It concluded much more favorably than anyone involved had anticipated. From the organizers to the attendees, everyone I spoke with agreed that the event exceeded their estimates and expectations. Registrants got their money's worth, the PDA gained new members and the PCCDG increased its momentum and credibility among the industry and the world's leading pharmaceutical regulatory agencies. Even the jaded and hard-to-please came away from this week's conference satisfied.
The relevancy and quality of content from the presenters surprised many. Much of that credit has to go to Bob Dana, Vice President Quality and Regulatory Affairs, PDA; and the highly respected PDA-PCCDG chair, Rafik Bishara, who used their significant influence, dash and charm to coerce even the most stubborn leaders within the pharmaceutical cold-chain industry to "volunteer," moderate or present at this inaugural conference. This was most evident by convincing the elusive FDA to attend and present. (See March 27th posting: Regulators Comment on Technical Report No.39, Shipping Outside of Label Claim and Monitoring).
In addition to the recap of events outlined in that posting, the highlights of the two day event were:
The chairs of the European Cold Chain Committee (C3) and the Pharmaceutical Logistics Forum (PLF) attended and agreed to begin a dialog with the PCCDG on unifying efforts.
The endless stream of presenters referencing TR 39, the need for current good distribution practices (cGDP), quality agreements, procedures, training, and above all, good science.
The importance of including distribution temperature cycling studies as part of the overall product stability study programs.
The importance and advantage of including such studies in PLA filings.
The hope of the PDA was to have 75-80 in attendance. A total of 116 people registered. 10 exhibitors, all directly involved in cold-chain, helped sponsor the event. The PDA staff were extremely well organized and efficient. The hotel, if not a little inconvenient to the area's 3 airports, was elegant, the food a few notches above most and the venue was dramatic and spacious. The IT/AV crew never left the room and not a single technical mishap occurred.
The goal, of course, was to educate, inform, increase awareness of and involvement in, cold-chain. In my opinion, it was a home run!
If any of you who were in attendance have comments to make about the conference, or ideas and suggestions for improving the next meeting, why don't you share them with us? I'm sure the PDA and the organizing committee would appreciate the feed-back too.
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I suspect the next PDA-PCCDG conference will outdistance this one. There is talk of a European meeting and making the Bethesda summit an annual event. My, how far we have all come in cold-chain in a few short years!
