The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.
On May 20, 2019, the European Medicines Agency (EMA) announced that it updated the European Union list of recommendations for the influenza virus strains that manufacturers should include in vaccines for the prevention of seasonal influenza starting in autumn 2019.
The recommendations contain a decision on suitable H1N1 and H3N2 viruses for seasonal live attenuated influenza vaccines (LAIV). The list of reagents for vaccine standardization has also been updated.
Details such as the specific virus strains to be included are available in the updated 2019/2020 recommendations, which were issued by EMA's Biologics Working Party ad-hoc Influenza Working Group. The ad-hoc Influenza Working Group initially made recommendations for the 2019/2020 flu vaccines on April 1, 2019 and first updated its recommendations on April 10, 2019. The list is developed on the basis of recommendations by the World Health Organization.
Applications to change the composition of centrally authorized flu vaccines are due by June 17, 2019.
Source: EMA
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.