Clinical Trial Ethics - Right, wrong and the grey area in between
Dr. Joy Frestedt, PhD, CCTI, RAC, FRAPS
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- Introductions - 15 Min
- Session 1: Language of Ethics Understanding the fundamental concept - 45 Min
- Code of Ethics
- Overriding Challenge
- Session 2: Situational Ethics with Clinical Trials - 60 Min
- Driving forces
- Researching and identifying components and stakeholders
- Ethically sensitive perspective
- Company culture and tolerance
- Break - 30 Min
- Mini Case Studies: Clinical trial ethical dilemmas - 75 Min
- Lunch - 60 Min
- Session 3: Systematic Appr - 45 Min
- Risk based approach
- PLUS Tool
- Buddy approach
- Break - 30 Min
- Case Study: Analyzing ethical situations systematically - 75 Min
- Session 4: Ethics and Regulatory requirements - 45 Min
- New models
- Modified approval processes
- Hot ethical topics
- Day 1 Recap - 15 Min
- Session 5: Ethical Leadership - 60 Min
- Personifying ethical leadership
- Leadership versus Authority
- Influencing others
- Revising corporate culture
- Corporate Round Table: Open forum to discuss ethical issues participants may have - 45 Min
- Break - 30 Min
- Workshop: Developing a corporate code of ethics and culture change implementation plan 45 Min
- Q&A and Conclusions - 45 Min
Meet Your Instructor
||Dr Joy Frestedt
President and CEO of Frestedt Incorporated
Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson's Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.
Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.
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Course "Clinical Trial Ethics - Right, wrong and the grey area in between" has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.
Regulatory Affairs Certificate Program (By Regulatory Affairs Professionals Society RAPS)
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