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        <title>Qdossier.com news</title>
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        <description>RSS feed of Qdossier.com headlines</description>
        <lastBuildDate>Sun, 05 Feb 2012 18:44:06 +0100</lastBuildDate>
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            <title><![CDATA[02/02/2012 Start collecting your XEVMPD data today to meet the aggressive timelines..]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=23</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=23</guid>
            <description><![CDATA[
To populate and update the EVMPD, all Marketing Authorisation Holders have to submit their EVMPD data before July 2012. The submission format must be in compliance with a technical electronic protocol (XML Schema Definition). All the data must be gathered from various sources and the terminology used must be aligned across products and countries. 
Although the final data requirements for the are not yet available; to meet the aggressive timelines Companies should no longer wait to collect their submission data and documents. By using Qdossier’s QEVMPD Collection Form&nbsp;MAH’s and sponsors can easily start collecting data from various sources in a structured way, without having to wait before all business processes and IT infrastructure is ready. The data form is used to collect the information from the various disciplines, automatically calculates the expected output values for the XEVPRM message and uses pick lists to populate the data fields in an efficient and consistent way. The business rules from the EVMPD guideline have been incorporated and automatic checks are included for the data string length to ensure all entries are technically valid.
Contact&nbsp;us for more information and a live demo of&nbsp;the QEVMPD&nbsp;Collection Form. ]]></description>
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            <title><![CDATA[20/10/2011 (e)Submission content plan and document templates]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=22</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=22</guid>
            <description><![CDATA[Qdossier introduces a full set of (e)Submission document templates&nbsp;that have been designed for optimal support of all authoring and submission practices within your organisation.&nbsp;The document templates can be used toghether with the&nbsp;(e)Submission content plan, which&nbsp;provides an integrated overview of the submission outline.&nbsp;The systematic approach and harmonized definition of document names and the submission outline results in optimal reusability of documentation across products, regions and formats.]]></description>
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            <title><![CDATA[11/05/2011 Update of BfArM eValidator]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=21</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=21</guid>
            <description><![CDATA[
A new version of the 'eValidator' used by German BfArM has been released. The new Service Pack integrates the validation criteria updated on the European level into the eValidator. This update includes a service pack that integrates the current draft EU validation criteria for eCTD (version 3.1) and NeeS (version 2.1) that will come into force on September 2011.Submissions, received by BfArM after this date and presenting errors in the validation report will be rejected. The name of the profile will be 'EU' from now on as no specific BfArM requirements have been established. During implementation and testing the necessity for corrections may arise; these will most likely be implemented after 1 September 2011. Applicants are strongly advised to re-download the ZIP-file. For the download and installation: click hereFor more information on the BfArM website: click here]]></description>
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            <title><![CDATA[18/04/2011 RAPS 'Advanced eCTD submissions' - Longbeach CA, 20 - 22 July 2011]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=20</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=20</guid>
            <description><![CDATA[
Hans van Bruggen&nbsp;will present on 'eSubmissions in the EU' during&nbsp;the RAPs 'Advanced eCTD Submissions' interactive workshop, 20-22 July 2011, Longbeach California, USA.
Advanced eCTD Submissions
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 1 January 2008 and as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV) is implementing a single electronic review environment for all FDA Centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMEA) has required eCTD format for Centralized Procedure applications since the beginning of last year (1 January 2010). Some regulatory authorities in Europe have implemented all electronic review environments ahead of this deadline and are refusing to accept paper submissions for review. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance with the electronic format and difficulty navigating the electronic files that comprise an eCTD, which are preventing them from conducting their review.
Designed to build upon the foundation provided in RAPS™ Preparing Compliant eCTD Submissions Workshop, this interactive, hands-on advanced training seminar will provide the experience of compiling an eCTD submission in the research and development phase, repurposing the content for submission to multiple regulatory authorities, and the challenges and benefits of using document granularity over a drug submission's lifecycle. Region-specific experts will teach participants about the detailed contents of all modules of the eCTD, the differences in Module 1 for the US, Canada, Europe, and Japan, and how regional differences impact Modules 2 through 5. Attendees will also learn how eCTD submissions in the research and development phase differ from those for marketing applications.
By participating in this workshop, you will not only know how to strategically prepare submissions in the US, Europe, Canada, and Japan, but you will assess and improve submission processes, workflow, and teamwork to achieve less stress and cost to your organization.

Learning Objectives
Upon the conclusion of this program, participants should be able to:


Describe the differences in regional requirements for FDA, Health Canada, EMEA, and MHLW 
Use granularity in document content to prepare INDs in eCTD format 
Use granularity and lifecycle to prepare marketing applications in eCTD format 
Develop a table of contents for an eCTD submission with a goal of simultaneous global submissions 
Understand the direction global regulatory authorities are taking to standardize on the eCTD format and the strategic implications for their companies 

NEW Program Additions!


Hands-on eCTD publishing experience 
Compile an eCTD application with multiple submission sequences in compliance with US FDA guidances and specifications 
Clone the submission sequence 0000 for modification to comply with EMEA eCTD specifications for Centralised Procedure 
Validate and view the applications against relevant ICH and agency guidances and specifications 

Audience Level
This advanced eCTD workshop is beneficial for professionals working in drugs or biologics and who have had experience preparing electronic submissions using formats prior to the eCTD standard, particularly medical writers, regulatory operations, submissions publishing and IT staff. It is intended for individuals who have attended one of RAPS'™ Preparing Compliant eCTD Submissions Workshops or have prior experience with earlier generations of submission publishing.
Professional Levels: Intermediate
Product Coverage: drugs & biologics & veterinary
Geographic Coverage: Europe, US, Canada, Japan(source and more information about this workshop: www.raps.org) ]]></description>
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            <title><![CDATA[01/12/2010 EMA widens public access to documents]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=19</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=19</guid>
            <description><![CDATA[
The European Medicines Agency (EMA) has published its new policy on access to documents related to medicines for human and veterinary use. The new policy is part EMA's response to increasing public demand for more openness and transparency. It will give wider access than ever before to documents held by&nbsp;EMA, while it ensures that personal data and commercial confidential information remain adequately protected. Click here for more information.]]></description>
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            <title><![CDATA[29/11/2010 EMA released draft guideline on biosimilar medicines]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=18</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=18</guid>
            <description><![CDATA[
EMA&nbsp;has released the draft guideline on similar biological medicinal products containing monoclonal antibodies for a six-month consultation period.
The guideline lays down the requirements for medicines containing monoclonal antibodies that claim to be similar to another such medicine already marketed.
Comments on the draft guideline can be submitted to EMA up to 31/05/2011.
EMA&nbsp;has also released a related guideline on the immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use for consultation until the same date.
For more information, see:


the draft guideline on similar biological medicinal products containing monoclonal antibodies 
the draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use]]></description>
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            <title><![CDATA[  01/12/10 - 03/12/10 - DIA Conference on European Electronic Document Management  ]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=15</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=15</guid>
            <description><![CDATA[
In an evolutionary environment, it seems that every time one overcomes a hurdle one discovers a whole new world to conquer. Similarly, in EDM we now discover the new frontiers: Electronic gateways and advanced submission standards such as CDISC and RPS that extend the capabilities and flexibility of information exchange, new approaches for Enterprise Information Management, simpler and more affordable tools allowing compliant EDM for small corporations, collaborative and component-based authoring and new, powerful user interfaces are only some of the emerging novelties. Information sharing in the public domain has reached previously unthinkable levels and new techniques of information management are needed to handle both the disclosure and analysis of this new information eldorado.On the regulatory submissions front, CTD and eCTD are now well known and understood and thousands of submissions are now managed as eCTDs. Within stable EDM technologies, is this it? Have we solved all eCTD questions? What now for EDMS?Join the 11th DIA Conference on European Electronic Document Management to hear from the pioneers of this new conquest and become part on the adventure at the new frontiers.]]></description>
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            <title><![CDATA[08/11/2010 PIM Guidance for Applicants V3.1]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=16</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=16</guid>
            <description><![CDATA[
PIM Guidance for Applicants V3.1 is available for download here. For details of what has changed since the last version, see the 'What's New' section within the document.]]></description>
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            <title><![CDATA[05/11/2010 CMD(h) updates requirements on eSubmissions for New Applications within MRP, DCP or National Procedures]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=17</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=17</guid>
            <description><![CDATA[
An updated document with national requirements on electronic submissions for New Applications within MRP, DCP or National procedures has been released by the CMD(h). Click here to download&nbsp;the&nbsp;full document form the CMD(h) website. &nbsp;]]></description>
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            <title><![CDATA[05/02/2010 - ASMF final draft guidance document]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=14</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=14</guid>
            <description><![CDATA[A joint working group comprising representatives from EU Regulatory Authorities, The European Medicines Agency, industry, EDQM and ASMF holders has drafted a guidance document covering practical and technical points related to the submission and handling of the ASMF in eCTD. As this is a final draft, the guidance should be implemented, but as experience with eCTD and ASMF is gained, comments are actively sought, with a view to updating the guidance as necessary in July 2010. (source:http://esubmission.ema.europa.eu/doc/index.html)]]></description>
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            <title><![CDATA[04/02/2010 - New Belgian checker v2.8 released]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=13</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=13</guid>
            <description><![CDATA[FAGG&nbsp;has released a new version of the Belgian eSubmission checker. Since 01/02/07 each electronic file submitted to FAMHP (Federal Agency for Medicines and Heath Products) for medicines for human use undergoes two technical checks: 
-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Compliance towards &nbsp;the CTD tree structure-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Compliance towards folder and file naming
The score that a file must achieve for all technical checks in order to be accepted by &nbsp;FAMHP is determined by a road map. This road map should always be consulted before submitting a file so that you have the latest information about the minimum scores.&nbsp;&nbsp;(source)]]></description>
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            <title><![CDATA[21/09/2009 - New Electronic Application Forms NTA Vol 2b]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=12</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=12</guid>
            <description><![CDATA[The Notice to Applicants Volume 2b&nbsp;on the Eudralex website has been&nbsp;updated. EMEA has developed&nbsp;the new versions of the Electronic Application Forms (eAF-New,eAF-Variation,eAF-Renewal) that should replace&nbsp;the&nbsp;old XML files (2007) ]]></description>
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            <title><![CDATA[16/07/09 - Swiss eCTD Module 1 specifications and validation criteria]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=11</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=11</guid>
            <description><![CDATA[Swiss Medic has published&nbsp;drafts of the 'Swiss eCTD Validation Criteria' (describes the criteria for technical validation of eCTD submissions in Swissmedic) and&nbsp; 'Swiss Module 1 Specifications for eCTD'&nbsp; (describes the requirements a valid Swiss Module 1 in eCTD format has to comply with) on their website. The specifications represent&nbsp;drafts that may undergo some changes until they are&nbsp;published as versions 1.0 in October 2009. (source) ]]></description>
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            <title><![CDATA[01/07/09 -  EMEA updated dossier requirements for post-authorisation submissions]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=10</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=10</guid>
            <description><![CDATA[The EMEA has updated the&nbsp;new Dossier requirements for Post-authorisation submissions in the Centralised Procedure. EMEA/300339/2008 (source) ]]></description>
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            <title><![CDATA[15/05/09 - CMD(h) requirements on electronic submissions]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=9</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=9</guid>
            <description><![CDATA[The CMD(h) have published their requirements on electronic submissions for New Applications, Variations and Renewals&nbsp;within MRP, DCP or National procedures.]]></description>
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            <title><![CDATA[15/05/09 - Revised v2.1 EU eCTD validation criteria ]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=8</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=8</guid>
            <description><![CDATA[
A revised v2.1 of the EU eCTD validation criteria has been published&nbsp;by EMEA, to explicitly support EU M1 v1.3 and to include a new criterion no.11 on the calculation of the checksum. (source)&nbsp;]]></description>
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            <title><![CDATA[30/03/09 - Swiss Medic to accept eCTD in 2010]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=7</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=7</guid>
            <description><![CDATA[Swiss Medic has announced on their website to accept eCTD in 2010. Recenlty a document has been published containing the milestones for the so called SIMES projekt. (source) ]]></description>
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            <title><![CDATA[26/03/09 - CMD(h) eCTD Implementation Report available]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=6</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=6</guid>
            <description><![CDATA[
The CMD(h) has published the eCTD Implementation Report covering the period from July 2007 to June 2008. The goal of the survey report is to summarise the current status of readiness of the European Medicines Regulatory Network and eCTD implementation to monitor progress towards the target of 2009.(source)]]></description>
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            <title><![CDATA[27/01/09 - EMEA dossier requirements for Post-authorisation submissions]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=5</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=5</guid>
            <description><![CDATA[
The EMEA has adopted the new Dossier requirements for Post-authorisation submissions in the Centralised Procedure. EMEA/300339/2008 (source) ]]></description>
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            <title><![CDATA[20/01/09 - TGA eCTD draft guidance v1.5 ]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=4</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=4</guid>
            <description><![CDATA[The TGA has initiated a project that will culminate with the data dossiers for all prescription medicine applications being received in electronic CTD (eCTD) format. The&nbsp;TGA has published a Draft Guidance for Industry on Providing Regulatory Submissions for Prescription Medicines in Electronic Format (eCTD) in Australia.Also part of the TGA project is to&nbsp;develop a specification for the Australian Module 1 (Region Specific information) of the eCTD. 
It is expected that the media for receiving eCTDs initially will be CDs or DVDs and that there will be a transition period where both eCTD and hardcopy CTDs will be accepted prior to eCTDs becoming mandatory. (source)]]></description>
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            <title><![CDATA[13/01/09 - EMEA eCTD implementation strategy]]></title>
            <link>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=2</link>
            <guid>http://www.qdossier.com/content/qdossier_news.asp?nieuwsId=2</guid>
            <description><![CDATA[EMEA has announced plans to mandate the use of the Electronic Common Technical Document (eCTD) format for electronic-only submissions in the centralised procedure from 1 January 2010.&nbsp;From July 2009 until 1st January 2010, EMEA will continue to accept non-eCTD electronic-only submissions (eCTD is, however, the recommended format). In addition EMEA has announced that&nbsp;any non-eCTD electronic submission provided in the context of the Centralised Procedure must also comply with the EMEA’s new specific guidelines for non-eCTD electronic submissions. The introduction of mandatory eCTD is an extension to the existing EMEA strategy for implementation of electronic-only submissions and eCTD. ]]></description>
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