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Legal and Compliance Hot Topics: “Data Integrity: What it means”
August 5 @ 12:00 pm - 1:00 pmFree
Legal and Compliance Hot Topics:
“DATA INTEGRITY: WHAT IT MEANS”
August 5th, 2020
12:00 pm – 1:00 pm
Complementary to OCRA Members
Hot Topics No. 4: Data Integrity: What it Means
In this month’s meeting we will be joined by Jamie Colgin, President, Colgin Consulting, Inc. Jamie Colgin will talk about roles and responsibilities in clinical trials including data integrity attributes and what it means to clinical investigators and companies. We will explore where things can go wrong and how the FDA evaluates clinical trial data.
Discussion Chair, Virginia A. Suveiu, Esq., Counsel at Volkov Law Group will provide answers to the legality and questions about privacy of data.
- Where Things Can Go Wrong
- Data Integrity Attributes
Please be prepared to take notes, as there will be no slides or recording of this presentation available
Each month we will select a Hot Topic and request for input on questions, scenarios, and topics to be covered. Please send ideas and general questions to: [email protected]
This is the fourth of a continuing forum that primarily focus on hot topics in the legal and compliance realms, such as: privacy and data security matters; litigation and disputes; malpractice and insurance; contracts in the age of pandemic (e.g., force majeure clauses, Defense Production Act, etc.); product liability; IP; corporate; AI and robotics.
This forum will be complimentary to OCRA Members.
- OCRA Members and Government: Free
- Non-Members: $75 with one-year registration or $35 for students or government employees (Event will be free)
Jamie Colgin is the President of Colgin Consulting, Inc., a consulting firm that helps Pharmaceutical, Biopharmaceutical, and Contract Research Organizations assure the integrity of their clinical data through Data Integrity Audits, Mock Inspections, Remediation Assistance, and Training. With over 20 years of hands-on experience in statistics, computer system validation, audits, and monitoring, Jamie has developed validated SAS programs to support GLP studies, managed the retrospective evaluation of hundreds of GLP and GCP systems, written policies and procedures, and set new standards for communicating audit findings by using process flow diagrams. Recipient of the prestigious Charles H. Butler Excellence in Teaching Award, Jamie can provide training for your audit staff focused on updating skill sets and understanding regulatory trends. Prior to working in the pharmaceutical industry, Jamie proudly served with the US Peace Corps in the Philippines. She credits this experience for her resourceful nature and ability to make connections colginconsulting.com . Contact info: [email protected]
Professor Virginia A. Suveiu, Esq., is Of Counsel at Volkov Law Group. She is currently editing a handbook on Risk Management and the Law for Routledge. Virginia is a mediator and arbitrator for the International Chamber of Commerce, the Orange County Bar Association and the Financial Industry Regulatory Authority. She is on the Board of Directors of the National Contract Management Association-Orange County. She is affiliated with and has been invited to speak to several professional organizations on business law-related issues. She is an active member of the State Bar of California and admitted to the U.S. District Court, Central District of California. Virginia has held numerous positions in academia, including as founding dean and professor, and currently, she is an instructor and content developer for UC Irvine and was given with the Distinguished Instructor Award there. Virginal is an instructor & content developer at UCI. Contact info: [email protected]
OCRA’s non-profit Federal Tax ID# 33-0630455
If you have any questions or require additional information, email OCRA Program Chair ([email protected])
Location: Online Event
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