AFI STUDY DAY FOR QUALIFIED PEOPLE WHO CERTIFY INVESTIGATIONAL MEDICINAL PRODUCTS

Date: 19/09/2019
Venue: Hotel Michelangelo - Milano
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Event

Legislation on production of medicines for experimental use (Investigational Medicinal Products, IMPs) requires that every batch of medicines must be certified for clinical use by a Qualified Person, analugously to the certification of the batch for sales of commercial medicines. IMPs, as products under development, subject to continuous change to optimize their production, have the characteristic of being drawn up specifically for a clinical study, so needing a secondary packaging (sometimes a primary packaging) specific for the clinical study, which can be open label or blinded. It is therefore necessary that the QP in charge of the batch certification have appropriate skills and competence, as requested by Annex 13 to EU GMP (Manufacture of IMPs). This study day aims to offer the QP and all those who are involved in the setup and management of IMPs to acquire a better and more complete vision of this products’ characteristic, in order to fully understand the different operational aspects between GMP e GCP and become involved in the achieving of a quality product, for the prioritary safeguard of patients and, consequently, of scientifically valid data, resulting from clinical studies. Furthermore, in order to make the training more effective, participants will be asked to point out, by a survey, what aspects are the most critical among those who a QP must face daily.

GENERAL INFORMATION

Sede della Giornata
Hotel Michelangelo
Piazza Luigi di Savoia, 6 – Milano
Metropolitana M2 e M3 – Fermata Centrale

Participation Fee
• Euro 250,00 + VAT 22% for AFI Associates
• Euro 370,00 + IVA 22% for AFI non Associates

Participation Fee includes:
• 1 coffee break
• 1 lunch

Participation Fee for non Associates includes free AFI one year Membership. AFI Secretariat will contact non associates to finalise the accession.

Methods of Payment
Registration must be finalised by september, 12
Participation Fee can be paid by:

• Bank Transfer to: NEW AURAMEETING Srl
Banco BPM: Filiale 00617
IBAN: IT91J0503401726000000043206
BIC/SWIFT: BAPPIT21617

• Credit Card during the online registration

In case of bank transfer, the payment must compulsorily be made before the study day. New Aurameeting will confirm registration by mail. Registration will be accepted until seats are available.

Cancellations received up to 7 days before the study day in writing will be 100% refunded. After this deadline, no refunds will be provided, with the exception of the possibility to replace the registered with another person. AFI and NEW AURAMEETING reserves the right to cancel or postpone the study day in case of failure to reach the minimum number of participants: in this case, Participation Fee, if already paid, will be fully refunded.

For further info, please contact the Organizing Sceretariat:
New Aurameeting Srl
Via Rocca d’Anfo, 7 – 20161 Milano
Tel. 0039 02 6620 3390
eventi@newaurameeting.it – www.newaurameeting.it

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