Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Risk Management

Risk management is very important for accomplishing any project and should be developed in the planning stage of the project. A pharmaceutical risk registry can help acts as a central storehouse for all risks identified in the pharmaceutical project. Ideally, the pharmaceutical register should contain information on risk's name, probability, severity, mitigation strategies, risk ownership and risk status such as pending or reviewed.

The registry provides a structure in which all the underlying problems facing the pharmaceutical project team are captured. Necessary actions are then taken to diminish the probability and severity of the identified problems. These pharmaceutical risks may come from several sources such as: resistance to change, failure to deliver pharmaceutical products in time or the pharmaceutical project exceeding the budget.

PharmaDirections routinely manages a risk registry during their development programs. The project manager continually adding new risks while reviewing the existing ones. The risk items are appraised on regular bases by the project team so that actions to lessen or alleviate risks can be taken.