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FierceBiotech IT: Lisa Jenkins Interview
A FierceBiotech IT interview with ISI’s Lisa Jenkins who was recently appointed director for regulatory strategy.
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RAJ Pharma: Easing Electronic Migration in the EU
…Many of the larger companies have already made the transition from paper to electronic submissions…Firms of all sizes should, therefore, step up their efforts to automate their document publishing and life-cycle management activities (www.rajpharma.com) Read More
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FierceBiotech IT: Reg system targets data, user issues
ISI is attempting to kill two regulatory automation birds with one stone: ISIRegTracker version 4.2, part of its Regulatory Information Management system. Read More
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DIA Global Forum
...The purpose of this DIA article is to provide techniques for executing a successful FDA meeting and to highlight some strategies on what to do when something unexpected happens (© DIA 2010) Read More
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Pharmaceutical Technology: The eCTD Upgrade: Cross-Application Linking
…The worldwide shift toward the Common Technical Document (CTD) submission format promises a standardized global approach, while its electronic version, the eCTD, offers the functionality of digital-document management, manipulation, and storage. Both can streamline and speed the drug approval process. Read More
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Taking On The World: Harmonization Is Not Always Simplification
…While advances in the standardization of formats for regulatory submissions are providing global life sciences companies with new market opportunities, there is still a long way to go to reap the full benefits. Read More
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Biotech Shirks off the Market Blues
There can be no doubting that the recession has had a profound effect on the biotech industry, leaving many emerging companies at the mercy of a volatile and cash-tight market. Read More
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Taking On the World: One Size Does Not Fit All
Maximising international opportunities can create a substantial administrative headache, which is why standardisation offers such a positive way forward.
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Partnering Is More than Compounds in a Tech-Savvy Bio-World
Today's economic difficulties place the biotech industry in a precarious position. With venture capital scarce and development costs rising higher, biotechs are searching for new ways to sustain the business behind the science, and partnering with big pharma has become the preferred route for many. Read More
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Applied Clinical Trials: Managing Local Affiliates in a Multi-Submission World
…While advances in the standardization of formats for regulatory submissions are providing global life sciences companies with new opportunity, there are also associated challenges as they struggle to empower their local operating companies. Read More
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The Art of Getting Acquired
Early this year, a small West Coast biotech company began to think seriously about its infrastructure and data. Until then, the company had focused on the science of cancer, but as two of its oncology therapies entered phase III clinical trials, management needed a plan. Read More
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When Will RPS Get Here, And What Will It Bring?
Just as regulators and life sciences companies worldwide are coming to grips with electronic common technical document (eCTD) tools, formats, and requirements… the FDA are taking the submission process to yet another level by developing a new standard called Regulated Product Submissions (RPS). Read More
Life Science Leader Podcast
What biotech companies can do to increase their readiness for acquisition and/or consolidation.
Listen Now
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Applied Clinical Trials: The eCTD Advantage
Focusing on the IND as a product application starting point (and the typical beginning of the clinical trial period), this article will address eCTD structure and functionality and outline the possibilities and pitfalls of building a submission strategy that takes advantage of the cross-application linking feature to achieve the following...
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The outsourcing boom grows for non-core pharma activities
…Pharmaceutical organisations are being forced to re-examine where new efficiencies can be found, and to drive greater productivity and competitive agility into their operations. Read More
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Learning to Embrace the eCTD
Consider the enticing prospect of eliminating the blizzard of paper associated with regulatory submissions through a process in which applications are built once from the beginning, and then managed throughout their lifecycle. Read More
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ISI Streamlines Collaborative Space with SharePoint
ISI is bringing greater efficiency to the collaborative document management space with the integration of its Regulatory Solutions Suite with Microsoft Office SharePoint Server 2007. Read More
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Time to Grasp the Nettle on eCTD
There is nothing like international consistency to hearten businesses and improve the flow of trade between countries. The pharmaceutical industry should be delighted that Europe in finally standardising its position on electronic document submission, says Kate Wilber, director of regulatory services, ISI Europe. Read More
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Pharmaceutical Executive: Same Rod, Bigger Fish
A confluence of issues is causing sciences organizations to look into emerging markets as a way to maximize revenue streams, save on production costs, and conduct clinical trials…But targeting new markets presents a challenge. Requirements vary significantly from country to country, multiplying the administrative hurdles pharmaceutical companies have to clear to get their products to market. Read More
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Re-use of technology lies at the heart of business expansion
Life sciences organizations look to emerging markets which currently boast higher (double-digit) growth rates, such as China, India, Brazil, Russia, Mexico, Turkey and South Korea, to supplement their existing revenue streams. But targeting new markets presents a challenge.
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ISI is dedicated to keeping industry up-to-date on current regulations and interpreting agency guidances and providing practical roadmaps and best practice strategies on how to plan for and transition to electronic submission processes and systems. ISI's Sentinel Program is a regulatory thought leadership program that includes reports and webinars. Learn More
The European Medicines Agency has put electronic submissions front and center in its regulatory standardization drive. And while the emphasis is on the electronic Common Technical Document (eCTD), there is support from European Union (EU) regulatory leaders for a broader approach that encompasses the non-eCTD electronic submission, or NeeS.
With insights from an electronic-only champion at Sweden's Medical Products Agency and a leading expert on managing electronic product submissions, ISI's Webinar called eCTD and NeeS Take Center Stage explores the opportunities for creating a paperless environment, with the eCTD as the dominant format and the NeeS as the format of choice for older National Procedure submissions. Learn More
 Podcasts
ISI is proud to present a collection of podcasts that address industry challenges and trends. From regulatory standards to outsourcing trends, ISI podcasts keep you informed and updated.
Regulatory Expert Insight: Business Process Outsourcing
In the first of a series of special podcasts, industry expert Kate Wilber, director of regulatory services at ISI Europe, discusses the emerging trends in BPO and its benefits for pharmaceutical companies. Listen to the Podcast
Live from the DIA EuroMeeting
ISI’s Kate Wilber discusses the submission formats in Europe. Listen to the Podcast
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Collaborating with Local Operating Companies on
Multi-Regional Submissions
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As we move toward global regulatory harmonization in developing and launching new drugs, HQ operations are rethinking their relationship with Local Operating Companies (LOCs). To help sort through the models, an ISI regulatory expert and guest presenters from client company GlaxoSmithKline will bring forth the best practices for HQ-LOC multimarket submissions. Click here to download recorded webinar and white paper report.
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ISI in Partnership with Microsoft Webinar: The Path to
Effective Collaboration
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The need to improve the collaborative process has become more important for pharmaceutical companies, necessitating uptake of tools and processes that streamline networking internally and externally. ISI’s recorded Webinar on Microsoft’s collaborative technology Sharepoint provides you with insights into collaborative processes and ultimately to building “Innovation Networks.” Click here to download recorded webinar.
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Compliance-in-a-Box Submission Edition
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Click here to download a demo Webinar of Compliance-in-a-Box Submission Edition, an affordable and cost-effective solution to jumpstart enterprise deployments to comply with newly mandated eCTD formats. This solution, developed by ISI, EMC, and Impact Systems, combines EMC Documentum Compliance Management, preconfigured for regulatory submissions applications, integrated with ISI’s eCTDXPress, for submitting electronic content to worldwide regulatory agencies. This Webinar originally aired on April 3, 2008.
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Emerging Company
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"The Write Stuff - Preparing for a Compliant Submission", held on June 4th, 2008 is geared toward organizations that are new to electronic submissions and their requirements. This ISI Webinar and demo will address the challenges faced by emerging companies as they seek to lay the groundwork for organizational success and compliant submissions. Learn More
Click here to download a recording with accompanying PowerPoint of ISI’s latest Webinar, “Building Blocks, not Road Blocks for Success,” held March 13, 2008. Using real world insights, this webinar explored the different pathways emerging companies are taking in setting business strategy, addressed the drivers and priorities for growth, and clarified business process and technology solution options.
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| Information Management |
The “Managing Knowledge for Competitive Advantage” white paper communicates ISI’s predictions regarding the direction in which information management strategies are headed. It gives an overview of how XML standards and metadata will play a critical role in breaking down current information silos, allowing companies to efficiently get vital information to those who need it. It also presents a model to help organizations move from a document orientation to knowledge management in a flexible and stepwise fashion. Learn more
ISI’s Webinar, “The eCTD as a Springboard to Information Management,” will examine how life science companies are restructuring current practices and adopting new technology in order to harness the next generation of information management opportunities. Learn more
As the electronic common technical document (eCTD) is adopted as a universal standard for regulatory submissions, life science organizations are presented with the opportunity to achieve new levels of global efficiency and speed in regulatory submissions.This is the time to recognize the many advantages that the eCTD can deliver through a full global submission system that avoids time-consuming, duplicative effort and enables information-sharing and information-reuse. However, to fully leverage the power of the eCTD requires a well-planned strategy and diligent management that analyzes the entire process behind submissions. ISI’s white paper, “Global Vision: Using the eCTD to Gain its Fullest Benefits” will address the different approaches a life science organization can take when adopting an eCTD strategy. Learn more
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| ISI Product Innovation Series |
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It’s Go Time for Pharma CIOs: Five Trends Shaping 2008 View ISI’s latest webinar and download our thought leadership. As the gatekeepers of technology change, chief information officers (CIOs) are well-placed to reinvent the way life sciences companies collect, retain, and share the reams of data necessary for drug development. Drawing on the approach one top 20 pharma company took to transforming its processes and technology solutions and highlighting certain critical industry trends for CIOs to heed, this program offers valuable insights that could reshape the pharma business model, shorten regulatory cycles, and help progressive companies truly differentiate themselves. Learn more
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| Business Process Outsourcing |
Maximizing Your Outsourcing Investment
In recognition of these outsourcing trends, ISI has developed a white paper, "Maximizing Your Outsourcing Investment," that addresses the full spectrum of outsourcing, from determining your needs to managing your outsourcing partner. Read more
The Key to Keeping Up with Industry & Regulatory Evolution
With the globalization of economies and the proliferation of communications and data-linking networks, life science companies are better able than ever before to bring products to the worldwide marketplace. Of course, to be able to capitalize on this opportunity, managers need to juggle the varying requirements of dozens of regulating agencies, and update tools, training and education so that people and processes keep pace with advancing technology and regulation. This paper explores the business process outsourcing trend, and takes a look at how progressive companies are sharpening their competitive edge by forging vendor partnerships that improve speed, accuracy and economy by giving them instant access to first-rate people, processes and education. Learn more |
| eBooks |
An Introduction to RPS: Regulated Product Submissions
 Click here to download a copy of “An Introduction to RPS: Regulated Product Submission” eBook. It is designed to educate regulatory personnel on the Regulated Product Submissions (RPS) standard from HL7. It includes a brief history of electronic submissions, an explanation of why RPS was needed to extend beyond the existing eCTD standard, and a detailed explanation of the RPS Release 1 standard as approved by HL7 and ANSI.
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