Regulatory Intelligence
With the world of life sciences changing almost daily, navigating information overload in the pharmacovigilance space and keeping abreast of all relevant regulatory information has become critical — and increasingly difficult — for pharmaceutical companies. New and important information on various drug safety areas can be found in many scientific resources around the world, including government email alerts, e-newsletters, pharmacovigilance/regulatory blogs, professional societies’ websites, scientific events and conferences, regulator’s RSS feeds, public hearings, and advisory committee meetings. A competent and experienced regulatory intelligence group can design a regulatory strategy based on a thorough and continuous analysis of existing and new information coming from these and other sources, allowing organizations to identify relevant regulatory trends, streamline the effort of their internal departments, and become familiar with the hot topics usually quoted by regulatory authorities during inspections.
Regulations/Guidance
- Monitor via Pink Sheet (weekly)
- Monitor via Safety Observer (monthly)
- Monitor RSS feeds from regulators
- Monitor regulatory websites
- Attend PV-related conferences/meetings
Database
- Attend user group meetings to learn about new features and updates
- Participate in testing and validation of new features and updates
- Provide feedback on data tests, requirements, design specifications, new features to software developers
To ensure compliance, Med Communications’ team of pharmacovigilance experts can work through the information overflow to capture the pertinent information based on a company’s business priorities, all while supporting an aligned understanding of applicable requirements. For pharmacovigilance regulatory guidance tailored to your needs, please contact us: 877-477-0977 or https://lnkd.in/dgppiUaE.