Chairmans report 2004
Dear BFS member,
Christmas holiday is drawing near as I reflect upon our activities in 2004. About this time, a year ago, we had submitted the BFS IOA comments to the FDA aseptic processing guidance. The preparations of these comments, constituted a major work in the history of the BFS Association, and involved both assistance from many of you, our members, as well as input from various academic partners.
At our first meeting for the year, arranged in connection to the PDA meeting in Orlando, Florida in March, we got yet another opportunity to interact with Rick Friedman of FDA. It was during our conference dinner, held at the conference hotel in Orlando, that I got the first indication from Rick that the FDA looked positively on harmonizing with EU requirements on aseptic BFS processing and that he found the interactions with our Association very stimulating.
Our next meeting for the year was held in my home town of Stockholm. In June, Stockholm is at its best, and we held our conference dinner at one of the small islands in the archipelago. Also this meeting included interactions with the FDA and the Swedish MCA and naturally some interesting topics from BFS users. The conference was ended by a company visit at the AstraZeneca BFS plant in Södertälje, south of Stockholm.
Our final meeting for this year, was held in India, at the beautiful coast of Goa. Already in 2003, we had participation from two inspectors from the India Health Authorities. Therefore, I was very happy that Mr. Venkateswarlu (Deputy Inspector General of India) felt it was worthwhile participating also in this years meeting, where we amongst other things discussed the India Schedule M, and its similarities and differences from European and US guidance.
In recent years, the BFS IOA has developed intense interactions with a multitude of authority bodies, and this year, we got the first real proof that this strategy can pay off. I truly believe that our discussions with FDA have influenced the final guidance text in a significant way. We are, no doubt, seen as the expert group when it comes to BFS processing, and as Eric will mention in his Technical Officer report, I hope that we some day can publish an official Technical report, to help users in their specific BFS interpretation of various guidance. After all, this is why we as an industry association still exist; we bring you value for money. With the low yearly fee we currently have and the dedicated work of my fellow board members and appointed Officers we hope you agree that 2004 provided that value.
Looking ahead, we are planning our program for the next AGM, to be held in Barcelona, Spain in March. Mark your calendars for this event and keep an eye on our homepage for the agenda and registration details.
Finally, I am looking forward to see you all at our meetings in 2005.
Anders Löfgren, Ph.D.,
Chairman of the Board, The Pharmaceutical BFS International Operators Association
c/o AstraZeneca R&D, Södertälje, Sweden