Expert Details

Expert in FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity

Expert ID: 732460 Maryland, USA

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Skilled at writing expert reports that describe and explain regulatory and compliance-related issues
involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing
drug/medical device-related safety data and FDA compliance information to answer three questions:
1) What did the company know and when did they know it? 2) What should the company have
known and when should they have known it? 3) What should the company have done and when
should they have done it?
Contributed as an FDA regulatory expert witness in cases involving death and injury caused by drugs and medical devices, size of monetary awards, insurance claims, patents and merger contracts.
www.SharlinConsulting.com
410-231-8900 (mobile)

Expert may consult nationally and internationally, and is also local to the following cities: Washington, D.C. -

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Education

Year Degree Subject Institution
Year: 1981 Degree: PhD Subject: Physiology Institution: University of Georgia
Year: 1976 Degree: MS Subject: Physilogy Institution: University of Maryland
Year: 1973 Degree: BS Subject: Zoology Institution: Univerity of Iowa

Work History

Years Employer Title Department Responsibilities
Years: 1994 to Present Employer: Undisclosed Title: President Department: Responsibilities: Expert serves as an FDA compliance expert, trainer, SAS programmer, statistician, technical writer, and auditor. He utilizes his authority on auditing, writing NDAs, PMAs, protocols and SOPs. He also employs his expertise in validation and 21 CFR Part 11 compliance.
Years: 1992 to 1994 Employer: Food and Drug Administration Title: Drug Reviewer Department: Responsibilities: Managed the drug review process. Instructed firms on how to proceed with drug approval. Summarized outstanding problems and issues with protocols and studies, and determined if deficiencies were adequately addressed. Reviewed statistical methodology of studies. Authored all written communication to the sponsoring firm and integrated comments from other reviewers. Developed techniques to evaluate submission data quality.
Years: 1989 to 1992 Employer: Marriott Hotels Title: Director of hotel Customer Information systems Department: Marketing Responsibilities: Managed a team of 25 programmers responsible for building the system supporting Marriott Hotel’s Rewards program

Government Experience

Years Agency Role Description
Years: 1992 to 1994 Agency: Food and Drug Administration Role: Drug Reviewer Description: Expert managed the drug review process. He instructed firms on how to proceed with drug approval. He also summarized outstanding problems and issues with protocols and studies, and determined if deficiencies were adequately addressed. Expert reviewed statistical methodology of studies. He authored all written communication to the sponsoring firm and integrated comments from other reviewers. He developed techniques to evaluate submission data quality.

Additional Experience

Expert Witness Experience
He is an expert in searching the medical literature for all safety-related information about an FDA-regulated product. His specialties include building timelines to describe how and when the knowledge base about a product increased, and to explain the development of new conclusions about a product’s safety. He is skilled at answering three questions: What did the company know and when did they know it? What should the company have known and when should they have known it? What should the company have done and when should they have done it?

Expert has supported plaintiff attorneys with FDA regulatory information and insight in cases involving Actos, Fentanyl Sulindac and defective hip implants.
Training / Seminars
Expert has developed training for scientists in computerization and analysis of data. He created and taught instructor-led classes in SAS validation and FDA compliance. He wrote and taught over 40 different audioconference classes on a wide variety of FDA regulatory, technical and compliance topics attended by over 50,000 people from FDA regulated companies. He has taught FDA compliance to students in India using Skype.

Audioconference Topic Number of Presentation Titles
1 Part 11 Compliance and Software Validation 5
2 The FDA Database: ClinicalTrials.gov 4
3 How to Write SOPs 3
4 Clinical Trials Conducted Outside the U.S. 2
5 Understanding FDA Reviewers, Compliance and the Review Process 5
6 Safety Reporting for Drugs 3
7 Improving the Analysis and Presentation of Study Results 3
8 FDA Requirements for Reports, Labels and Advertising 3
9 Biosimilars 1
10 How to Analyze Trial Results - Help for Non-Statisticians 3
11 SAS Programming 5
12 Electronic Submissions 5
13 Medical Devices 3

Fields of Expertise

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