AFI STUDY DAY – UNDERSTANDING, PLANNING AND INTERPRETING THE VALIDATION OF AN ANALYTICAL METHOD
ICH Q2 guidelines have been a stable reference for validation of the pharmaceutical analytical methods for twenty years, but in the last 5 years articles from USP and FDA, EMA and ANVISA guidelines introduced new requests and new points of view, not always in total agreement; lastly, one year ago ICH announced the revision of its guidelines and the drafting of a new Q14 document on the analytical development. The certainty that analytical methods are suitable for the purpose is not only a request from the supervising authority, but above all an essential requirement concerning the quality of development and production. We want to discuss about the experience and the interpretations acquired in recent years, with the aim to renew knowledge and practice in our company and to prepare ourselves for understanding regulatory development in the coming years. The study day won’t be a statistic course and presentations will have a practical character, but speakers will mention tests and methods used and a mathematician will help us understanding the meaning of a statistic test and avoiding the most common errors in its interpretation.
The study day is a part of AFI commitment to follow the development of ICH Q2(R2), Analytical validation and Q14, Analytical procedure development carefully
Piazza Luigi di Savoia, 6 – Milano
Metropolitana M2 e M3 – Fermata Centrale
• Euro 250,00 + VAT 22% for AFI Associates
• Euro 370,00 + IVA 22% for AFI non Associates
Participation Fee includes:
• 2 coffee breaks
• 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 october, 9
Participation Fee can be paid by:
• Bank Transfer to: NEW AURAMEETING Srl
Banco BPM: Filiale 00617
• 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.