Do Electronic Submissions Save Pharmaceutical Companies Time? 62% says Yes!

With eCTD submissions taking a firm hold in the US and Japan, they are now making their mark in Europe. Now that eCTD submissions are becoming the preferred format for regulatory submissions in Europe it is essential for pharmaceutical companies to be equipped with in-house expertise and external solutions to ensure first time compliance and submission success. But what does the industry think of this “new” format?

In a recent survey, Pharma IQ asked members of the pharmaceutical industry if electronic submissions were in fact saving them time and making their life easier. The majority of respondents said yes (62.1%) but there was still a fair amount of people that thought it didn’t change the time spent on submissions and some stating it actually takes them longer.

The comments given reflect these mixed feelings;

One respondent working with Regulatory Affairs in the pharmaceutical industry made this comment; “The difficulty has not changed, it is just different. More focus on computer based skills and less manual labor. There is also an added challenge of smoothing out the processes surrounding submission requests and training staff on those processes as well as life cycle management.”

One person from Bayer Shering replied; “Life "after" paper isn’t easier, the challenge has just moved to another area.”
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Another comment highlights the need for processes and training; “Managing applications electronically has given us the potential to be more efficient, but unless we build processes that take advantage of technology, it can be like tangled fishing wire. It’s up to business to create, train, and support processes that can leverage the strengths that technology has to offer.”



With these comments in mind it is clear that preparation before implementation is key, so what better way than to learn from the experts? How to migrate to new submission processes and how to establish best practices for eCTD, as well as how to get the dossier right the first time are all topics covered at Pharma IQ’s 2^nd Successful Lifecycle Management conference taking place in Prague 14-15 September 2010. With confirmed speakers from Sweden Medical Agency, Latvian State Agency of Medicine, Swissmedic, EFPIA (to name but a few!), Successful eCTD Lifecycle Management will give delegates the opportunity to hear from the experts and get answers to those crucial questions.


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Editors Notes.Pharma IQ, a division of IQPC, is an international online community focusing on providing pharmaceutical professionals with knowledge, information and articles. We are dedicated to creating a learning environment for sharing ideas, best practices and solutions within the pharmaceutical community.

Through Pharma IQ, you will be able to access pharmaceutical information resources such as presentations and podcasts, as well as events such as webinars, seminars and conferences.

IQPC has an established reputation for delivering the highest standard of industry specific conferences, seminars and internal training programmes. We aim to keep business executives up-to date with the forefront of their industries’ trends, technological developments and regulatory landscape.

For any more information please contact: Viktoria Strandlund, +44 (0)20 7368 9300

viktoria.strandlund@iqpc.co.uk or visit www.ectdevent.com.