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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Italy Chapter Presents - Manufacturing Trends in Parenterals, A Glance to the Future

Oct 05 - Oct 06, 2017 |
Oct 06, 2017 |
Hotel Parco dei Principi | Bari,
  • Chapter
  • Europe
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PDA Italy Chapter, announces its next congress on the future of parenterals, to be held at the Hotel dei Principi in Bari on 5th and 6th of October 2017.

We will be glad to have you with us in these two days of professional growth, discussion and update on the main trend of parenteral production and its future!

Agenda

A detailed agenda can be viewed here.

Day 1, Thursday Oct., 5th: Hotel Parco dei Principi

On the first day, a series of case studies related to different technologies will be presented with the aim of sharing and discussing the main production and regulatory challenges and the way they have been overcome.

Day 2, Friday, Oct., 6th: visit at Merck HC manufacturing capabilities

During the second day, there will be the opportunity to visit the Merck manufacturing site in Modugno, close to Bari, with a specific tour of the new isolator technology and of the fully automated warehouse. The Merck Modugno site is a "Fill & Finish" manufacturing site and it delivers products in more than 150 countries worldwide. The site is specialized in aseptic filling and packaging of biotech drugs in both freeze-dried and liquid form. It is established on an area of 125,000 square meters where 25,000 are occupied by the Plant consisting of several buildings: the production building, the laboratories, the warehouse, the services and utilities buildings, and the glass structure where the administrative offices of the Plant Management are located. The Site has received and successfully passed a large number (more than 30) of inspections by the Health Authorities of the major countries in the world including EMA (European Medicines Agency), U.S.FDA and CFDA China.

Topics

Below are the main topics that will be presented and discussed:

  • Mega trends in BioPharm
  • Quality System and Quality evaluation/approach on different type of technologies
  • Barrier and Isolators: introduction, use and qualification
  • Single Use: introduction, use and qualification
  • Annex 11

Submit an Abstract

You are welcome to actively join at this exciting event by sending an abstract for a presentation or a poster.

To submit your abstract click here

Speakers

Below are the speakers that will be present:

  • Cassani Flavio, Production Director, Patheon
  • Calvano Annalisa, Manufacturing Operations Director, Merck Bari
  • D’Amato Andrea,  Sr Site Director, Merck Bari
  • Giusti Mauro, Director Technical Services/Mfg Science and Mfg Sourcing/Vendor Mngt, Eli Lilly Italia
  • Mannini Massimo, New Product & Platform Introduction Head, GSK Vaccines
  • Matarrese Elisabetta, Compliance Manager, Merck Bari
  • Molaschi Angela, Strategy and Technology Transfer Project Manager, Actavis Italy/Teva Company and PDA Italy Chapter President
  • Simone Michele, Director of Corporate Quality Management, Bracco Suisse S.A

Registration

Conference fee
- 300 € PDA member
- 380 € PDA NON member
- 500 € for 2 colleagues for the conference at the same time - Please contact the organizing secretariat for registration
- 750 € for 3 colleagues for the conference at the same time -  Please contact the organizing secretariat for registration

Early bird discount: 15% of discount for confirmation received within July 31th, 2017!

For PDA Member and NON PDA Member registration click here

Payment information:
Bank Transfer Beneficiary: PDA Italy Chapter, Loc. Salceto, 91- 53036 Poggibonsi (SI)
Address: Unicredit, Agenzia di Torino, Corso Vittorio Emanuele (TO)
Mandatory causal: Manufacturing trend of parenteral: + NAME and SURNAME of the participant
IBAN: IT 16 J 02008 01133 000104537332, BIC SWIFT: UNCRITM1AD3

Payment must be received or guaranteed by Purchase Order or copy of transfer details on the day before the event at the very latest and should be sent to: pda@pda-it.org

Please, note that the registration fees for institutional activities are VAT free (art. 4, 5° comma DPR 633/72), therefore we will send you a RECEIPT and not an invoice.

Exhibition/Sponsorship Inquiries

Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.000 € net (table-top + 2 peoples pass for the conference) + 200 € for a 3rd peoples at the table top. For more information please contact: pda@pda-it.org

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