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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.


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

  • 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

  • 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.

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