Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy – Webinar Recording/Transcript
What you don’t know about statistics and data will hurt your legal and policy positions. Even your FDA submissions.
This presentation designed for regulatory professionals and attorneys will empower you to use simple techniques to harness such information and use it to your advantage.
Aduhelm (aducanumab), Exondys 51 (eteplirsen) and generic acyclovir cream … most important FDA regulatory decisions are based on cutting-edge interpretations of data, information and evidence from product performance studies that are controlled using statistical methods.
When you understand the reliability and weight of evidence from product performance studies, you can develop successful positions. This webinar will show you how to do just that.
You’ll discover the evidentiary value of product performance study results concerning efficacy, safety, bioequivalence and other issues. And you’ll learn to use these simple techniques to develop, interpret and advocate product performance evidence in regulatory and legal matters.
Using the legal and scientific methods he developed over 30 years, Baker & Hostetler partner Lance Shea will share his straightforward framework and methods so you can use statistics and data to your advantage.
- Assess the reliability of data, information or evidence and the weight they provide for regulatory or litigation decisions
- Evaluate the persuasive strength of such data, information or evidence
- Direct the development of evidence to support requests for or responses to regulatory actions
- Guide the advocacy of product performance evidence to address regulatory, litigation and policy issues
- Understand the common pitfalls in developing and interpreting product performance evidence — and how to avoid them
This presentation is crucial to your understanding and harnessing of the reliability and weight of evidence for product performance studies. Development of successful positions — and even obtaining product approvals — depends on it.
Meet Your Presenter
Using legal and scientific methods that he has developed over 30 years, Baker & Hostetler partner Lance Shea handles legal matters that require development, interpretation or advocacy of scientific evidence — primarily evidence of product efficacy, safety or bioequivalence. The differentiating feature of Mr. Shea’s practice is that he develops an in-depth understanding of the relevant scientific evidence before crafting legal strategies and positions. He represents clients such as innovator drug, medical device and biotechnology companies. Matters span regulatory (e.g., FDA, FTC, EPA) and litigation forums (e.g., federal and state courts, other tribunals). Additionally, he advises clients on the development of evidence needed to maximize marketing exclusivity and market share for medical products — a process that spans entire product lifecycles.
Who Will Benefit
- Management executives
- R&D executives/specialists
- Regulatory compliance executives/specialists
- Product marketing/advertising executives/specialists
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Feb. 16, 2022