Regulatory Risk Management in Pharmaceuticals and BioTech
This course will focus on Risk Management in the Pharmaceutical and BioTech space. It will cover Risk Management Programs and also managing general regulatory risks in the drug development process.
- RiskMAPs and REMS
- Relation of Risk Management Programs to Labeling
- Physical Risk Management in Manufacturing
- Risk Management in Clinical Trials
- Major Risk Management Programs approved by FDA
- Risk Management in Ex-US Territories
- Risk Mitigation vs. Risk Minimization: Benefits of each
- Generics vs. Innovators
Risk Management is a topic which all Pharmaceutical and BioTech companies are required to understand to enable them to work toward mitigating those risks. These risks can be both product related, but also internal to the company with manufacturing risks, risks with Clinical Trials, or other risks related to drug development. This course will examine many of these risks and provide you with a better understanding of them and some tools to help you in mitigating or preventing them.
- Gain a better understanding of Regulatory Affairs and Quality Assurance Roles in Pharmaceutical Risk Management
- Better understand have the FDA has recently been considering Risk Management
- Understand the importance of FDA Communications with regard to Risk Management
- Understand how other departments are influenced by Risk Management and Risk Management decisions
- Regulatory Affairs, Quality Assurance
Martin A. Lessem, J.D. is a professional with 17 years of experience in Pharmaceuticals. In the past 12 years he has been heavily involved with Regulatory Risk Management and worked on many of the larger industry programs. He has worked at large companies, small companies, innovator companies, and generic companies and has worked in risk management in all those settings. Currently, he is a consultant to Pharmaceutical companies on Regulatory Strategy and Risk Management.
Upcoming Webinars
By Harold Levy
Date: April 25, 2024
By Dr. Susan Strauss
Date: April 26, 2024
By Justin Muscolino
Date: April 29, 2024
By Carolyn Troiano
Date: April 29, 2024
By Marcia Zidle
Date: April 29, 2024
By Ben Currie
Date: May 1, 2024
By Audrey Halpern
Date: May 1, 2024
By Pete Tosh
Date: May 1, 2024
By Mary Gormandy White
Date: May 1, 2024
By Diane L. Dee
Date: May 2, 2024
By Jeff Kasoff
Date: May 2, 2024
By Paul J. Cline
Date: May 3, 2024
By Carolyn Troiano
Date: May 3, 2024
By Richard E Cascarino
Date: May 6, 2024
By Marcia Zidle
Date: May 7, 2024
By William J. Rothwell
Date: May 7, 2024
By Edwin Waldbusser
Date: May 7, 2024
By Beverly Beuermann-King
Date: May 7, 2024
By Bob McKenzie
Date: May 8, 2024
By Patrick Haggerty
Date: May 9, 2024
By Don Phin
Date: May 14, 2024
By Margie Faulk
Recorded Session
By Miles Hutchinson
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By Deborah Covin Wilson
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By Donna K Olheiser
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By Catherine M. Mattice
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By Neil Malek
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By Deborah Covin Wilson
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By Ray Graber
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By Janette Levey Frisch
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By Paul J. Sanchez
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By Catherine M. Mattice
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By Danielle DeLucy
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By Lisa Marsden
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By E. Pete Lewis
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By Mike Thomas
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By Deborah Covin Wilson
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By Jeff Kasoff
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By Candace Curry Leuck
Recorded Session
By Loren Gelber
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By Rebecca Staton-Reinstein
Recorded Session
By Marcia Zidle
Recorded Session
By Paul R Hales
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By Paul J. Sanchez
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By Margie Faulk
Recorded Session
By Deborah Covin Wilson
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By Lisa Marsden
Recorded Session
By Michael D Haberman
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