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Regulatory Affairs Professionals Society, Rockville, MD
28-29 March 2012
| Wednesday, 28 March 2012 | 8:00–9:00 am | Registration & 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 am–11:45 pm | What is an eCTD for EU and How Does It Differ From US? How Is It the Same? | 11:45–12:45 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
| 3:30–4:30 pm | Questions & Answers Review of Day I |
| Wednesday, 28 March 2012 | 8:00–9:00 am | Registration & 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 am–11:45 pm | What is an eCTD for EU and How Does It Differ From US? How Is It the Same? | 11:45–12:45 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
| 3:30–4:30 pm | Questions & Answers Review of Day I |
At the conclusion of this workshop, participants should be able to: - Identify fundamental strategies for preparing eCTD submissions
- Explain how eCTD differs from previous electronic submission formats and the technical requirements of an eCTD submission
- Discuss the content of the technical modules and demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
- Submit a US eCTD that is compliant with CDER requirement, as well as an EU eCTD
- Facilitate the transition to electronic submissions within your organization
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Organized by:
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Regulatory Affairs Professionals 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’s 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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21 March
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Registration:
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| REGISTRATION FEES | Register by 6 February | Register after 6 February |
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| RAPS Member | $1,495 | $1,695 | | Nonmember* | $1,720 | $1,920 | | Multiple Members** | $1,395 each | $1,595 each | | Multiple Nonmembers* | $1,620 each | $1,820 each | | Government/Nonprofit Member** | $995 each | $1,195 each | | Government/Nonprofit Nonmember** | $1,220 each | $1,420 each |
Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 21 March 2012 unless meeting capacity is reached; after 21 March 2012, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.
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E-mail:
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raps@raps.org
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