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eCTD for Regulatory Affairs and beyond

  December 16, 2008  
eCTDconsultancy, Noordwijk - The Netherlands
16 & 17 June 2009

This course will offer insight into the regulatory environment of human pharmaceutical products, thereby focusing on the EU procedures and submissions and focusing on eCTD for global use. Emphasis will be on understanding the multidisciplinary tasks for the preparation and maintenance of regulatory documents.


KEY TOPICS 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


LEARNING OBJECTIVES 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


WHO SHOULD ATTEND? Regulatory Affairs Professionals from HQ and local affiliates Regulatory Operations Professionals CMC Technical Writers Nonclinical and Clinical Medical Writers Pharmacovigilance Managers QA and Compliance Professionals ICT Managers involved in document and submission management Contractors
Organized by: eCTDconsultancy
Invited Speakers: COURSE LEADERS Hans van Bruggen, MScSenior Regulatory Affairs Consultant Kevin Wing, BSc MScSenior Regulatory Operations Consultant Anne Mieke Reijnders, DVMRegulatory Affairs Consultant


Deadline for Abstracts: 2009-05-1
Registration:  Registration Fees*: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 € 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.  LiabilityeCTDconsultancy 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.bility for losses incurred by delegates in the event of postponement or other alterations to the meeting, i.e. timing, venue, etc.
E-mail: mstam@ectdconsultancy.com
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