The  Parenteral Drug Association Cold Chain Management Conference 2007 concluded last week in Bethesda, Maryland. It was PDA's second US cold chain conference, and it was twice what it was 15 months ago when they hosted their inaugural event. In March 2006, the PDA attracted about 110 delegates and 8-9 supplier display booths. This year's conference had more than 210 delegates and 16 supplier displays. Approximately 2/3 of the attendees were directly involved in manufacturing and distribution of medicinal cold chain products and 1/3 in supporting services. The quality, and relevance of the regulatory and technical information presented at this year’s conference was outstanding.

 

 

In 15 months time the PDA has elevated the genre to an entirely new level - making all other cold-chain conferences seemingly irrelevant and obsolete. There is one overwhelming reason for this: unlike commercial conferences, the PDA Cold Chain Management Conference is given for industry by industry.

 

There are significant advantages to doing this -

 

  • delegate cost: admission to the PDA conference costs about 50% less than most other conferences
  • display cost: a tabletop booth at PDA costs 70% less than IQPC,  for example, drawing more companies
  • credibility: The Pharmaceutical Cold-Chain Interest Group (PCCIG) who organized the event operates under the auspices, and full support of, the Parenteral Drug Association (PDA), a non-profit, international organization that bridges science and regulation. The PDA is without question, the leading global provider of pharmaceutical and bio-tech science, technology and regulatory information. Additionally, they have a well-established and well-respected educational arm that is focused solely on the pharmaceutical and bio-tech community. They have extremely high standards and are committed to advancing science and regulation through the expertise of its more than 10,000 members worldwide.
  • commercial free zone: Even though some of the presenters were from the supplier side of the industry, there were no commercial presentations and the information they provided was timely and pertinent. The PDA focuses on science-backed data and regulatory issues and is adamant about curbing thinly veiled sales pitches common at other conferences.
  • resources: At the first meeting held in 2000 at Genentech, I was one of the original 14 members. Today's PCCIG membership exceeds 400. The group's bio-pharmaceutical cold-chain guidance document Technical Report #39 (which this year has undergone a revision to include more global perspective) has received cGMP approval from the US Pharmacopoeia, FDA, MHRA (UK) and Health Canada as a leading guidance document for cold-chain distribution practices, and is a reference document among those regulatory authorities conducting audits for manufacturing and distribution practices.
  • standards: the PDA PCCIG is working on several other standards that will likely be accepted by the pharma industry; notably, a master validation plan, a protocol for collecting temperature data in distribution, vibration and barometric pressure profiles in transportation (in cooperation with the International Safe Transit Association) and an accredited continuing education program.
  • delegates:  Those in attendance are not novices or among the rank-and-file in cold chain. Rather, they are Principal Packaging Engineers, Directors, VP's, Fellows, Application Scientists, Professors, etc. In other words, the key decision makers within their respective organizations.
  • global reach: This is the first cold chain conference to attract international delegates. This year’s crop of attendees came from Japan, Canada, Ghana, Colombia, Germany, France, Switzerland and Israel.
  • logistics/organization: the facility, food and supporting services were superior in to most other cold-chain conference I have ever attended.
  • regulatory acceptance: This is the only cold chain conference to attract regulatory authorities who not only presented, but fielded questions from the delegates. The USP, FDA, MHRA and Health Canada all spoke and commented at this year’s conference.

For information regarding next year's PDA Cold Chain Management Conference, scheduled for February 27-28, 2008, or the European Conference in Berlin, Germany, October 17-18, 2007, contact the PDA at pda.org. In addition to the conference, the PDA will be offering a two day training on cold-chain.