If a licence is granted, that is not the end of the process. The sales teams are made up of pharmaceutical sales representatives or medical reps, who promote a selection of the drugs of a pharmaceutical company. The high standards for drug approval in the U.
The most commonly used valuation methods are risk-adjusted net present value rNPVdecision treesreal optionsor comparables. This is equally true in the complex pharmaceutical sector, where many aspects of management come into play, such as strategic management e.
Quality management professionals oversee that all operational departments comply with the recommended best practices, e.
If a compound emerges from these tests with an acceptable toxicity and safety profile, and the company can further show it has the desired effect in clinical trials, then the NCE portfolio of evidence can be submitted for marketing approval in the various countries where the manufacturer plans to sell it.
For some drugs the period of patent protection can be extended for up to a further five-and-a-half years, so long as this does not take the time in which the drug is under patent protection beyond 15 years after the date it received regulatory approval.
Medical affairs focuses on clinical drug development in the post-approval phase and on the medical and scientific aspects of pharmaceutical marketing, such as managing medical communications and publications, key opinion leaders KOLs and advisory boards and medical information answering questions from health care providers and patients.