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, however 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 a new two-day event in Florence, with the aim of analyzing the progress and diversified measures that companies have implemented to respond to the quality demands of sterile medicinal products.
We are glad to inform you that the final programme is now available.
The workshop formula, which combines the phase of frontal presentations with that of active participation and discussion of the participants divided into working groups, is confirmed.
Representatives from international regulatory agencies and speakers with international and strong knowledge on aseptic processes will share their highly significant experience in the interpretation of the requirements and their planned or ongoing application, giving the working groups inspiration to develop a productive discussion, and will be available to reply to any question coming from the attendees.
All the elements previously highlighted make the event original, extremely interesting and recommend your presence.
Official language: Italian, with course material in English
DOWNLOAD THE FINAL PROGRAMME AND REGISTER NOW
A Webinar introducing the Event will be held on Friday, September 6, with free registration. The Webinar will share the results of the Survey on Annex 1 implementation within the Pharmaceutical Companies in Italy proposed by AFI and PDA Italy Chapter and will introduce the innovative content and modalities of this Event.
EVENT VENUE
Palazzo degli Affari
Piazza Adua, 1 – Florence
For further information, please contact the Organizing Secretariat:
New Aurameeting Srl
Via Rocca d’Anfo, 7 – 20161 Milano
Tel. 0039 02 6620 3390
eventi@newaurameeting.it – www.newaurameeting.it