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Sheraton Philadelphia Downtown Hotel

May 11, 2015 1:00 PM - May 13, 2015 5:00 PM

201 North 17th Street, Philadelphia, PA 19103

eRegulatory and Intelligence Annual Conference

Agendas

Day 1 May 12, 2015

8:30 AM — 10:00 AM

Session 1 Track 2: Preparing for the New Module 1 (3.3 Format)

10:30 AM — 12:00 PM

1:30 PM — 3:00 PM

Session 3 Track 2: Leveraging Submission, Document & Data Standards for Beneficial Organizational Impact

3:30 PM — 5:00 PM

Session 4 Track 2: eSubmission Collaboration and Considerations for Cloud Solutions

Day 2 May 13, 2015

8:30 AM — 10:00 AM

Session 5 Track 2: A Review of Changes GDUFA Has Brought to the ANDA Process and the Regulatory Business Impact

10:30 AM — 12:00 PM

Session 6 Track 2: eCTD v4 / RPS; So Now We Have a Standard, How Do We Implement eCTD v4?

1:30 PM — 3:00 PM

Session 7 Track 2: Ask The Experts Session

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