PDA Italy Chapter: Annex 1 - One Year Later
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Registration Options
Individual Registration
Group Registration
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.
This event will take place at the Palazzo degli Affari Conference Center.
Official Language: Italian, with course material in English.
Agenda
Discover What's Happening Each Day
09:00am - 09:30am | Registration and Welcome Coffee at the Sponsor Area
09:30am - 10:15am | Welcome and Congress Introduction: Giorgio Bruno, Presidente, AFI and Mirko Gabriele, President, PDA Italy Chapter
10:15am - 10:30am | Summary of Survey Results: Francesco Boschi, AFI/Pfizer and Francesca Selmin, AFI/PDA Italy Chapter/UniMi
| Session 1: Regulatory Updates: Orazio Cultrera, AFI/PDA Italy Chapter/Cultrera Consulting and Alessandro Regola, AFI |
10:30am - 11:00am | Annex 1: How its Implementation Looks Like After One Year From its Enforcement: The Industry Point of View (tentative title): Gabriele Gori, PDA/EFPIA
11:00am - 11:30am | Annex 1 under FDA perspective (Tentative title) : Michael Shanks, FDA
11:30pm - 12:00pm | AIFA (Title to be received): AIFA TBC
12:00pm - 12:30pm | Q&A Panel Discussion
12:30pm - 1:00pm | Working groups - Session 1: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
1:00pm - 2:00pm | Networking Lunch
| Session 2: QRM & CCS: Giovanni Cosmi, AFI/PDA Italy Chapter/Cosmi Consulting and Michele Simone, PDA Italy Chapter/Bracco Suisse SA |
2:00pm - 2:20pm | Implementation of CCS strategy within Annex 1 Requirements: Barbara Ambruosi, Merck and І Sara de Pinto, Merck
2:20pm - 2:40pm | CCS Case Study: Di Morris, PNR Pharma (Waiting for confirmation)
2:40pm - 3:00pm | A Practical Example of QRM for a PUPSIT Case Study: Laura Venezia, GSK
3:00pm - 3:30pm | Q&A Panel Discussion
3:30pm - 4:00pm | Working groups - Session 2: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
4:00pm - 4:30pm | Coffee Break in Sponsor Area
| Session 3 : Barriers: Mauro Giusti, PDA Italy Chapter, Past President and Filippo Trionfera, PDA Italy Chapter President-Elect
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4:30pm - 5:00pm | Gloves Management in Barrier Systems Case Study: Patrizia Muscas, Eli Lilly and Company
5:00pm - 5:30pm | Indirect Contact Parts in Filling Operations: Sterilization Material Transfer and Set Up: Fabrizio Gelli, GSK Siena
5:30pm - 6:00pm | Q&A: Panel Discussion
6:00pm - 6:30pm | Working groups - Session 3: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
6:30pm - 6:45pm | Closing Remarks: Giorgio Bruno, Presidente AFI and Mirko Gabriele, PDA Italy Chapter President
7:30pm - 10:00pm | Networking Dinner
08:30am - 09:00am | Registration and Welcome Coffee at the Sponsor Area
09:00am - 09:10am | Welcome & Short Summary of Day1 event: Giorgio Bruno, Presidente, AFi and Mirko Gabriele, PDA Italy Chapter President
| Session 4: Utilities/Filtration F. Esposito and Lino Pontello, AFI
|
09:10am - 09:40am | Sterilizing filtration for Filled Syringes: Matteo Sala, IBSA
09:40am - 10:10am | Implementation of an In-place Sterilizable System for Peristaltic Pumps: Cristina Trovò, Haupt Pharma (Aenova Group)
10:10am - 10:40am | Q&A: Panel Discussion
10:40am - 11:10am | Working Groups - Session 4: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
11:10am - 11:40am | Coffee Break in the Sponsor Area
| Session 5: EM & APS: Francesco Boschi, AFI/Pfizer and - Lucia Ceresa, AFI/PDA Italy Chapter
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11:40am - 12:10pm | Environmental Monitoring Performance Qualification of New Facilities Case Study: Application of Industry Harmonized Approach: Anna Campanella, Takeda
12:10pm - 12:40pm | Holistic Approach for Aseptic Process Simulation Activities: Andrea Pranti, GSK
12:40pm - 1:10pm | Q&A: Panel Discussion
1:10pm - 1:40pm | Working Groups - Session 5: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
1:40pm - 2:40pm | Networking Lunch
| Session 6: Lyophilization Francesca Selmin, AFI/PDA Italy Chapter/UniMi Marco Adami, AFI and Claudia Bianchi Carnevale, AFI/Pfizer
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2:40pm - 3:00pm | A Qualified Method for Stopper Height Detection in Lyophilized and Liq Products: A Step Towards Annex1 CCI Compliance: Simon Mills, Ipsen Biopharm Limited
3:00pm - 3:20pm | Influence of Annex 1 Update on Lyo Operations: Bert Van Meervenne, Pfizer
3:20pm - 3:40pm | Case Study: Annex 1 Upgrade of Existing Lyophilization Plant: Enrico Capogna, Sanofi
3:40pm - 4:10pm | Q&A: Panel Discussion
4:10pm - 4:40pm | Working Groups - Session 6: The participants, divided into working groups, will discuss the updates and any doubts or clarifications still necessary.
4:40pm - 5:10pm | Congress' Closing Remarks: Giorgio Bruno, Presidente AFI and Mirko Gabriele, PDA Italy Chapter President
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
For hotel reservations, please send an e-mail to: NEW AURAMEETING 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 Hotel Grifone
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 The Social Hub
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 Hotel Firenze City Center
Registration
Pricing Options
| Registration Type | Fee |
|---|---|
| AFI and PDA members, for 1 day | € 480,00 + VAT |
| AFI and PDA members, for both days | € 730,00 + VAT |
| Non-members, for 1 day | € 580,00 + VAT |
| Non-members, for both days | € 830,00 + VAT |
* Fee includes coffee break, lunch and networking dinner.
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 upon online registration:
Payment of the registration fee must be strictly made before the beginning of the event. 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 AURA MEETING 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.
*NEW AURAMEETING can be contacted by phone +39 02 66203390 or by email: eventi@newaurameeting.it
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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