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Manufacturing trend of parenterals: a glance to the future

  05/10/2017 - 06/10/2017


 

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

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

 

PDA Italy Chapter, announces the next congress on future of parenterals that will be held at “Hotel dei Principi” in Bari on 5th and 6th of October 2017.

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.

During the second day, there will be the opportunity to visit Merck manufacturing site, based in Modugno close to Bari, with a specific tour of the new of the new isolator technology and of the fully automated warehouse. 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.

MARK YOUR CALENDAR!

Here below some 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

 

You are welcome to actively join at this exciting event sending an abstract for a presentation or a poster of subscribing the pre-registration in order to have an additional discount (early bird price till 31th July 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!

Here below the list of the speakers that will be present:

  • Annant Janmeet, Ph.D., Board Member of the BioProcess Systems Alliance (BPSA)
  • Casillo Maria Grazia, Resp Area Sterile 5, Patheon Monza
  • Calvano Annalisa, Manufacturing Operations Director, Merck Bari
  • D’Amato Andrea,  Sr Site Director, Merck Bari
  • Ferrazin Fernanda, Ex GMP AIFA Senior Inspector, Independent Pharmaceutical Consultant
  • Gabriele Mirko, Production Director, Patheon Ferentino
  • Giani Chiara, Site Manufacturing Strategy Leader, GSK Vaccines
  • 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
  • Toumi AbdelazizHead of Biotech Strategy , Merck

 

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

 

 

For PDA Member and NON PDA Member registration click here

 

TO HAVE A LOOK TO THE SPEAKERS' ABSTRACTS CLICK HERE

 

 

Exhibitors

 

 


Allegati :


- PDA_bari.pdf



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