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eCTD for Regulatory Affairs and beyond...
'Introduction to the Regulatory Environment, Dossier Content and Electronic Submissions'
EU regulatory environment for human pharmaceutical products and its place within worldwide regulatory affairs. Product lifecycle Regulatory procedures in the EU Types of application in the EU Types of submissions in the EU and beyond Formats of regulatory dossiers (eCTD, NEES, paper) eCTD lifecycle management Workshops on preparing and maintaining regulatory dossiers
At the conclusion of this course the attendants should be able to: Understand the regulatory environment for pharmaceutical products Know where to locate regulatory information in a regulatory dossier See how the eCTD lifecycle reflects the product lifecycle Understand the importance of reusability of documents to support multiple countries and products See where regulatory information is reused within a pharmaceutical company Contribute to the first-time-right eCTD-readiness of documents Contribute to implementation processes for eCTD-readiness of a company Participate in integration of document management and registration tracking across a pharmaceutical company
Regulatory Affairs Professionals from HQ and local affiliates Regulatory Operations Professionals Project/program leads of company eCTD implementation projects CMC Technical Writers Nonclinical and Clinical Medical Writers Pharmacovigilance Managers QA and Compliance Professionals Contractors IT Managers involved in document and submission management Employees of software vendors within the field of eCTDs and document management Regulatory Authority Representatives
Koningin Astridboulevard 23 2202 BJ Noordwijk The Netherlands Phone:+31 713 690 100
Euro 1495*: Including course, 1 night Hotel (June 16), meals, drinks. Euro 1665*: Including course, 2 nights Hotel (June 15 and 16) meals, drinks. After registration you will receive an invoice with all bank details for payments by bank transfer. Your place is secured only upon receipt of full payment. (* excluding 19% VAT) Cancellation: All cancellations must be received in writing before 16 May 2009 and will be subject to an administration fee of EUR 200,-. For cancellations after this time, or if the delegate fails to attend the course, no refunds of fees will be given. If you cannot attend, you may send a substitute person. The original registrant must submit a written authorization. Liability eCTDconsultancy reserves the right to cancel the course at any time without liability. In these circumstances delegates will be offered an alternative date, a credit note or a full refund. eCTDconsultancy cannot accept liability for losses incurred by delegates in the event of postponement or other alterations to the meeting, i.e. timing, venue, etc. Registration & more information: eCTDconsultancy B.V. Jan de Rooystraat 8 5141 EN, WAALWIJK The Netherlands registration@ectdconsultancy.com 
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Submission Preparation and Management
Regulatory Affairs