Drug Companies Lack Budgets for External Compliance Training

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Although compliance to regulatory guidelines is a critical responsibility for life science companies, they spend little time and budget training their vendors, finds a recent report by Cutting Edge Information.

“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing”

According to “Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” training external vendors, agencies, CROs and other third-party providers accounts for only 3% of compliance teams’ budgets and just 1% of their time. By comparison, internal employee training takes up 9% of the compliance team’s budget and 10% of the team’s time.

Instead falling to the compliance team, external training may be the responsibility of the functions contracting services. For example, a marketing team may provide compliance training on adverse event reporting to an agency whose services it requires for a specific branding campaign.

“Non-adherence costs the pharmaceutical industry billions each year in fines and other punitive measures,” said Ryan McGuire, research team leader at Cutting Edge Information. “Internal regulatory compliance training companywide is vital to avoiding such consequences, but companies should also consider extending compliance teams’ training of external audiences. Compliance groups have the most expertise and knowledge in making sure that outsourced efforts strictly adhere to regulatory guidelines.”

Experience is a key factor that determines how much training a compliance team conducts. For example, a new employee hired to do a largely technical job may require eight to ten training units. A veteran at the company, on the other hand, may need only two training units. Similarly, a new hire placed in a strategic role could need 20 to 30 training units. But a longtime employee may need only half as many or refresher courses.

“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” (http://www.cuttingedgeinfo.com/research/regulatory/compliance/) investigates the modern compliance landscape within the pharmaceutical industry and provides key benchmarks on how companies allocate money, staff and support to compliance teams. It also includes data on what compliance teams struggle with most under an increasing and difficult workload. The report guides decision makers to:

• Improve compliance training and eliminate outmoded, ineffective means for delivering training.
• Strengthen the compliance team’s role and clearly separate it from regulatory affairs.
• Centralize oversight under a compliance umbrella — while empowering specialists to do ground-level work within a matrix structure.

For more information, contact Cassie Demeter at [e-mail] or [phone].