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Training

Two broad and related areas are addressed here: (1) training of the drug safety staff and (2) training of the other employees in the organization who need to know something about drug safety.

In any organization, there are two broad areas of training required. The first includes the corporate/organizational requirements and includes such things as using the computer systems, corporate ethics, behavior and mission, equality in the workplace, getting along with coworkers, safety in the workplace, filling out needed forms for payroll and benefits, and other corporate level matters that everyone in the organization needs to know. These programs are usually taught to all employees by the corporate-level training group. These are not addressed further here.

The other area of training, discussed in detail in this chapter, involves job-specific drug safety training. Nearly all drug safety groups now have a training function, and many groups now have full-time dedicated trainers whose job it is to handle all the aspects of training and instruction. This group sets up a training system with tailored curricula, depending on the personnel and jobs being trained. Usually a fair amount of customization is required to train the right people on the right things.

For live training, the training group sets up schedules for training and makeup sessions for those who missed the first session. Although they may do much of the training themselves, especially on high-level or more general subjects, the training group will create a roster of subject-matter experts who will be called on to train in highly specialized or technical areas that the trainers cannot teach. The training group works with the quality and compliance groups as well as with the drug safety group to determine which employees should be trained in which areas. They determine which training can be “one shot” and which requires updating or refresher training. Some groups with high turnover require frequent training sessions for new employees (e.g., the sales force), whereas others are often more stable and do not require training sessions as frequently.

The training job may require significant travel if training is done at various sites around the home country or the world. This is particularly true for multinational organizations and those that have employees working at home or off-site. The levels of training for full-time employees versus consultants should also be taken into account. Consultants, part-timers, interim employees, and other non-full-time employees still need training for their jobs. Issues of training of non-English-speaking employees need to be addressed, especially now that English is often required for international communications in drug safety and international business in general.

Much training now is being done as “distance learning,” using electronic resources such as live or recorded webinars, teleconferences, and software that allows personal study at the time and pace that the trainee desires. The training group should have a good understanding of these newer technologies. The use of consulting and outsourcing in the appropriate circumstances should also be considered.

The training group should set up a record-keeping system, both for the training department to document globally who was trained and for employee-specific training files, which usually remain within each employee’s human resources or departmental dossier. Copies of the training materials (e.g., PowerPoint slides) should also be retained in the master file. Thus, during an inspection by the health agency, the training group can demonstrate that training of a particular function (e.g., handling 7-day expedited reports) was done to the appropriate groups (e.g., drug safety, clinical research, regulatory affairs), with the training documentation (slides, handouts) on file. In addition, the training group can go to each employee’s file and show the record, indicating that that employee was trained on this function on this particular date. All of this documentation can be kept electronically.

The training group should work with the departments to be trained as well as with drug safety to prepare a matrix of which employees (by title or function) need which training modules and at what frequency. They should determine which employees, consultants, and interim workers need refresher training even if the standard operating procedures (SOPs) and processes have not changed.

Many companies now have a general corporate policy that requires all employees and agents of the company (including consultants and temporary employees) to report AEs to the drug safety group if they hear about them during and outside of work. This usually refers to marketed drugs and covers such items as when a neighbor or relative casually notes that he or she took your company’s drug XX and had a bad reaction. The policy requires the employee to report the AE to the drug safety group by the next business day with sufficient contact information to allow drug safety to follow up on the report and to get the details of the case. This should be routinely done (with periodic reminders) in all companies with marketed products with an e-mail blast, memo, or company newsletter.

On drug safety issues, it is necessary to train several groups (“feeder groups”) within the company on their duties in regard to sending AEs to drug safety and then the handling and distribution of the cases. Groups that require training include the marketing and sales groups, the legal department, the mailroom staff, the telephone operators, senior corporate management and their administrative staff (who often receive complaint letters addressed to the Chief Executive Officer or President), all clinical research and support groups, medical affairs, the product complaint department, the quality and compliance groups, regulatory affairs, medical information/services, the new business development group, the library, IT and webmasters, and any other groups identified as being involved with AE or safety reports.

Outside groups needing training include clinical or contract research organizations doing work with or for the company as well as all other contractors and outsourcers (e.g., hired sales forces, such as rent-a-reps), investigators doing clinical research who need to report AEs to the company, outside legal counsel, and other business partners who, by contract, need to adhere to the company’s SOPs. This may sometimes be difficult to determine.

As the training needs of the organization increase because of new hires, expansion, and changes in regulations and requirements, it is unlikely that the personnel and travel budget in the training department will increase proportionately. This forces the group to increase productivity and to “work smarter.” There are many ways to do this, including web-based training or simply recording a training session as a video and posting it online with required viewing and some level of assurance that the employee actually viewed the information, such as a test of the material. The issue of testing arises frequently. It is generally accepted that it is not sufficient to simply train people by having them read materials or attend live classroom sessions or one-on-one training. Some determination of whether the material has been absorbed is usually required. This can be done by formal testing at the end of training or at some point after training is completed (e.g., yearly at the same time each year). The testing may be anonymous or the results made known only to the person being tested and not the trainer or supervisor. Retraining and retesting for people who fail may be required. In all cases, good pedagogic techniques must be followed, such as “praise publicly, reproach privately.” The training group typically prepares modules covering each section or subsection listed below and can thus pick out which modules should be used to train which employees as a function of the employee’s job and experience. For example, internal hires may need less training than new hires.

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