The world is witnessing short-term and long-term effects due to COVID-19 while European countries are additionally burdened with BREXIT-driven regulatory obligations.
While health authorities worldwide are releasing guidance to ensure risk proportionate approach-based pharmacovigilance for safety information processing of the COVID-19 treatments, pharmaceutical companies are struggling to integrate digital transformation solutions with regulatory compliance management, safety analysis of Advance Therapy Medicinal Products (ATMP) for inspection readiness. Interpretation of regulatory requirements and addressing new process gaps have become the need of the hour.
Read our whitepaper to learn about:
- Impact of COVID 19 pandemic on pharmacovigilance process
- New challenges in the pharmacovigilance process
- Solutions to achieve compliance with new regulations