Having troubles conducting you Benefit – Risk analysis?
With clinical, quality and regulatory specialist and entrepreneur, David R. Rutledge
What is this class about?
Tell the Benefit – Risk story and bring value into the process
This class will be hosted on Teams and the link will be emailed to you after your registration and payment.
Why should I attend?
The word Benefit-Risk analysis is mentioned numerous times in the regulation and guidelines. In this course, David will teach you how to transform the analysis process from “stomach feelings” to tangible parameters. During this session we will present to you:
· Where to find the general regulation giving input to the process of conducting a Benefit-Risk analysis?
· How to run the process and who should attend?
· How to create narratives around the Benefit and Risk determination and analysis?
· Tell the Benefit-Risk story and bring value into the process – use a specific method.
· Learn feedback from the use of the method by the Notified Bodies.
This course will be held
Thursday March 25th, 2021 at 4PM CET
Course Curriculum
Lecture 6
Available in
days
days
after you enroll
Hi, I’m David
I am David R Rutledge, Pharm.D., FCCP, FAHA, and I am an accomplished and results-oriented global consultant for start-ups, venture capitalists, and small to mid-size companies. Before my career in the pharma and medical device sectors, I was a tenured, full professor and department chairman. I had several teaching awards when I was in academia. I love teaching and am so happy you will be joining our fun and exciting class!
What my students think of this course
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"The seminar was very informative and incredibly useful. Also, David Rutledge is a fantastic professional."
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