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Preparing Compliant eCTD Submissions Workshop

  July 12, 2010  
Regulatory Affairs Professionals Society (RAPS), Brussels
15-17 November 2010

Monday, 15 November 2010
9:00-9:15Introduction and Day I Overview
9:15-10:00What is an eCTD for the US?
10:00-10:15Refreshment Break
10:15-11:45What is an eCTD for Europe and How Does It Differ From US?  How is It the Same?
Looking at eCTD for European Medicines Agency and Other European Bodies
11:45-12:45Luncheon Provided
12:45-14:45Issues Regarding the Content of an Electronic Submission
14:45-15:00Refreshment Break
15:00-16:45How to Produce Your eCTD
  • Conduct eCTD Readiness Assessment
  • Review of eCTD Vendors & Implementation Options
  • Role of Electronic Document Management in eCTD Authoring
  • How to Integrate the eCTD Culture Within Your Company
16:45-17:00Questions & Answers
Review of Day I

Tuesday, 16 November 2010
9:00-9:15Day II Overview
9:15-10:00Best Practices in Use of MS Word and Adobe Acrobat Professional (demonstration)
10:00-10:15Refreshment Break
10:15-12:00Building the eCTD (demonstration)
  • Initial Submission
  • Lifecycle Management
  • Repurposing eCTD for Another Country
12:00-13:00Luncheon Provided
13:00-14:00Feature Topics and Hot Tips From Industry
14:00-15:00Labeling Challenges in Europe
15:00-15:15Refreshment Break

Interactive Breakout Session
Conduct an eCTD Readiness Assessment for a Hypothetical Company and Build Your Findings and Recommendations

16:15-16:45Present Findings and Recommendations of Breakout Session
16:55-17:00Questions & Answers
Review of Day II
Wednesday, 17 November 2010
8:30-10:00Put It to Practice:  Hands-on Activity, Part I
MS Word and Adobe Acrobat Professional
10:00-10:15Refreshment Break
10:15-12:00Put It to Practice: Hands-on Activity, Part II
Tools for QC’ing the eCTD and Validation
Organized by: Regulatory Affairs Professionals Society (RAPS)
Invited Speakers: Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organisation in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting life sciences practice. Azevedo's experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.

Hans van Bruggen Msc, director of Qdossier, has many years of practical regulatory experience in the pharmaceutical industry. Van Bruggen led the successful submission and validation of the first eCTD for an initial Marketing Authorisation Application worldwide for a new chemical entity. He has a wealth of experience, specializing in first time right eCTD lifecycle management and has built up a solid reputation within the pharmaceutical industry and agencies.
Deadline for Abstracts: N/A
Product Detail

Preparing Compliant eCTD Submissions

- Available
Valid from: November 15, 2010 - November 17, 2010

REGISTRATION FEESRegister by 25 October 2010Register after 25 October 2010
RAPS Member$1495 (approx. €1,095)$1595 (approx. €1,165)
Nonmember*$1685 (approx. €1,235)$1785 (approx. €1,165)
Multiple Members**$1295 each (approx. €945)$1395 each (approx. €1,020)
Multiple Nonmembers*$1585 each (approx. €1,155)$1685 each (approx. €1,235)

Fees are charged in US dollars. Euro values are approximate.

* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.
** Multiple registration fees require three or more participants from the same company to submit individual registration forms at the same time via fax, mail or email to the RAPS Solutions Center.

Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 8 November 2010 unless meeting capacity is reached; after 8 November 2010, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 25 October 2010
E-mail: acallery@raps.org
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