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Technology Transfer in Biopharma Processes and Operations


2018 PDA Italy Chapter Congress and Exhibition presents:



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

For all these reasons PDA It 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.


One day congress plus panel discussion with International Speakers and Exhibitor on the following topics:

  • Risk management and risk-based GMP
  • Technology Transfer
  • Quality management systems for pharmaceuticals
  • Industry case studies - compliance and quality issues



08:30 – 09:00     Welcome and Registration

09:00 – 09:15     Opening remarks and proposed discussion topic, 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, Eleonora Spanò, IBSA

17:15 – 17:45       Open Panel Discussion with Q & A and Final Consideration


Moderator: Mauro  Giusti, Eli Lilly Italia




Novotel Milano Nord Ca’ Granda
Viale Suzzani 13, 20162 Milano


Registration are open, click here to register

Deadline Registration: October 20th !

For registration, general information and payment enquiry, please contact:

Conference fee

  • 150 € University and Regulatory
  • 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

Early bird discount: 15% of discount for confirmation received within September 30th, 2018

Exhibition/Sponsorship Opportunities

Exhibition and Sponsorship Opportunities are welcome. A basic exhibition package for this event is priced 1.000 € net
(table-top + 2 people pass for the conference). Also available the following additional options:

  • + 150 € for a 3rd peoples at the table top (total 1150 €)
  • + 500 € including two invited attendees (total 1500 €)


Allegati :

- PDA Italy Chapter presents.pdf (1)
- PDA IT programma Tech Transfer 6 Nov 2018 MI_2.pdf

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