On November 19th, the European arm of international submissions management specialist, ISI, will co-host a timely Introduction to eCTD workshop with The Organisation for Professionals in Regulatory Affairs (TOPRA). The aim is to prepare regulatory professionals for the strict new EMEA guidelines that will come into force on January 1st, 2010, concerning the way drug licence application submissions must be made.
These specify that, from the turn of the decade, Centralised Procedure submissions must now be made in electronic format only, preferably using the formal ‘electronic Common Technical Document’ (eCTD) standard.
The one-day workshop will feature discussions on all pertinent topics relating to electronic submissions, and the eCTD standard in particular. The event is accompanied by an eCTD Workshop Guide, which, afterwards, will double as a handy reference manual.
Participants will be brought up to date on the history and benefits of the eCTD; the global regulatory context; high-level technical aspects, structure and granularity of documents; and basics of file placement and document lifecycle, compilation and review.
The workshop will be led by field-experienced trainers with expert knowledge of eCTD and regulatory submissions.
Who should attend?
The event is designed for all industry professionals with little to no experience of eCTD, who are currently, or are planning to be, involved with the development of eCTD submissions. This includes professionals in: medical writing, regulatory affairs, dossier and document management, IT and data management, compliance, publishing and submission management.
“ISI is firmly committed to NeeS for as long as the standard is in use,” notes ISI’s European MD Adam Sherlock. “While some of our competitors appear to be withdrawing their support for the format with the original expectation that such submissions would cease by January 2010, ISI will continue to support it for as long as the standard applies. We recognise that it still has considerable longevity.”
By attending, delegates will:
• Learn about the process that led to the development of the eCTD;
• Understand the global regulatory context surrounding eCTD;
• Gain a thorough understanding of eCTD concept and structure;
• Become familiar with the underlying XML technology used in the eCTD;
• Understand how the eCTD organises study files, including Node Extensions, Study Tagging Files, and the regional requirements for datasets and case report forms;
• Learn about lifecycle management advantages of the eCTD;
• Glimpse the challenges and logistics of submission logistics;
• Ask questions to an eCTD specialist;
• Exchange ideas with other participants;
• Receive detailed reference tables on the granular content of each section of a submission.
Jennie May, Regulatory Consultant, ISI Europe
Jennie is a specialist Regulatory Consultant at ISI Europe, where she helps life science companies of all sizes manage the transition to eCTD within the complex submissions environment of the EU marketplace.
Katja Wagner, Senior Regulatory Operations Manager, ISI Europe
Katja is Associate Director of Regulatory Operations at ISI Europe, where she helps life science companies build paper, NeeS and eCTD submissions that satisfy regulatory requirements in the world’s major marketplaces.
Where and when
The Introduction to eCTD workshop will take place on Thursday November 19th at:
Radisson SAS Portman Hotel
22 Portman Square
London, W1H 7BG
T: +44 (0)20 7208 6000
All day event, session starts at 9:00 am GMT
Cost to delegates
TOPRA members: £569.25 (including GB VAT at 15%)
Non-members: £684.25 (including GB VAT at 15%)
LIMITED SPACES AVAILABLE
To reserve places
Book online now at topra.org/eCTDintrobf or contact TOPRA at:
T: +44 (0) 20 7510 2560
F: +44 (0) 20 7537 2003
TOPRA (topra.org) is a global non-profit, non-political organisation for regulatory affairs professionals and those with an interest in regulatory affairs in the healthcare sector. Its members, which today span over 40 countries, are actively involved in delivering the services needed by busy regulatory specialists. TOPRA’s remit is to advance the status of the regulatory profession through education, and provision of information to its members. Its training programmes are highly regarded and internationally recognised across the regulatory affairs profession.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.