Operation Officer's report at AGM 2002

Dear BFS colleague,

Initially I would like to thank all of you for attending the AGM in New Orleansand an outstanding co-operation during the years.

2002 has been an extremely busy year for the BFS Association with meeting in Stuttgart in the early spring followed by a planned AGM in Dubai, which we unfortunately were forced to cancel due to the ongoing conflict in the Middle East region. The AGM was then transferred to New Orleans, venue Marriott Hotel, December 8-9, 2002.

Together with these activities, the BFS IOA has successfully co-operation with PDA based on the following contents:

  1. BFS will assist PDA in all subjects related to the BFS technology
  2. PDA will assist BFS in contact with FDA
  3. BFS will host PDA training seminar, where BFS members can attend at a reduced price
  4. PDA will need BFS in Asiaand Europe- BFS will need PDA in North America
  5. BFS will stay independent and will not be part of the PDA

Based on above 5 points, the co-operation has been established with positive results for the BFS Association already from the beginning. I refer to Anders Löfgren’s technical report, informing about PDA’s invitation to BFS to present our point of view in relation to FDA’s Concept Paper, Annex II.

PDA has requested the BFS IOA to organize a training seminar, to take place April 24-25, 2003, hosted by Cardinal Healthcare in the US. You will find registration on PDA’s website and we will revert to you soonest possible with all details.

Please also note that it is the intention of the BFS IOA to have special focus on the various points discussed by FDA’s Concept Paper.

Furthermore, PDA has asked the BFS IOA to participate in a PDA conference in the Czech Republic (Prague) as well as in Dubai. When the program is established for said meetings, it will be presented by PDA and BFS IOA.

BFS AGM 2003 will be arranged in Manchester, hosted by IVAX Pharmaceuticals, we are working with preliminary dates either during week 23 or week 25. We await final confirmation from hotels.

End of September/beginning of October, an Asian Chamber meeting will take place, venue is New Delhi region and agenda partly as the PDA training seminar, extended with special presentations covering FDA’s draft Concept Paper. Time and agenda will be published soonest possible.

The BFS Association has developed during 2002 and we have increased the organization with 5 new member companies in the Asian Chamber. Unfortunately we have lost 2 member companies in the European Chamber, however we have an increase in the Western Chamber with 4 companies. This leads to a total number of 101 members companies world wide, 22 companies in Asia, 47 companies in Europe and 32 companies in the Western Chamber. Especially, it was a great pleasure to welcome 2 new companies, which signed up for membership during the New Orleans meeting.

Once again thank you for an excellent co-operation during 2002 and with the best wishes for a successful and prosperous New Year to you, your families and your company.

Svend-Axel Laursen
Officer of Operation, Global Board
December 2002