RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--To ensure that pharmacovigilance activities run smoothly, drug companies are stepping up training to all drug safety-facing functions, finds a Cutting Edge Information study.
The study, “Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting,” discovered that many groups — from medical affairs teams to sales teams — report pharmacovigilance responsibility. Providing adequate education to all functions on pharmacovigilance activities is an industry-wide best practice.
One interviewed pharmaceutical company’s dedicated pharmacovigilance team develops training modules for the company’s new hires. Through brief presentations, the company’s drug safety team apprises new team members of the criteria behind adverse event identification. New hires must then undergo a second educational course. Finally, the studied company confirms its teams’ knowledge through a required, short test following the training series. Likewise, the team also provides the necessary training for its associated vendors and consultants — as well as its sales group on a biannual basis.
To ensure prompt case management — including timely adverse event reporting — the interviewed company’s pharmacovigilance head developed a timeline to track companies’ incoming and outgoing case reports. Although companies have 15 days to submit serious adverse event reports to the FDA, this company expects its team to send out information by Day 10. The earlier the drug safety team completes its case management activities, the more time affiliate groups have to submit data to their regulatory authorities.
To ensure teams uphold this schedule, the interviewed company’s pharmacovigilance head frequently communicates with its pharmacovigilance and sales teams. In the event the company’s field force fails to deliver adverse reports within the initial required 24-hour reporting period, this pharmaceutical executive personally follows up with the responsible parties. By maintaining ongoing communications across its dedicated teams, companies address reporting challenges early and are able to develop protocols to prevent future delays.
The data in “Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting” (http://www.cuttingedgeinfo.com/research/regulatory/drug-safety/) are designed to assist in companies’ drug safety efforts and elevate pharmacovigilance teams’ strategic impact through well-defined standard operating procedures and social media tools.
Pharmacovigilance teams can use this report to:
- Optimize drug safety budgets and outsourced spending.
- Build a strong team and cultivate a drug safety culture companywide.
- Improve efficiency and implement best-in-class practices.
For more information about drug safety programs, contact Cassie Demeter at 919-403-6583.