Shift Work Maximizing Regulatory Publishing Efficiency

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In a testament to operational efficiency, numerous pharmaceutical companies are borrowing a page from a practice made famous by the manufacturing industry — namely shift work. While the advantage to the manufacturing industry is essentially using facilities and equipment round the clock to produce more goods, the pharmaceutical industry seeks to synchronize regulatory affairs and operation departments around the world. The added twist to this “new” shift work is maximizing the efficiency of highly educated employees with specialized skills located around the world.

Some Key Challenges
Needless to say, coordinating multiple locations in different time zones is challenging. Adding to the challenge are the relentless deadlines for submitting applications. Fortunately, the emergence of the ICH poster child – the electronic Common Technical Document (eCTD) – has provided the opportunity to train workforces in different regions in similar systems, workflows, and procedures to produce the harmonized application format. Now that your colleagues around the world are all pitching in, the challenge is maximizing operational efficiencies across the organization, and sometimes the ocean.

Invest in the Right Technologies to Communicate Effectively
After an organization makes the decision to implement a follow-the-sun business model, it is essential that the company invests in the technologies that ensure effective communication and the ability to coordinate efforts to create an environment of trust. Essentially, you and your colleagues become co-authors of the story of your application. To successfully tell your story to your audience (the agency), each operation must be on the same page with you as well as the agency.

Reduce Risk to Maximize Reward
While it is not practical to replicate your operations infrastructure to match that of the agencies, you can successfully plan to dramatically reduce your risks. As the size of your application grows or the financial rewards for a successful application increases, your risk also increases. To mitigate these risks, at a minimum you want to ensure your application will stand up to the validation criteria the agency applies and that all of your operations can view applications in the same manner as the agency. Other strategies would mitigate risks by following the process upstream such as ensuring each operation is using the same eCTD builder, document management system, SOPs, etc.

Stay Focused on your End-Goal
Instituting a follow-the-sun model, or 24 hour workday, by synchronizing your worldwide operations is a sound strategy to reduce cost and improve operational efficiency. To fully realize the benefits of this trend, focus on the communication and coordination of your operations, and never lose sight of your ultimate goal – presenting a clear story of the merits of your application.


Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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