Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA Regulatory Consultant (25 Years)
Expert Witness (10 Years)

My 40 Classes

My vast teaching experience allows me to present complex information in plain words to a judge and jury. Over 50,000 people from more than a thousand FDA regulated companies have paid to hear the 40 classes I developed and taught.

Note: each bullet point is a class title. Classes are a 60 minute presentation using a 50-75 page handout.

Understanding FDA Reviewers and the Review Process

  • What Needs to Be in a Product Submission – An FDA Reviewer’s Perspective
  • FDA’s Financial Disclosure Guidance for Clinical Investigators
  • Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, & Techniques for Approving Your Submission
  • Good Review Management: FDA’s Internal Standards and Expectations of Industry
  • Disagreeing With FDA: A Shot in the Arm or a Shot in the Foot?

FDA Requirements for Reports, Labels and Advertising

  • Annual Reports: Standard Operating Procedures for Developing Content That Meets FDA Requirements
  • Understanding FDA’s New Package Insert Requirements for Drugs and Biologics
  • FDA’s New Guidance and Enforcement: Company Web Sites, Email & Online Advertising

The FDA Database:

  • Submitting Clinical Trial Data: FDA Requirements
  • FDA Requirements for Entering Clinical Trial Results into
  • Certification of Compliance
  • What’s an “applicable Clinical Trial”?

Clinical Trials Conducted Outside the U.S.

  • No More Form 1572s – A New Regulatory Strategy for Faster & Less Expensive Global Clinical Trials
  • Foreign Clinical Studies: New FDA Regulations

How to Analyze Trial Results – Help for Non-Statisticians

  • Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review
  • New Trends in Clinical Trial Design That Encourage FDA Approval
  • Adaptive Design: Why is FDA so Enthusiastic?

SAS Programming

  • Understanding SAS Programming Internals, Part 1
  • Understanding SAS Programming Internals, Part 2
  • Standard Operating Procedures for SAS Programming: Tools for Part 11 Compliance
  • Testing SAS Programs: A Key Element of Part 11 Compliance
  • Using Available Tools: How to Reduce Part 11 Compliance Costs for SAS Installation, Maintenance and Programming

Part 11 Electronic Record Compliance and Software Validation

  • Auditing Information Systems: Are You and Your Vendors Meeting FDA Expectations
  • Implementing a Risk Based Approach to Part 11 Compliance
  • Computerized Systems Used in Clinical Trials: Improving your Compliance
  • Auditing for Part 11 Compliance: It Hasn’t Gone Away
  • FDA’s New Guidance on Electronic Source Documentation in Clinical Trials

Medical Devices

  • FDA’s New 510(k) Action Plan
  • 510(k)s: The 70 Changes FDA Wants
  • Adverse Event Reporting SOPs for Medical Devices

Safety Reporting for Drugs

  • FDA’s Safety Reporting Requirements: Changes for Clinical Trials
  • Adverse Event Reporting Standard Operating Procedures for Drugs and Biologics
  • FDA’s New Safety Reporting Requirements: Complexities and Costs

How to Write Standard Operating Procedures (SOPs)

  • Writing SOPs Part I: An Introduction
  • Writing SOPs Part II: Advanced Problems, Advanced Solutions
  • SOP on SOPs

Improving the Analysis and Presentation of Study Results

  • A New FDA Environment: It’s Time to Examine Your Clinical Trial Analysis Data Sets
  • Implementing FDA’s Guidance on the Integrated Summary of Effectiveness (ISE)
  • Clinical Information Strategy

Generic Biologics

  • Report on FDA Meeting About Follow-On Proteins (i.e., Generic Biologics))