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.
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.
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. FDATrainingAlert 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.
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