In the gambling world, the number seven is often viewed as lucky, but luck won’t help you prepare for your product’s ongoing safety needs. So, we’ve put together a solid list of seven key questions you should be asking:
1. Is our Pharmacovigilance and Risk Management system ready for product development and launch?
Timing and preparation are critical to successful product development and product launch. With a reliable Pharmacovigilance and Risk Management system in place, you’ll know you’ve done everything you can to get needed data and quality control in order to ensure proper drug surveillance and pre and post marketing success, according to regulations.
2. Are we prepared for the new EU legislation and requirements?
Risk Minimization Strategies in Europe require a customized approach. Manufacturers should consider that products must be reviewed by a variety of regulatory bodies when preparing Pharmacovigilance plans.
3. Are we compliant in writing and submitting our safety regulatory reports?
4. Are we prepared for an upcoming regulatory inspection?
5. Are we efficiently deploying a global solution?
6. Does our product require a Risk Management Plan (EU) or Risk Evaluation and Mitigation Strategy (US)?
The REMS landscape is changing, and designing a REMS program that allows for cost and operational efficiencies is more important than ever.
7. Are we currently working with a vendor who is meeting our needs?
Don’t leave the answers to these questions to chance. UBC has a proven track record of delivering global Pharmacovigilance and Risk Management solutions, and now employs more than 100 Pharmacovigilance professionals in the United States and Europe. Our global solutions, global processes, and multicultural team allow us to serve as a complete safety department for smaller customers, or we can provide any assortment of functional needs for larger companies.
Our Pharmacovigilance services include:
• Process workflow definition and standard operating procedures preparation
• Consultancy in setting up Pharmacovigilance and Risk Management systems
• Safety database setup, validation, hosting, and reporting
• Safety case management (from data entry to reporting to Regulatory Authorities/Ethics Committees/Investigators)
• Medical expertise
• Safety medical writing
• Safety regulatory reporting (Individual Case Safety Reports, Aggregate Reports)
• QPPV (qualified person for pharmacovigilance) role fulfillment
• Communication with Regulatory Authorities
• Signal management
• Regulatory intelligence