Ethical Issues Related to Drug Safety Monitoring, Pricing, and Off-Label Promotion
Life science companies have ethical responsibilities beyond compliant advertising and promotional activities. Increasingly, manufacturers are being held accountable for the safety of their products once they have entered the marketplace. In addition to reporting issues associated with their products, companies may be required by the FDA to take additional risk mitigation steps. Companies doing business with certain federal programs must comply with pricing rules, but they must also consider the broader ethical implications of the prices they charge for their products, weighing public good against the needs of the organization and future product development. Sales professionals must also be familiar with their companies' policies on the issue of off-label promotion - what they can and cannot do when a prescriber asks about using a medicine for an indication not specifically approved by regulatory authorities. This module examines regulatory and industry response to these issues.
Who should attend?
Pharmaceutical sales professionals
1. Describe ethical and regulatory obligations related to the task of pharmacovigilance.
2. Describe ethical issues regarding pricing of medical products, and life science industry responses to them.
3. Describe regulatory restrictions on off-label promotion of medical products.
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About CMR Institute
Through our extensive online blended learning library CMR Institute helps pharmaceutical, medical device and diagnostic professionals maximize market access, connect effectively with decision makers, and demonstrate the value of their products and services. Founded by a team of visionary physicians...
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