�ݺ�ߣshows by User: ectd-mstam

�ݺ�ߣshows by User: ectd-mstam / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: ectd-mstam / Mon, 12 Mar 2018 14:38:34 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: ectd-mstam Submitting electronic Drug Master Files (DMF) and Active Substance Master Files (ASMF) /slideshow/submitting-electronic-drug-master-files-dmf-and-active-substance-master-files-asmf/90397282 20160411dmf-180312143834
Presentation on Drug Master Files (DMF) and Active Substance Master Files (ASMF).]]>
Presentation on Drug Master Files (DMF) and Active Substance Master Files (ASMF).]]> Mon, 12 Mar 2018 14:38:34 GMT /slideshow/submitting-electronic-drug-master-files-dmf-and-active-substance-master-files-asmf/90397282 ectd-mstam@slideshare.net(ectd-mstam) Submitting electronic Drug Master Files (DMF) and Active Substance Master Files (ASMF) ectd-mstam Presentation on Drug Master Files (DMF) and Active Substance Master Files (ASMF). <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/20160411dmf-180312143834-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presentation on Drug Master Files (DMF) and Active Substance Master Files (ASMF).

Submitting electronic Drug Master Files (DMF) and Active Substance Master Files (ASMF) from eCTDconsultancy

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0 IDMP value beyond compliance /slideshow/idmp-value-beyond-compliance/63843695 idmpvaluebeyondcompliance-160708120851
About creating value beyond IDMP compliance by connecting information silo's.]]>
About creating value beyond IDMP compliance by connecting information silo's.]]> Fri, 08 Jul 2016 12:08:51 GMT /slideshow/idmp-value-beyond-compliance/63843695 ectd-mstam@slideshare.net(ectd-mstam) IDMP value beyond compliance ectd-mstam About creating value beyond IDMP compliance by connecting information silo's. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/idmpvaluebeyondcompliance-160708120851-thumbnail.jpg?width=120&height=120&fit=bounds" /> About creating value beyond IDMP compliance by connecting information silo's.

IDMP value beyond compliance from eCTDconsultancy

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0 IDMP and RIM: friend or foe? /slideshow/idmp-and-rim-friend-or-foe/50084196 idmpandrimfriendorfoe-150702082229-lva1-app6892
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]]> Thu, 02 Jul 2015 08:22:28 GMT /slideshow/idmp-and-rim-friend-or-foe/50084196 ectd-mstam@slideshare.net(ectd-mstam) IDMP and RIM: friend or foe? ectd-mstam <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/idmpandrimfriendorfoe-150702082229-lva1-app6892-thumbnail.jpg?width=120&height=120&fit=bounds" />

IDMP and RIM: friend or foe? from eCTDconsultancy

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0 Pros and cons of eCTD baseline submissions /slideshow/pros-and-cons-of-ectd-baseline-submissions/11137308 prosandconsofectdbaselinesubmissions-120118100207-phpapp01
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]]> Wed, 18 Jan 2012 10:02:05 GMT /slideshow/pros-and-cons-of-ectd-baseline-submissions/11137308 ectd-mstam@slideshare.net(ectd-mstam) Pros and cons of eCTD baseline submissions ectd-mstam <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/prosandconsofectdbaselinesubmissions-120118100207-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" />

Pros and cons of eCTD baseline submissions from eCTDconsultancy

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0 Pharmacovigilance evmpd submission /slideshow/pharmacovigilance-evmpd-submission-9727047/9727047 pharmacovigilanceevmpdsubmission-111017023706-phpapp01
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers ]]>
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers ]]> Mon, 17 Oct 2011 02:37:05 GMT /slideshow/pharmacovigilance-evmpd-submission-9727047/9727047 ectd-mstam@slideshare.net(ectd-mstam) Pharmacovigilance evmpd submission ectd-mstam The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pharmacovigilanceevmpdsubmission-111017023706-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers

Pharmacovigilance evmpd submission from eCTDconsultancy

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0 The Science of Submissions Part IA - The principles of the new variation regulation /slideshow/the-science-of-submissions-part-ia-the-principles-of-the-new-variation-regulation-7750918/7750918 thescienceofsubmissionspartia-theprinciplesofthenewvariationregulation-110427074703-phpapp01
About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities.]]>
About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities.]]> Wed, 27 Apr 2011 07:47:00 GMT /slideshow/the-science-of-submissions-part-ia-the-principles-of-the-new-variation-regulation-7750918/7750918 ectd-mstam@slideshare.net(ectd-mstam) The Science of Submissions Part IA - The principles of the new variation regulation ectd-mstam About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/thescienceofsubmissionspartia-theprinciplesofthenewvariationregulation-110427074703-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities.

The Science of Submissions Part IA - The principles of the new variation regulation from eCTDconsultancy

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0 The Science of Submissions Part IB - How to handle grouping and worksharing in eCTD /slideshow/the-science-of-submissions-part-ib-how-to-handle-grouping-and-worksharing-in-ectd/7750721 thescienceofsubmissionspartib-howtohandlegroupingandworksharinginectd-110427073841-phpapp02
Practical aspects of handling grouping and worksharing in eCTD, including NVR-related changes to the eCTD specification, impact on eCTD specific business processes, practical experience with planning and tracking , life cycle management complexities, cover letter authorisation and timelines.]]>
Practical aspects of handling grouping and worksharing in eCTD, including NVR-related changes to the eCTD specification, impact on eCTD specific business processes, practical experience with planning and tracking , life cycle management complexities, cover letter authorisation and timelines.]]> Wed, 27 Apr 2011 07:38:40 GMT /slideshow/the-science-of-submissions-part-ib-how-to-handle-grouping-and-worksharing-in-ectd/7750721 ectd-mstam@slideshare.net(ectd-mstam) The Science of Submissions Part IB - How to handle grouping and worksharing in eCTD ectd-mstam Practical aspects of handling grouping and worksharing in eCTD, including NVR-related changes to the eCTD specification, impact on eCTD specific business processes, practical experience with planning and tracking , life cycle management complexities, cover letter authorisation and timelines. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/thescienceofsubmissionspartib-howtohandlegroupingandworksharinginectd-110427073841-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Practical aspects of handling grouping and worksharing in eCTD, including NVR-related changes to the eCTD specification, impact on eCTD specific business processes, practical experience with planning and tracking , life cycle management complexities, cover letter authorisation and timelines.

The Science of Submissions Part IB - How to handle grouping and worksharing in eCTD from eCTDconsultancy

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0 https://cdn.slidesharecdn.com/profile-photo-ectd-mstam-48x48.jpg?cb=1544691501 eCTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/ strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient. www.ectdconsultancy.com https://cdn.slidesharecdn.com/ss_thumbnails/20160411dmf-180312143834-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/submitting-electronic-drug-master-files-dmf-and-active-substance-master-files-asmf/90397282 Submitting electronic ... https://cdn.slidesharecdn.com/ss_thumbnails/idmpvaluebeyondcompliance-160708120851-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/idmp-value-beyond-compliance/63843695 IDMP value beyond comp... https://cdn.slidesharecdn.com/ss_thumbnails/idmpandrimfriendorfoe-150702082229-lva1-app6892-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/idmp-and-rim-friend-or-foe/50084196 IDMP and RIM: friend o...