In its continuing mission to alleviate the burden of international regulatory information management for global pharma organisations, ISI has stepped up its programme to create a culture of information management ‘discipline’ in the industry.
The current year is proving a particularly busy time for regulatory information management initiatives as industry copes with new compliance mandates, explores various cost-cutting models and strategies to maximise commercial opportunities for existing products and supports a robust pipeline of new therapies. In addition, as mergers and acquisitions continue at a brisk pace, companies are faced with the additional complexities of integrating acquired companies’ products and tracking those therapies through their lifecycle.
For global pharma organisations, keeping track of which products are registered where, and what the latest requirements are in any given market (for example, with regards to eCTD submissions), is a full-time job and one that is hard to get right without a systematic approach to information management.
With this in mind, and hot on the heels of a busy webinar programme which continues into the autumn, ISI has announced a jointly hosted event with independent software industry analyst, Ovum, to be held in London on September 24th.
The event is part of the company’s ‘Stay in the Know’ campaign, which launched this year and includes a whole host of information-driven initiatives to improve pharma companies’ regulatory management activities. In addition to the Ovum forum, ISI has been running periodic webinars to keep customers fully informed, and will soon announce a new dedicated web site, drawing together a whole host of content and useful resources to make it easier for pharma companies to get up to speed with the global regulatory scene and ways they can shore up their own internal tracking capabilities. Additionally, the company has just published a new report, Mind the Gaps; imagesolutions.com/MindTheGaps
The informal, interactive session, Regulatory IM – Face to Face with ISI & Ovum: An Executive Exchange, will feature presentations from Sarah Burnett, a senior analyst and regulatory information management specialist at Ovum, and Ken VanLuvanee, VP of Global Professional Services at ISI and an experienced regulatory IM consultant. ISI is a market leader in regulatory submissions software solutions, outsourcing and advisory services, and provides a holistic, consultancy-driven solution for global regulatory information management as companies deal with the broader issues around their global regulatory processes and the data that they’re tracking.
The Regulatory IM – Face to Face session will promote the idea of having a central framework for regulatory information management, built on best practices, to ensure successful initiatives.
It will examine specific challenges and drivers facing pharma organisations as they navigate the complex and continually changing regulatory landscape across the various EU member countries, as well as Far Eastern territories and emerging markets.
The session will be particularly suited to organisations with a need to:
• Gain a greater insight into, and decision-making capability around, their product portfolio;
• More operational management on submissions and the resources that manage them;
• The status of registrations around the world.
A comprehensive Regulatory IM strategy should incorporate submission management, registration management, portfolio management and resource planning. “To really get a grip on where they are, so that they can tighten processes, a company needs to get a handle on the entire information lifecycle - and the various components from across the business that feed into it – so that it can make smarter decisions about its portfolio,” explains ISI’s European MD, Adam Sherlock.
ISI identified this need early on, and, recognising that no two companies’ needs are the same, offers a collaborative, services-led approach and best practice-based methodology to regulatory information management, which extends beyond simply deploying special software.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.