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News

Regulatory workshops to be held in Spain

Image Solutions : 04 May, 2009  (New Product)
Pharmaceutical companies in Spain can benefit from workshops being run by ISI to introduce new regulatory requirements for electronic publishing in the industry
Image Solutions (ISI) has unveiled a timely programme of workshops to ease the transition to electronic publishing formats for regulatory submissions in Spain. These will be held in early May in Madrid and Barcelona.

As of January 1, 2009, Spain's authorities have mandated that regulatory submissions must now be made in electronic format, preferably the eCTD (electronic Common Technical Document) standard.

Recognising the time-consuming complexity associated with managing this transition, ISI Europe has announced a series of workshops designed especially for pharma companies publishing submissions in the Spanish market.

The workshops, to be held in Madrid on Thursday May 7 and Barcelona on Friday May 8th, will cater for both the eCTD standard, and Non-eCTD Electronic Submissions (NeeS), as Spain currently supports both options.

The instructor-led, half-day sessions, to be followed by optional hands-on sessions, are free to Life Sciences companies and independent regulatory consultants, and will cover the following:

• An eCTD overview, introducing the fundamental concepts of eCTD as well as ISI's eCTDXPress system for creating compliant eCTD submissions
• Practical and Technical Aspects of eCTD Implementation
• PDF document readiness and NeeS creation, based on ISIToolbox
• Active discussions covering business challenges, process and technology.

The formal morning session will cover key eCTD topics of interest to the European market, and is designed for industry professionals with little to no experience with eCTD, who may be involved with the development of an eCTD submission or the selection of an eCTD technology solution. This includes professionals who may be responsible for regulatory affairs, dossier and document management, IT and data management, compliance, publishing and submission management. Attendees will receive a reference manual for future use.

The sessions will be led by field-experienced consultants who have industry expertise in eCTD systems selection, implementation and, ultimately, eCTD compilation. With experience compiling over 1,000 eCTD submissions through their global outsourcing teams, ISI is uniquely able to share field-tested experience and best practices with workshop participants.

An optional post-conference hands-on workshop, meanwhile, will take an in-depth look at the practicalities of NeeS compliance. From 1 January 2009, Spanish authority, AEMPS, has mandated electronic submission of Regulatory Dossiers, at a minimum in the Non-eCTD electronic Submission (NeeS) format.

This practical session will explore specifically how Image Solutions' ISIToolbox solution can help bring pharma organisations in line with these requirements. The workshop will cover building a NeeS submission from scratch, as well as modifying a NeeS submission for local content (as in the case of MRP or DCP).

This workshop is intended for those individuals who are responsible for building compliant NeeS submissions for their registration dossiers. Space is limited to 15 participants.

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