2020 was an unprecedented year for the pharmaceutical industry, where companies were racing against time to bring a safe and effective vaccine for COVID-19 globally. Similarly, there are dynamic changes in the regulatory landscape like BREXIT in EU & MHRA, combination product guidance in the US, guidance from Health authorities like EMA & USFDA on the handling of COVID-19 treatment drug & other medicines during the pandemic.
These events have impacted the global pharmacovigilance (PV) landscape and introduced new risk factors in the existing process, which is required to align with new health authority (HA) requirements. A thorough introspection is needed to identify and manage the critical PV process. In this webinar, we will discuss about preparation and successful PV inspection strategy in the backdrop of COVID-19 and BREXIT.
Following this webinar, participants will be able to:
- Understand health authority expectation in managing compliance during pandemic and transition to normal PV operation post-COVID
- Perform gap analysis for the PV system to identify and mitigate the risks
- Identify alternative procedures to enhance audit delivery and inspection outcome
- Learn about best practices for operational risk management that result in positive inspection outcome