Risk Management in the Pharmaceutical Industry
ISO 31000 guidelines, developed and published by the International Organization for Standardization [ISO], provide a highly universal framework for risk management in various enterprises. The framework includes repeating cycles of design, implementation, evaluation, improvement, and integration executed with leadership and commitment (ISO, 2018). This framework is meant to be closely integrated with the risk management principles based on value creation and protection and risk management process including assessment and treatment (ISO, 2018). Still, while ISO 31000 is fairly universal in its general outline, risks differ from one industry to another, meaning that management frameworks have to adapt to the needs of specific areas.
The pharmaceutical industry has several characteristic features that impact risk management in this sphere. First of all, one thing I soon learned working in this sphere is that the main risks in the industry are not operational but external. It is a natural consequence of the heavily regulated industry, and the most notable among these risks are regulatory decisions about product registration and re-registration (Godmanis, 2019). At the same time, certain aspects of operational processes may also pose a significant risk to the functioning of a pharmaceutical enterprise. Lack of heredity in operational planning is particularly notable in this regard (Godmanis, 2019). To manage external risks, organizations have to account for them with special caution in the design phase. Ensuring that the framework is cyclic and the design of new measures always stems from the improvement and integration of the previous ones, as recommended by ISO 31000, is crucial for heredity in operational planning.
Godmanis, I. (2019). Multidimensional risk management in pharmaceutical enterprises. In proceedings from Turiba University International Scientific Conference (p. 280). Riga, Latvia: Turiba University.
International Standardization Organization [ISO]. (2018). Risk management – guidelines. Web.