Submission Survival Series: Navigating FDA Data Requirements- SD, LA, Bay Area presented by Accenture

Date
Location
Biocom offices: SD- LA- Bay Area

Getting your submission right the first time, within budget, is a strategic imperative for your organization. Without a clear and compliant clinical data strategy, many companies will struggle during the submission process.

The interactive discussion will include up-to-date information to better prepare your company for the rigors of organizing your clinical data packages in accordance with current guidance.

Join Accenture Clinical Data Operations Director, Brian Hermann, and Intelligent Data Flow (IDF) Operations Lead, George Stuts, for the Submission Survival Series: Navigating FDA Data Requirements. The 2 hour seminar will review how to plan for your clinical data submission readiness within Module 5.

Please choose a location from the list below that best suits your needs.

San Francisco
Tuesday, October 16, 2018
11:00 am - 1:00 pm
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Los Angeles
Wednesday, October 17, 2018
11:00 am - 1:00 pm
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San Diego
Thursday, October 18, 2018
11:00 am - 1:00 pm
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​​​Topics will include:

CDISC
Recent binding guidance from FDA (effective Dec 2016)
Waivers
Exemptions
Timelines
Study Data Technical Conformance Guide
Study Data Standardization Plan
Data Traceability and the FDA
Define files
Reviewers guides
Annotated CRFs
Pinnacle21 Data Validation
Coding
Pooling
Submission Timelines

Who should attend:
Both early-stage companies who are new to the clinical data submission guidance’s, and portfolio builders who want to enhance their current clinical data submission knowledge, will benefit from attending the seminar.