被视为成本中心和必要性，但领先的组织正在认识到在这个领域的创新机会。
尽可能有效地满足监管合规要求，意味着建立一种积极的文化，以确保产品满足患者的需求，并且公司在道德上运作，转化为公司的增长，降低风险和更强大的品牌形象。相反，当公司将合规视为必不可少的，而不是增值且未能投资这些流程时，它们会增加可能涉及患者安全，延迟或拒绝产品批准，许可提款，经济罚款以及在IN中受损的风险最坏的情况是刑事处罚。这些不利的环境可能对个人生命科学公司造成破坏，并产生影响整个行业的负面看法。
为了避免这些风险并为合规过程增加价值，公司需要在其监管合规活动中寻找协同作用，这些活动用于建立技术和人才投资的商业案例，并确定机会以消除整个产品中的浪费和冗余生命周期。
Tearing down obstacles
当公司对法规对质量，监管，安全和商业合规要求的影响进行全面看法时，他们可以确定限制整体生产率并产生隐藏的废物和风险的共同挑战。这是推动监管和合规环境中创新的第一步。
These obstacles typically include:
- Lack of innovative technology and harmonization:While the pharma industry has invested billions in advanced technology, those investments have been slow to trickle down to compliance. Aging and disconnected platforms and lack of automation add time, cost, and poor visibility to the compliance process.
- Difficulty staying abreast of shifting global and local regulations:全球制药和医疗设备公司以及具有全球愿望的较小生物技术公司，需要对全球法规及其如何影响发展过程的专家。按国家和地区划分的监管变化，这可能是一个巨大的资源流失，但对于实现和维持遵守情况至关重要。
- Multiple silos/vendors/manual processes:Many companies lack horizontal integration of compliance tasks. Numerous vendors, disparate platforms, and lack of automation result in duplicative spending, lack of internal cost transparency, and inefficient operations.
- High volumes of unstructured data.整个数据集缺乏合规性使下游报告复杂化，并可能延迟维持合规性所需的实时见解。betway必威怎么提款
Once these obstacles are identified, business leaders can make the case for upgrades and investments. These may include implementation of centralized technology systems with advanced analytics capabilities to manage compliance tasks and capture data in a single data repository; hiring new talent or collaborating with industry partners to ensure all development decisions align with the latest global regulatory trends; and harmonizing delivery of external compliance tasks under a single industry partner who can provide deep domain expertise to increase transparency, avoid overlap, and leverage best practices to more efficiently meet all of the organization’s compliance needs.
实现未来
改变公司的合规方法需要时间和资源。有些人可能从试点项目开始，以更新一项技术或自动化报告的一个方面，而另一些则将投资于端到端的解决方案，从而从根本上改变了组织中合规性的文化。无论采用哪种方法，这些公司都应该进行研究，并与可以帮助他们确定近期项目的合作伙伴合作，这些项目将推动早期可衡量的节省，并为更大的转型工作奠定基础。
Although these transformations take time, they can significantly lower total costs while enhancing regulatory compliance and, in turn, reducing risks for patients, product development, and company reputation.
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1https://www.pwc.com/il/en/pharmaceuticals/managing-gregulatory-compliance.html
2https://www.pwc.com/gx/en/ceo-survey/industry/pdfs/pwc-ceo-survey-pharma-life-sciences.pdf
