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Regulatory Affairs Professionals Society (RAPS), Del Mar, CA
29-30 September 2010
| MONDAY, 27 SEPTEMBER 2010 | | 8:00–9:00 am | Registration and Continental Breakfast | | 9:00–9:10 am | Introduction and Day I Overview | | 9:10–10:00 am | What Is an eCTD for the US? | | 10:00–10:15 am | Refreshment Break | | 10:15–11:45 am | What is an eCTD for Europe and How Does it Differ From US? How is It the Same? | | 11:45 am–12:45 pm | Lunch | | 12:45–2:45 pm | Issues Regarding the Content of an Electronic Submission | | 2:45–3:00 pm | Refreshment Break | | 3:00–4:45 pm | How 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 pm | Questions & Answers - Review of Day I | | 5:00 pm | Adjourn |
| | TUESDAY, 28 SEPTEMBER 2010 | | 8:30–9:00 am | Continental Breakfast | | 9:00–9:10 am | Day II Overview | | 9:10–10:00 am | Best Practices in Use of MS Word and Adobe Acrobat Professional (hands-on) | | 10:00–10:15 am | Refreshment Break | | 10:15 am–12:00 pm | Best Practices in Use of MS Word and Adobe Acrobat Professional (hands-on)
(continued) | | 12:00–1:00 pm | Lunch | | 1:00–2:15 pm | Building the eCTD (demonstration) - Initial Submission
- Lifecycle Management
- Repurposing eCTD for Another Country
| | 2:15–2:30 pm | Refreshment Break | | 2:30–3:30 pm | Breakout Session
Conduct an eCTD Readiness Assessment for a Hypothetical Company and Build Your Findings and Recommendations | | 3:30–4:30 pm | Present Findings and Recommendations from Breakout Session | | 4:30–4:45 pm | Questions & Answers - Review of Day II | | 4:45 pm | Adjourn |
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Organized by:
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Regulatory Affairs Professional Society |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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N/A
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Registration:
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| REGISTRATION FEES | Register by 6 September | Register after 6 September | | RAPS Member | $1495 | $1595 | | Nonmember* | $1680 | $1780 | | 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
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E-mail:
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acallery@raps.org
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