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Regulatory Affairs Professionals Society, Washington, DC, USA
2-4 May 2012
| Wednesday, 2 May 2012 | | 12:00 pm | Registration and Lunch | | 1:00 pm | eCTD Overview Antoinette Azevedo, President, e-SubmissionsSolutions.com | | 2:00 pm | Quality (CMC) Content Overview - Module 2-3 Quality Overall Summary
- Module 3 Drug Substance, Drug Product, Regional Information, Appendices
Deanna Murden, president, ePharmaCMC, LLC | | 3:45 pm | Refreshment Break | | 4:00 pm | Safety (Nonclinical) Overview - Module 2-4 Nonclinical Overview
- Module 2-6 Nonclinical Written and Tabulated Summaries
- Module 4 Safety Study Reports and Datasets
TBD | | 5:00 pm | Efficacy (Clinical) Content Overview - Module 2-5 Clinical Overview
- Module 2-7 Clinical Summary
- Module 5-2 Tabular Listing of Clinical Studies
- Module 5 Clinical Study Reports, Case Report Forms, Datasets
TBD | | 6:00 pm | Review of Day 1
Q&A and Discussion | | | | | Thursday, 3 May 2012 | | 8:00–8:30 am | Continental Breakfast | | 8:30 am | Module 4 Datasets, Module 5 Case Report Forms & Datasets TBD | | 9:30 am | eCTD Requirements for the US FDA Antoinette Azevedo, President, e-SubmissionsSolutions.com | | 10:30 am | Refreshment Break | | 10:45 am | eCTD Requirements for Canada TPP Ted Hanebach, Director, Regulatory Operations, Optum Insight | | 12:15 pm | Lunch | | 1:15 pm | eCTD Requirements for Europe Hans van Bruggen, MSc, Senior Regulatory Affairs Consultant and Director, eCTDconsultancy BV and Director, Qdossier BV | | 3:30 pm | Refreshment Break | | 3:45 pm | Regulated Product Submission (RPS) & eCTD Next Major Version (NMV) Jason Rock, Chief Technology Officer, GlobalSubmit, Inc. | | 5:00 pm | Review of Day 2
Q&A and Discussion | | | | | Friday, 4 May 2012 | | 8:00–8:30 am | Continental Breakfast | | 8:30 am | Quality Control and Reviewing Tools for eCTD Submissions Jason Rock, Chief Technology Officer, GlobalSubmit, Inc. | | 9:30 am | Hands-on eCTD Compilation LORENZ Life Sciences Group | | 10:30 am | Refreshment Break | | 10:45 am | Hands-on eCTD Compilation (continued) LORENZ Life Sciences Group | | 12:30 pm | Lunch | | 1:30 pm | Hands-on eCTD Compilation (continued) LORENZ Life Sciences Group | | 3:30 pm | Final Comments & Dismissal |
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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.comTed Hanebach, director, Regulatory Operations, Optum InsightHans van Bruggen, MSc, Senior Regulatory Affairs Consultant and Director, eCTDconsultancy BV and Director, Qdossier BVDeanna Murden, president, ePharmaCMC, LLCJason Rock, Chief Technology Officer, GlobalSubmit, Inc.
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Deadline for Abstracts:
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25 April 2012
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Registration:
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| REGISTRATION FEES | Register by 4 April | Register after 4 April |
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| RAPS Member | $1,635 | $1,835 | | Nonmember* | $1,860 | $2,060 | | Multiple Members** | $1,535 each | $1,735 each | | Multiple Nonmembers* | $1,760 each | $1,960 each | | Government/Nonprofit Member** | $1,135 | $1,135 | | Government/Nonprofit Nonmember** | $1,360 | $1,560 |
* 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. Individuals requesting the government/nonprofit rate must submit their completed registration form by fax or email. Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 25 April 2012 unless meeting capacity is reached; after 25 April 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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