Chairman Piero Iamartino MICRO-MACINAZIONE S.A. (CH) 8.30 Registration of Participants 9.00 Welcome: About ISPE Sonia Ricci – President of ISPE Italy Affiliate 9.15 Presentation of ISPE DACH Containment Manual Richard Denk – HECHT TECHNOLOGIES GmbH (Germany) 9.45 The toxicological basis of containment Andreas Flueckiger – F. HOFFMANN-LA ROCHE AG, Basel (CH) Forum Day Containment in the Manufacture of Highly Potent APIs and Dosage Forms Date: Wednesday 25 June 2014 Location: SALA SOLARI – CENTRO CONGRESSUALE PALAZZO delle STELLINE Corso Magenta 61 - Milano Scope of the forum Addressing the challenges for the manufacture of HPAPIs and their relative dosage forms, focusing on the criteria of containment systems design, qualification and reporting practical experience based on case histories. Forum in collaboration with ISPE DACH Affiliate 10.15 Design selection criteria of containment systems Germana Molinari – FWI, Milan (Italy) 10.45 Coffee Break 11.15 Refitting of an API plant with flexible containment Friederike Hermann – LONZA AG, Visp (CH) 11.45 Containment upgrade of building 80 Martin Pernau – BAYER HEALTH CARE, Leverkusen (Germany) 12.15 The HAPIs containment in R&D: from project to validation Roberto Bugarin – CHIESI, Parma (Italy) Emilio Moia – JACOBS ITALIA (Italy) 12.45 Discussion 13.00 Buffet Lunch 14.30 Risk analysis in designing a containment system Leonello Sabatini – ASSCA (Italy) 15.00 Flexibility and scalability of containment systems for a capsules filling process Marco Bellentani – MG2 (Italy) 15.30 Coffee Break 16.00 Containment in development and industrial manufacture of anticancer dosage forms Fabio Zenobi BSP Pharmaceuticals, Latina (Italy) 16.30 Containment line for physical treatment of a sterile HPAPI powder Enrico Bettetini SICOR-TEVA, Santhia (Italy) 17.00 Discussion 17.30 End of the Forum Attendance Conditions Attendance Instructions Application Form The Forum Day will be reserved for the members of ISPE Italy Affiliate. Conditions of participation: - send the application form to ISPE: [email protected] Phone: +39 02 4486.6712 Last Name Non members from CEE area may obtain ISPE annual membership (fee is €219) for full participation at the Forum Day. If you have any further questions or need assistance, please contact: ISPE: [email protected] Participation Fees: ISPE Members NOT ISPE Members ISPE Members from other Affiliates € 250 € 470 € 250 Students and Academics Free Discounts: A discount of 20% will be applied for any additional delegates of the same Company. once you receive the pro-forma receipt from ISPE, proceed with payment of the participation fee to the following account: Recipient Name: ISPE Affiliata Italiana Bank Name: IW BANK CIN: N ABI: 03165 CAB: 01600 N° conto: 110497555 IBAN: IT72N0316501600000110497555 Purpose of payment: Event participation cancellations may be made in written form before 5 days without check-off payment; after, full payment must be made. The substitution of the participant is allowed with another person designated. First Name Company Role ISPE Membership Number Participation Fee Euro Address Tel Fax e-mail Ai sensi del D.Lgs. 196/2003 autorizzo ISPE a trattare i dati sopra riportati per la realizzazione di tutte le proprie attività istituzionali, ivi compresa la comunicazione, l’informazione e la promozione. Date Signature
© Copyright 2025 ExpyDoc