IMA Life at AFI – PDA Italy Chapter

The final version of Annex 1 entered into force on 25 August 2023, with the exception of point 8.123 (freeze drying), which will be effective since 25 August 2024. At last year’s event, changes and new requirements deriving from the need to comply the updated Annex 1 within the established timeframe were discussed.

The challenge, to which the pharmaceutical industry had to respond finding solutions and resources in a short time, include the interpretation of some requirements which have cast some doubts and opened long debates both among industrial representatives as well as within the regulatory agencies.

AFI and PDA Italy Chapter are organizing this new two-day event in Florence, with the aim of analysing the progress and diversified measures that companies have implemented to respond to the quality demands of sterile medicinal products.

Don’t miss IMA Life presentation, in collaboration with Sanofi Anagni, on September 19th at 3:50 PM.

SPEAKERS

Johan de Hoon – IMA LIFE Product Manager

Enrico Capogna – SANOFI Engineering Manager