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Seminar Alert!
Real life eSubmissions:
20th June 2008
Corus Hotel, Hyde Park, near Paddington, London.
Find out more here!
"I've just given my quick feedback to my colleagues about the course and raved about how good it was. Thank you, you de-mystified the eCTD for me" |
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| Hello and welcome to the first issue of the iRegulatory Newsletter. This newsletter will be sent once every two months to keep you informed of what's happening at iRegulatory and also to provide you with industry related articles, keep you up-to-date with events, answer your regulatory questions, give you access to competitions and more - absolutely free! You may also receive emails from us in-between, but we promise to use your email address sensibly - see our privacy and email policy here. |
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 Most regulatory professionals find that the ICH eCTD specification is not an easy document to follow, as it is written for professionals with specialist IT knowledge as well as regulatory knowledge. In addition, presentations and articles on eCTD have often focussed on IT rather than business aspects. In our view, the lack of clear and understandable information on eCTD has contributed to uncertainty, confusion and lack of enthusiasm for eCTD... read more.
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| A Brief Guide to Selecting a Translation Service Provider |
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Call for articles! Would you like to demonstrate your expertise in a particular subject? Know a lot about a hot topic that you'd like to share with our readers? If so, we'd love to hear from you! All suggestions welcome. Contact us now! Today, Samuel Wirth of Dora Wirth Languages gives us some tips on selecting a translation provider...
European Union (EU) enlargement since May 2004 has meant that the number of languages required for the Centralised Procedure (CP) has increased significantly, from English plus 12 to English plus 23 (including Icelandic & Norwegian). Translations are a critical factor in the regulatory process regardless of the procedure being followed. It is vital that your company selects the right source of translations. What factors should you consider and what is their priority in this selection process? Read more. |
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 This feature of the newsletter will endeavour to answer any regulatory or publishing questions you may have. As this is the first one, we're answering a question we're frequently asked by our clients. If you have any questions, please send them in - we'll answer you as quickly as we can and publish them in the next issue so that everyone else can benefit too.
Q. When should I decide on the granularity of our documents? Should I have a coarse or fine granularity?
Click here for the answer... |
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| Our top tip section of the newsletter will help give you the benefit of our team's experience and hopefully make your job a little easier. Today we're talking about text fonts and their compatibility issues. Click here to see our top tip! |
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 This section of the newsletter is here so you can take a 5 minute break from your hectic schedule.
Today we have the very first iRegulatory Crossword to test your knowledge of the regulatory and eSubmisison world!
Finally, we think our newsletter is currently lacking one thing - a name! Can you think of a good one? Send your entries in and if we choose it, we'll use it as the official name of the newsletter - and send you a prize! |
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Thank you for taking the time to read our inaugral newsletter, we hope you found it useful. If you have any suggestions, please don't hesitate to contact us.
iRegulatory
P.S. New for this edition is our Regulatory Calendar, with important dates such as EMEA submission deadlines. Take a look and see what you think! |
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