Regulatory Affairs in Animal Health Seminar Series
K-State Olathe is hosting seminars designed to provide hot topic information in regulatory affairs and connect industry with regulatory agencies.
Seminar 4: "Data Management for Animal Health Studies"
June 7 | 1-5 p.m.
Whether you have a formal data management group or the function is built into your other roles and processes, data management has become a vital part of regulated research. It touches on all processes from protocol development through submission, and helps to ensure data quality and integrity. This seminar will discuss the critical aspects of data management through the unique perspective of animal health.
The session will provide discussion on the following topics:
- Data Management Elements
- Using Raw Data in Studies
- Contents of a Data Management Plan
- Data Management Considerations in EDC Study Setup
Registration is $100 per person.
Seminar Honorary Chair
Bayer Animal Health
Damon Bradley has been the data manager for Bayer Animal Health, North America for five years.
He has been involved in pharmaceutical research for over 20 years. He is currently the vice-chair for the Society of Quality Assurance Animal Health Specialty Section and the co-chair for their Electronic Data Capture (EDC) Working Group, which is investigating issues and solutions unique to animal health regarding EDC.
Bradley has a M.S. in biology, and is a Registered Quality Assurance Professional – Good Laboratory Practice (RQAP-GLP).
Senior Clinical Data Manager
Deborah Eyer Garvin, MS, RQAP-GLP is currently the GLP/GCP manager of Huvepharma Inc., an Animal Health Company headquartered in Bulgaria.
She has been involved in regulatory research since 1986 and was President of Pacific Rim Consulting and West Coast Quality Training Institute from 1992-2015, providing training and consulting in FDA, EPA and OECD GLPs and FDA CVM GCPs.
In January 2015, Garvin closed her consulting business to take a job with CVM FDA establishing Quality Assurance Study Review policies and processes, now known as the QASR group. She left that position in June 2017 to join Huvepharma.
President and CEO