Where cooler heads prevail

This elegant quote, attributed to the American Pulitzer Prize winning author, Willa Sibert Cather, is the theme for the 2010 Pharmaceutical Cold Chain Management Course on Wheels, the 7 day, 551 km, full immersion pharmaceutical supply chain experience, sponsored by the World Health Organization and the Parenteral Drug Association.

2010 marks the third consecutive year the highly regarded training course (2010 IQPC Cool Chain Europe Excellence Award Winner for Best Temperature Control Logistics Project) will meander its way through the mountains, valleys and along the seacoasts of western Turkey - from Istambul to Urla. The course is limited to 15 participants and runs from June 7-12, 2010.

The WHO Mentoring Series course (and the brainchild of the course, Director Dr. Umit Kartoglu), is unique in its presentation. There are no classrooms. All participation and discussion takes place on a tour coach, at rest stops and in cafes, usually in semi-open areas.

I once took part in a similar educational program in college - a 21 day geology field study course through the American Southwest. It was the greatest, most comprehensive and most enjoyable learning experience I have ever had. Thirty-five years later and I can still name all the layers of the Grand Canyon in succession - from Kiabab Limestone to Vishnu Schist - because I walked it; 14.5 miles from the North Rim to Phantom Ranch at the bottom and back out again. (More on this in the blog archives under The Cold Chain Chronicles: Worst Case Scenarios - An Allegorical Tale, 23 Feb 06).

Similarly in 2005, my wife, Colleen, and I drove the entire length of Historic Route 66 - roughly 2,450 miles from Chicago to Santa Monica.

We studied and read aloud to each other from various history books, guidebooks and maps during our 11 day sojourn as we traveled each segment of the highway through 8 states. Living it and driving every mile of it had a profound impact on my understanding and appreciation for 20th Century Americana history and it remains in my memory as unique, and the most interesting vacation that I have ever taken.

I imagine the Pharmaceutical Cold Chain Management Course on Wheels will be a lot like that. There is no greater learning experience than by immersing ones self in participation. The WHO and PDA’s purpose in sponsoring the course is to provide key players of the pharmaceutical cold chain with insights into complete cold chain operation and oversight from product manufacture (or arrival in a country) to its administration to the patient. This is done by bringing together a group of participants from the national regulatory authorities and pharmaceutical, biopharmaceutical, vaccine industry involved in the supply, packaging, distribution, logistics and cold chain management areas as well as industry members of immunization related equipment and device manufacturers.

I have the honor of participating as one of the course mentors for the 2010 course. An application and syllibus of the course are attached below. Some past participants, both mentors and students alike, have told me this course was an experience of a lifetime. I can't wait to find out!

The deadline for application and Cirriculum Vitae submissions for the 2010 Pharmaceutical Cold Chain Management Course on Wheels, June 7-12, 2010, Turkey is March 31, 2010

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Monday, February 1

WHO Posts Open Comment Period on draft Cold Chain Management Document

by Kevin O'Donnell on Mon 01 Feb 2010 04:08 PM CST

Dr. Umit Kartoglu of the World Health Organization (WHO), presented the draft of the long awaited Harmonized Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products at the IQPC Cool Chain Europe 2010 Conference in Amsterdam, Netherlands last week.

The 41 page document consolidates regulations and guidance on the storage and distribution of temperature-sensitive pharmaceutical products from a wide range of international sources into a single, relatively short document. The guidance has been prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management whose members have been central to the review process.

The harmonized document is intended to gain general acceptance as an international guide to good practice in this field, whilst accepting that local legislation and regulations will continue to take precedence. The document is specifically intended to have wide-ranging applicability in developing countries as well as in the industrialized world. The target audience are regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies. Once the document has been completed, fully reviewed and approved, it will be supplemented by relevant practical guidance material showing how the requirements set out in the guideline can be achieved in practice. This guidance material will take specific account of resource and other constraints in the developing world but will also describe best practice in the industrialized world.

A pdf. of the entire draft document is attached for those interested in reviewing and commenting.

The comment period continues until March 15, 2010.

All comments should be directed to Dr. Kartoglu at kartogluu@who.int.

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Advanced Degrees: Regulatory Changes and Guidance on Temperature Controlled Distribution 2010

by Kevin O'Donnell on Mon 01 Feb 2010 03:30 PM CST

Anyone involved in the manufacture and distribution of time- and temperature-sensitive drugs over the past decade has seen a significant evolution to the process. Manufacturing has gone global, distribution has become more diversified and there has been a surge in the manufacture of new biologic drugs. Guidance and regulations have barely been able to keep up with the growing demand and popularity of these therapies. There has been an increased awareness by industry and additional scrutiny given by federal regulators (FDA and other global regulatory bodies) for more transparency and documentation to support medicinal products in distribution. This includes a seismic shift in attention given to drugs at controlled room temperature (CRT) conditions. Temperature assurance has extending well beyond the traditional boundaries of “cold-chain” —

Read the entire article here.

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