06/11/2018
2018 PDA Italy Chapter Congress and Exhibition presents:
TECHNOLOGY TRANSFER IN BIOPHARMA PROCESSES AND OPERATIONS - Milan, November 6th, 2018
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
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AGENDA 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 |
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GENERAL INFORMATION
Novotel Milano Nord Ca’ Granda Registration are open, click here to register Deadline Registration: October 20th ! For registration, general information and payment enquiry, please contact: pda@pda-it.org
Early bird discount: 15% of discount for confirmation received within September 30th, 2018
Exhibition and Sponsorship Opportunities are welcome. A basic exhibition package for this event is priced 1.000 € net
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Allegati :
- PDA Italy Chapter presents.pdf (1)
- PDA IT programma Tech Transfer 6 Nov 2018 MI_2.pdf
