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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

	Statistical Analysis
	Two of Dr. Sharlin’s Training Classes
	Class Title	Description
1	Adaptive Design & Bayesian Statistics: New Trends in Clinical Trial Design That Encourage FDA Approval	A discussion of the basics for implementing adaptive design and Bayesian statistical analysis.
2	Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review	A discussion of how to use statistics to improve the design, execution and analysis of clinical trials..