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Additions to SpeedUpFDA.com

Overview 10Sep09, FDA-Internet 22Sep09, Internal FDA Standards 24Sep09, AE Reporting for Drugs & Biologics 8Oct09, AE Reporting for Devices

Overview Building better FDA submissions--

Mission Statement Seven Benefits when Hiring Dr. Sharlin Training Experience Resume

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

View This Month's Training Classes Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

In Progress

	ClinicalTrials.gov Reporting
	Four of Dr. Sharlin’s Training Classes
	Class Title	Description
1	Understanding the Requirements for Entering Protocol Data into ClinialTrials.gov	Understanding the new requirement to enter study protocols data into the ClinicalTrials.gov web site.
2	Understanding the Requirements for Entering Clinical Trials Results into ClinialTrials.gov	A discussion of the requirements of all FDA regulated companies to enter clinical trial results into www.CinicalTrials.gov
3	Implications and Key Points About the Certification of Compliance	A 30-minute update discussing FDA’s requirement for submissions to include a Certification of Compliance (Form FDA-364) confirming that protocol information has been entered into www.CinicalTrials.gov.
4	FDA’s New Definition of an “Applicable Trial”	A 30-Minute Update that reviews the content of FDA’s December 8, 2008 document intended to explain the agency’s interpretation of an “applicable clinical trial”, a study whose protocol and results must be entered into ClinicalTrials.gov