The pharmaceutical industry is one of the most publicized - and often criticized - components within the health-care sector. Prescription medicines have contributed major improvements to human health and will continue to do so. Regulations and regulatory authorities play key roles in assuring their quality, safety and efficacy. Still, while headlines often feature hope for new treatments arising in research (e.g., Alzheimer's disease), there are also sometimes reports of possible breaches of safety or ethics (consider opioids). How is it that these different aspects can arise within the same industry? Why does it take so long for a new drug to reach patients? Are regulations too strong or too weak? This overview is intended for anyone thinking about working in the pharmaceutical industry or elsewhere in the health-care sector where medicines play a role. The objective is to understand the guiding scientific principles of drug product development and how to find regulatory resources which allow an inside view on the processes involved in arriving at and managing a position on the market.
Lecturer: Dr. Anita Peil
More information: https://www.uni-rostock.de/forschung/mare-balticum-fellowship/events/making-a-medicine-scientific-regulatory-and-ethical-considerations/