AFI – PDA Italy Chapter – ANNEX 1 – One Year Later

Data Evento: 18/09/2024 - 19/09/2024
Luogo Evento: Palazzo dei Congressi - Piazza Adua, 1 - Firenze
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L'evento

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.

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.
Speakers with proven competence and experience will illustrate the interpretation of the requirements and their planned or ongoing application, giving the working groups inspiration to develop questions and suggestions.

Official language: Italian, with course material in English

 

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AFI and PDA Italy Chapter propose a Survey on Annex 1 implementation, whose final results will serve as ideas for organizing discussion tables among all participants of the congress.

 

The event and the results of the Survey will be presented in a free webinar, scheduled for September 6, 2024, from 10:00 am to 11:00 am

GENERAL INFORMATION

EVENT VENUE
Palazzo degli Affari
Piazza Adua, 1 – Florence
(walking distance from Santa Maria Novella Station)      
https://www.firenzefiera.it/visita/palazzo-degli-affari

PLANE
Amerigo Vespucci International Airport (FLR) is only 4 km away from the center of Florence, and the Tram Line T2 connects it to Santa Maria Novella Central Station in 20 minutes.
Pisa’s Galileo Galilei International Airport (PSA) is an hour from Florence, and it’s connected to the city center by hourly trains and buses (Terravision company).

TRAIN
Thanks to the high-speed rail line, reaching Florence by train is a matter of minutes, and the fair district is within walking distance of the Santa Maria Novella central station.
From Bologna: 37 min; from Rome: 1 h 30 min; from Milan: 1 h 50 min; from Naples: 2 h 55 min.

TRAM
Line T1: VALFONDA stop – SMN STATION
Line T2: ALAMANNI stop – SMN STATION

PARTICIPATION FEE

  • Euro 480.00 + VAT for AFI and PDA members, for 1 day
  • Euro 730.00 + VAT for AFI and PDA members, for both days
  • Euro 580.00 + VAT for NON-members, for 1 day
  • Euro 830.00 + VAT for NON-members, for both days

The participation fee includes:

  • coffee break
  • lunch
  • networking dinner

For hotel reservations, please send an e-mail to: eventi@newaurameeting.it no later than July 30, 2024, specifying the choice of the hotel, dates and number of rooms required.
Subject to availability, New Aurameeting will send the hotel voucher with the method of payment.         
It is strongly recommended to make your reservation as early as possible, as September in Florence is very high season and it may be difficult to find hotel accommodations.

Hotel Grifone – 4-star (located in the historic center, 15 minutes by car from the conference venue and Santa Maria Novella Station)
Rate: € 185.00 VAT 10% included per night, in DUS room, breakfast included
https://www.hotelgrifonefirenze.it/

Hotel The Social Hub – 4-star (walking distance from the congress venue and SMN Station)
Rate: € 254.00 VAT 10% included per night, in DUS room, breakfast included
https://www.thesocialhub.co/it/firenze-lavagnini/

B&B Hotel Firenze City Center – 3-star (located historic center, 15 minutes by car from the congress venue and Santa Maria Novella Station)
Rate: € 145.00 VAT 10% included per night, in DUS room, breakfast included
https://www.hotel-bb.com/it/hotel/firenze-city-center

REGISTRATION AND PAYMENT METHODS
Registration must be made no later than September 6, 2024 to New Aurameeting; the participation fee can be paid by:

  • bank transfer to: NEW AURAMEETING Srl

Banco BPM:
Branch: 00617
IBAN: IT91J0503401726000000043206
BIC/SWIFT: BAPPIT21617 

  • Credit card during the online registration

 

Payment of the registration fee must be strictly made before the beginning of the study day. New Aurameeting will notify by e-mail confirmation of registration.

Registrations will be accepted subject to availability.

Cancellations received in writing within 7 days of the day will be 100% refunded; after this deadline, no refund will be given except for the possibility of replace the registrant with another name.

AFI, PDA Italy Chapter and NEW AURAMEETING reserve the right to suspend or postpone the study day if the minimum number of participants is not reached, in which case the registration fee if already paid will be refunded.

 

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

 

 

 

 

 

 

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