RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--Multiple companies surveyed by Cutting Edge Information indicate that they begin outlining risk management plans as early as Phase I.
“Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting”
A recent study, “Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting,” found that preparing risk management plans early helps companies maintain a drug safety perspective throughout the drug development process.
Companies that generate preliminary plans can adjust these strategies as products move through the pipeline. This level of flexibility makes it easier for companies to meet any potential drug safety challenges — including the need for additional, unforeseen drug safety measures — as they arise. Developing risk management plans early enables companies to focus on NDA applications and gaining product approval following clinical trial completion.
Cutting Edge Information’s study discovered that preliminary toxicology and pharmacokinetic data often shape companies’ initial risk management plans. As more data filters in from additional trials, drug companies adjust and expand these plans as necessary.
Specific risk management plans evolve differently from product to product. Companies reported that their risk mitigation activities range from product label adjustments to supplementary educational materials. One interviewed pharmaceutical executive noted that label changes reflect companies’ most frequent means of risk management. Companies’ drug safety data shape a number of details accompanying marketed products, including:
• Adverse event details
As companies continue to build their drug safety profiles, they may need to update these drug labels to reflect new information.
“Outside of labeling, companies may also center their risk management plans upon providing consumers and physicians with additional sources of drug safety information,” said Sarah Ray, research analyst at Cutting Edge Information. “These materials equip audiences with additional drug safety education and guidance surrounding proper use. Common tools include communication plans, medical guides and patient package inserts.”
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 SOPs and social media tools.
Pharmacovigilance teams can use this report to:
- Optimize drug safety budgets and outsourced spending.
- Build a strong pharmacovigilance team and cultivate a drug safety culture companywide.
- Improve efficiency and develop best-in-class practices.
For more information about drug safety programs, contact Cassie Demeter at 919-403-6583.