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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Italy Chapter Technology Transfer in Biopharma Processes and Operations Event

Nov 06 - Nov 06, 2018 |
Nov 06, 2018 |
| Milan, Italy
  • Chapter
  • Europe
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Milan, November 6th, 2018

PDA Italy chapter is proposing a full day congress on Technology Transfer. During the event you will have the opportunity to listen real case studies showing how companies are dealing with all the problematics linked to a drug transfer and discuss with experts.

You will have the opportunity to share your experience and scientific knowledge and to network with peers to gain insights into latest industry trends and innovations in pharmaceutical manufacturing.

The event is of interest for all those professionals who are involved in drug technology transfer processes, and all the ones who would like to increase their knowledge on this topic.

DOWNLOAD the program for agenda and additional information.

 

In the last years Italian pharma companies have been heavily involved in transferring new drugs manufacturing in and out of their facilities. The increase of CDMOs and CMOs business and strategic changes in the pharmaceutical world like mergers and acquisitions increase the necessity to transfer production from one site to another making technology transfer one of the hottest topics of pharmaceutical production!

It is hard to evaluate how many drug manufacturing transfers are taking place every year, however considering the data we have been able to gather we evaluated that the number of transfers managed every year by Italian pharma manufacturers has increased by more than ten times in the last 10 years. A series of challenges are linked to technology transfers like:

  • establish a productive relationship with the donor site, respecting their timeline and mitigating their requests
  • discuss and coordinate all suppliers involved;
  • use the current production capabilities to develop new processes and manufacture validation lots without affecting the site commercial capacity;
  • evaluate risks in case process changes are required;
  • assure no contamination and robust cleaning procedures with respect to commercial products manufacturing.

08:30 – 09:00 Welcome and Registration
09:00 – 09:15 Opening remarks and proposed discussion topics  Angela Molaschi, NTC and PDA IT Chapter President
09:15 – 10:00 Risk based approach on Technology Transfer Mirko Gabriele, Patheon
10:00 – 10:45 Overview of Technology Transfer cases and related approaches Angela Molaschi, NTC
10:45 – 11:15 Coffee Break at the sponsors area
11:15 – 12:00 Technology Transfer of a biosimilar product-a case study of science based risk management approach Sergio Chiuderi, Eli Lilly Italia
12:00 – 12:30 Open Panel Discussion
12:30 – 13:45 Networking Lunch at the sponsor area
13:45 – 14:30 Technology Transfer of an ADC (Antibody Drug Conjugated) products: from conjugation to fill/finish Maria Elena Guadagno, BSP Pharmaceuticals
14:30 – 15:15 Technology Transfer Model in Alfa Sigma Andrea Piersigilli e Monia Ghirardini, Alfa Sigma
15:15 – 15:45 Coffee Break at the sponsors area
15:45 – 16:30 Case study,  Duccio Mattii, GSK
16:30 – 17:15 Case study, to be defined
17:15 – 17:45 Open Panel Discussion with Q & A and Final Consideration

Moderator: Mauro Giusti, Eli Lilly Italia

Planning Committee

Ceresa Lucia – Charles River
Gabriele Mirko – Patheon
Legnani Antonio – DOC
Molaschi Angela – NTC
Paganini Giuseppe – Merck
Peron Gabriele – Stevanato Group

Registration is open at our website www.pda-it.org

For registration, general information and payment enquiry, please contact: pda@pda-it.org  

150 € University and Regulators
450 € PDA member
550 €PDA NON member
700 € for 2 colleagues for the conference at the same time
850 € for 3 colleagues for the conference at the same time

Registration Deadline: September 10th, 2018

Early Bird Discount: 15% off discount for confirmation received before July 30th, 2018

Payment Information
Bank Transfer Beneficiary: PDA Italy Chapter
Address: Unicredit, Agenzia di Torino, Corso Vittorio Emanuele (TO) 
Mandatory causal: Technology Transfer + NAME and SURNAME of the participant/Company
BIC SWIFT: UNCRITM1AD3 IBAN: IT 16 J 02008 01133 000104537332

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. Copy of the bank transfer should be sent to our Secretariat at pda@pda-it.org  

 
The event will be held in Milan.  More information is coming soon.
Exhibition and Sponsorship inquiries are welcome.

A basic exhibition package (table-top + 2 individual passes for the conference) is priced 1.000 € net

Also available the following additional options: 

+ 150 € for a 3rd person at the table top (total 1150 €) 

+ 500 € including two invited attendees (total 1500 €) 
Register Now
http://registration.ccicongress.com/cmsweb/Login.asp?IDcommessa=C048/18&Lang=IT

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