The Importance of Protecting PI’s Prior to Launch

In the medical field, the package insert (or PI) is the most crucial component of a product launch. This is because the PI contains necessary information, including the description, indications and usage as approved by the FDA, warnings, precautions, dosage and administration and how the medication will be supplied. The information contained within the PI allows all departments that are linked to the product launch to develop necessary materials needed for the product launch.

The Problem with Limited and Delayed Access

Unfortunately, aside from the marketing team of life science companies, access to the contents of the PI are highly guarded. This means that other departments associated with the product launch, such as the training, demand planning and analytics staff members, are given very little time to create materials before the launch meeting takes place. Often, they have only a few short weeks to prepare an entire product launch and required e-learning materials.

This is generally done purposely as a precaution to decrease the risk of vital data being leaked to competitors or to prevent information from being discussed by pharmaceutical sales representatives before the product is officially approved. While this is a common practice throughout the medical field, it presents a dilemma for those who are not granted access to the information that they need to perform their jobs thoroughly.

Upon receiving the PI, they must must quickly rush through the creation of these materials, which can increase the risk of avoidable errors and decrease the quality of the materials due to time constraints. Likewise, it leads to a stressful and frustrating experience for the employees affected. While they must create required materials in an unrealistic span of time, they also feel that there is a lack of trust and a lack of collaboration between departments.

How to Minimize the Risk of PI Leaks

The key to enabling all departments and staff members of life science companies to aid in a successful product launch lies in both effective internal communication and a strong data leak prevention plan (DLP). While there is no denying that it is necessary to protect sensitive data surrounding a new product, measures can be taken to decrease the risks of sharing this information among relevant employees:

1. Determine Who Needs Access to the PI

Everyone employed at a life science company will certainly not have the same need for the guarded data contained within the PI. First, determine who has a relevant need for the protected information beyond the marketing team. Members of the customer service team, for instance, may not need access to this information before the launch. From there, relevant departments can be examined to determine which staff members will benefit the most from earlier access.

2. Limit User Privileges and Personal Devices

From there, user privileges can be set and monitored. If not all aspects of the PI are required for an employee to do their job, only share the information that is needed. They should be made aware of their status and advised that they are viewing confidential information. Non-disclosure agreements (NDA) should be signed and companies should have a BYOD (Bring Your Own Device) policy in place. By restricting access to protected devices, they can ensure that the security features on devices containing sensitive data meet company standards.

3. Educate Employees

Cybersecurity is a big concern for all businesses in life sciences. To decrease risks of phishing attacks or other careless mistakes, which may inevitably lead to a leak of PI information, educate employees. Many employees simply may not be able to identify a phishing scam without proper training.

4. Encourage Collaboration Between Departments

If an employee with limited access privileges has a question regarding content within the PI, encourage collaboration between departments. There are ways for a more knowledgeable employee to answer questions and share helpful information without releasing the full PI to those with limited involvement before the launch.

It is also important to note that not all leaks of important information are malicious acts performed by disgruntled employees. Many are simply avoidable errors that can be prevented by educating employees. By taking a few added precautionary steps, life science companies can begin to trust their employees with confidential PIs. In turn, this will allow for increased productivity, better and more thorough product launches and enhanced employee morale.

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