ComplianceOnline, Online Webinar
2012-07-26
Why Should You Attend: This presentation discusses the high risks of scientific misconduct in regulated studies. It distinguishes between large and small errors in misjudgment and how QA professionals manage these occurrences. It also describes a plan for ensuring the highest ethical standards in your lab. The webinar begins by giving a brief introduction to terms related to regulatory action, such as “fraud,” “misconduct,” “injunction,”, “disqualification,” etc. It describes the root causes of scientific misconduct. These root causes are discussed with special attention to the various individuals most likely to make these errors in judgment. Thus, the webinar covers ethical behavior with respect to sponsors, testing facility management, study directors, study scientists, regulatory affairs professionals, and quality assurance professionals. The webinar then summarizes the main warning signs of scientific misconduct from the perspective of regulatory agencies and auditors. This discussion covers “red flags” in raw data, reporting, and the sponsor-CRO relationship. Areas Covered in the Seminar: - How to recognize fraud and scientific misconduct
- Why scientific fraud and misconduct happen
- What are the warning signs of scientific misconduct?
- How QA professionals can spot scientific misconduct
- How to develop a plan for identifying high-risk situations
- How to analyze a case of possible scientific misconduct
- What is the role of QA professionals in scientific integrity
- What are the risks of scientific misconduct?
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Invited Speakers:
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Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations
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