Dedicated To Improving Pharmaceutical Cold-Chain Distribution Practices
View Article  The Cold-Chain Chronicles: On the road with the WHO

No, not the rock band The Who but the World Health Organization (WHO).

Next week I leave for Istanbul, Turkey to participate in the WHO-PDA Pharmaceutical Cold Chain Management on Wheels Course. I have had the good fortune to be selected as a mentor on this years bus sojourn which will leave from Istanbul, meander through 555km of the beautiful and ancient Turkish countryside to Bursa, Balikesir, Foca, and Gumuldur, and terminate in Izmir on the Aegean coast.

The 2010 award-winning course (see March 08, 2010 post Advanced Degrees: Recognizing Pharmaceutical Cold Chain Excellence) provides key players within the pharmaceutical cold chain  insights into complete cold chain operation and oversight from product manufacture (or arrival in a country) to its administration to the patient.

Each year the course unites a group of 15 selected participants from various national regulatory authorities and the pharmaceutical, biopharmaceutical, vaccine industry who are involved in the supply, packaging, distribution, logistics and cold chain management, as well as industry members of immunization related equipment and device manufacturers. The "on wheels course" provides for an immersive experience encouraging participants to make direct observations at the storage, warehousing, distribution and health care facilities that they visit as they physically travel with mentors by bus down the length of the cold chain. This approach is designed to show participants how the theoretical background of pharmaceutical cold chain management is applied in a variety of storage and health care facilities - a practical application of experiential learning theory.

Before we begin however, we'll need a few days of course preparation.

As time and technology permit, I intend to post to the Coolerheads Blog during our travels, report on our learnings and observations and share with you highlights of this unique educational experience and on the extraordinary Turkish culture and history that we find along the way.

I hope you will check back to follow our adventures - stay tuned...

Perge, Turkey, March 2010

View Article  Where in the World?...

The following is a running list (newest to oldest) of  conferences, meetings, round tables, webinars, trade shows, and related cold-chain events where I will be making a presentation or participating. Links provided.

I hope to see you there!

June 7-12, 2010

WHO / PDA Mentoring Series

Pharmaceutical Cold Chain Management on Wheels

Istanbul to Izmir, Turkey

"The end is nothing, the road is all"

Mentor

_________________

 

May 20-21, 2010

Midwest Healthcare Supply Chain Conference

Indianapolis Convention Center, Indianapolis, Indiana

Presentation:Complying with IATA Chapter 17 Revised Regulations and Biopharmaceutical Requirements for Temperature Sensitive Products 

_________________

May 2,3 & 4, 2010

Cargo Network Services Partnership Conference

The Doral Resort & Spa, Miami, Florida

Moderator: Time & Temperature Logistics for Healthcare Products

___________________

 

April 20-22, 2010

International Air Transport Association (IATA)

Live Animals & Perishables Board (LAPB) Meeting

Continental Airlines, Houston, TX

Time and Temperature Task Force Semi-Annual Meeting

______________________

April 12-13, 2010

2010 PDA Pharmaceutical Cold Chain Management Conference

Hyatt Regency, Bethesda, Md

Conference brochure: http://www.pda.org/swf/cold-chain-cat/index.html

___________________

March 8-11, 2010

IATA World Cargo Symposium

Sheraton Vancouver Wall Center, Vancouver, Canada

Plenary Chairperson Time & Temperature Track Feb 9-10

Conference brochure: http://www.iata.org/NR/rdonlyres/6405EF85-D7C6-455B-B72D-BF31AF1D50E6/0/TimeandTemperature.pdf

_______________________

 

February 23-25, 2010

8th Cold Chain Management & Temperature Control Summit

Westin Harbour Castle, Toronto, ON, Canada

Plenary Chairperson (Jan. 28th) &

 Panel Discussion: Complying with IATA Chapter 17 Revised Regulations & Biopharma Requirements for Temperature Sensitive Products

Conference brochure: http://image.exct.net/lib/ff2b12797165/d/1/Cold%20Chain%20Canada%202010.pdf

_______________________

January 26-28, 2010

9th Annual IQPC Cool Chain Europe 

Okura Hotel, Amsterdam, Netherlands

Plenary Chairperson (Jan. 28th)

 Presentation: Update on the Application of Revised Chapter 17 IATA Guidelines

____________________

December 8-9, 2009

IQPC Clinical Trials Logistics Conference

Ritz-Carlton Hotel, Philadelphia, PA

____________________

December 3-4, 2009

World Health Organization

Consultative Meeting With Industry

WHO Headquarters, Geneva, Swizerland

Co-Chair: Performance, Quality and Safety Meeting

_________________________

October 28-29, 2009

Panalpina Logistics Conference

Huntsville, Alabama

___________________________

October 20-21, 2009

International Air Transport Association (IATA)

Live Animals & Perishables Board (LAPB) Meeting

IATA Headquarters, Montreal, Ontario, Canada

Time and Temperature Task Force Semi-Annual Meeting

_____________________

October 6-7, 2009

2009 PDA Conference on Cold Chain Management:

From Suppliers to Customers

Berlin Hilton Hotel,

Berlin, Germany

Presentation: (Oct. 6th), Changes in the Air: The Impact of the New IATA Regulations on the Distribution of Time- and Temperature Healthcare Products

_________________________________

October 2nd, 2009

PARCS (Pacific Region Clinical Supplies) Fall Conference

Embassy Suites Hotel,

South San Francisco, California

Moderator:  Current Aspects of Shipping, Security, Storage, and Monitoring of Temperature Sensitive Investigational Drug Products

 _______________________

September 22-24, 2009

USP Annual Scientific Meeting 2009 - North America

Sheraton Centre Toronto Hotel,

Toronto, Ontario, Canada

Presentation: (Sept. 24th), Air Transport Logistics for Time & Tempeature-Sensitive Healthcare Products: Meeting the Requirements of the New International air Tranport Association Regulations

 _______________________

September 21st - 24th, 2009

IQPC 7th Annual Global Forum Cold Chain Distribution for Pharmaceuticals

Philadelphia Convention Center

Plenary Chaiperson for Transportation and Logistics Section (Sept. 23rd)

____________________

June 2-3-4, 2009

9th DHL Global Forwarding Life Sciences and Healthcare Global Conference

InterContinental Miami Hotel

_________________

May 13, 2009

Midwest Healthcare Supply Chain Conference

University Place Conference Center, Indianapolis, Indiana

Presented by the Indiana Health Industry Forum & The Indianapolis Airport Authority

Global Trade & Logistics Panel Discussion

_______________

April 24, 2009

Pacific Region Clinical Supplies (PARCS) Spring Meeting

Westgate Hotel, San Diego, CA

Presentation: "Regulatory & Best Practices Impacting Temperature Controlled Shipments"

Workshop: "Wading through the new Airline Logistics Regulations"

__________________

April 20-21-22, 2009

PDA Annual Meeting

Las Vegas, NV

Presentation: (4/22)  "Advancing Thermal Package Design

by Combining Modern Technologies"

___________________

March 31, 2009

Health & Personal Care Logistics Spring Conference

Philadelphia, PA

Presentation: "Packaging Validation in Distribution"

__________________

March 23-24, 2009

2009 PDA Pharmaceutical Cold Chain Management Conference

Hyatt Regency, Bethesda, Md

Presentation: "Changes in the Air"

The influences of TSA cargo security mandates, an overview of the Certified Cargo Screening Facility program, analysis of airline industry consolidation, lithium batteries Special Provisions Dangerous Goods requirements, and an overview of IATA's new Perishables Cargo Regulations Chapter 17, affecting and impacting time-and temperature sensitive healthcare products.

________________

March 18, 2009

International Air Transport Association (IATA)

Live Animals & Perishables Board (LAPB) Meeting

The LAPB will conduct a one day meeting to review, discuss, and vote on whether to accept the various recommendations of the Time & Temperature Task Force including revisions to the Perishable Cargo Regulations Chapter 17, Air Transport Logistics for Time- and Temperature Sensitive Healthcare Products, guidance on a Quality Management System, and recommnedations for a universal time- and temperature sensitive handling label.

View Article  WHO Final Draft on Storage & Distribution Regulatory Oversight Now Available for Public Review

The World Health Organization (WHO) today released its final draft of Model requirements for the storage and transport of time and temperature sensitive pharmaceutical products for general public review. Review and comment period is open until July 31st, 2010.

This long-awaited guideline prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management, outlines the principal requirements for the safe storage and distribution of time and temperature-sensitive pharmaceutical products. It is based upon existing regulations and best practice guidance from a wide range of international sources, while accepting that local legislation and regulations will continue to take precedence. The final version will be prepared incorporating comments received from this public review. The document will then be submitted to Experts Committee on Biological Standardization and Experts Committee on Specifications for Pharmaceutical Products for their approval in October 2010.

More information, along with a printable pdf. file of the final draft can be downloaded here. Please, forward your review comments on the docucment (no later than July 31, 2010) to:

Dr Ümit Kartoğlu by email kartogluu@who.int
or by fax +41 22 791 4384

View Article  Advanced Degrees: Refrigeration Without Electricity

My column in the May issue of Contract Pharma explores how some archaic technologies, including the Zeer and the Crosley IcyBall, are getting a 21st century makeover.

On a recent flight from Istanbul to Chicago, I noticed a man across the aisle from me in seat 10D, frantically fumbling with his laptop computer. He was clearly agitated that his work was interrupted when he was unable to receive a wi-fi signal — comfortably hurling through the stratosphere as if by magic — at 600 miles per hour, 38,000 feet over the mountains of western Bulgaria. He whines when the flight attendant tells him there is no ice available for his scotch and soda, and he later commented to the woman next to him that his dinner salad was warm and wilted. He would, in less than half a day, be on the other side of the planet among all the modern creature-comforts he has come to take for granted, and all would be right in his world. Incensed by his current state of inconvenience, he grumbles.

Meantime, somewhere in a dry and dusty Nigerian village, a woman prepares a Zeer, two earthen pots the same shape but of different sizes. Read the rest of the article here.

 

The Zeer Pot

 

The Crosley IcyBall