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Preparing Compliant eCTD Submissions

  August 18, 2010  
Regulatory Affairs Professionals Society (RAPS), Del Mar, CA
29-30 September 2010

8:00–9:00 amRegistration and Continental Breakfast
9:00–9:10 amIntroduction and Day I Overview
9:10–10:00 amWhat Is an eCTD for the US?
10:00–10:15 amRefreshment Break
10:15–11:45 amWhat is an eCTD for Europe and How Does it Differ From US?  How is It the Same?
11:45 am–12:45 pmLunch
12:45–2:45 pmIssues Regarding the Content of an Electronic Submission
2:45–3:00 pmRefreshment Break
3:00–4:45 pmHow 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
4:45–5:00 pmQuestions & Answers - Review of Day I
5:00 pmAdjourn

8:30–9:00 amContinental Breakfast
9:00–9:10 amDay II Overview
9:10–10:00 amBest Practices in Use of MS Word and Adobe Acrobat Professional (hands-on)
10:00–10:15 amRefreshment Break
10:15 am–12:00 pmBest Practices in Use of MS Word and Adobe Acrobat Professional (hands-on)
12:00–1:00 pmLunch
1:00–2:15 pmBuilding the eCTD (demonstration)
  • Initial Submission
  • Lifecycle Management
  • Repurposing eCTD for Another Country
2:15–2:30 pmRefreshment Break
2:30–3:30 pmBreakout Session
Conduct an eCTD Readiness Assessment for a Hypothetical Company and Build Your Findings and Recommendations
3:30–4:30 pmPresent Findings and Recommendations from Breakout Session
4:30–4:45 pmQuestions & Answers - Review of Day II
4:45 pmAdjourn

Dates: 27–28 September 2010

Discover: San Diego/Del Mar, CA, US

Meeting Location: Hilton San Diego/Del Mar, 15575 Jimmy Durante Blvd., San Diego, CA 92014

Hotel Information: Hilton San Diego/Del Mar is offering a discounted RAPS rate of $149.00 (single or double) through 8 September. Rates are per night, inclusive of breakfast buffet and complimentary wireless in sleeping rooms. Rate per night does not include tax or service charge. Please make your reservation by contacting the hotel directly at +1 800 833 7904 and reference the Preparing Compliant eCTD Submission Workshop for the discounted RAPS rate. The room block is available on a first-come basis and may fill prior to the cutoff, so it is advisable to book your room early.

Discounted Registration Deadline: 6 September 2010

Advance Registration Deadline: 20 September 2010

Onsite Registration Available: No
Please note that capacity for this program is limited. RAPS encourages participants to register early to confirm participation.

Cancellation Deadline 6 September 2010

RAC Points: 12

Will this meeting be recorded?: No

How do I obtain a Certificate of Attendance?
Submit your request onsite to the RAPS Education Program Manager or send a request to education@raps.org after the workshop.

Registration Fees:
$1,495.00 member
$1,680.00 nonmember

More Meeting FAQs »
Organized by: Regulatory Affairs Professional Society
Invited Speakers: Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization 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.
Deadline for Abstracts: N/A
REGISTRATION FEESRegister by 6 SeptemberRegister after 6 September
RAPS Member$1495$1595
Multiple Members**$1395 each$1495 each
Multiple Nonmembers*$1580 each$1680 each
Government/Nonprofit Member***$995$1095
Government/Nonprofit Nonmember***$1180$1280
* 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.
*** To be eligible for the government/non-profit rates, individuals must send the completed registration form via fax, mail or email to the RAPS Solutions Center for verification and processing.

Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 20 September 2010 unless meeting capacity is reached; after 20 September 2010, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 6 September 2010
E-mail: acallery@raps.org
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