Risk Management in Pharmaceuticals and BioTech


Instructor: Martin Lessem
Product ID: 706325

  • Duration: 90 Min
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.
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Why Should You Attend:

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

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Regulatory Affairs, Quality Assurance

Free Materials:

  • Rule documents or guidance
  • Slide Show
  • Checklist
Instructor Profile:
Martin Lessem

Martin Lessem
Principal Consultant, Lessem Regulatory Consulting LLC

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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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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