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Thursday, March 27

World Health Organization Takes Cold Chain Management Training On The Road
by
Kevin O'Donnell
on Thu 27 Mar 2008 11:07 AM CDT
he World Health Organization (WHO) Department of Immunization, Vaccines and Biologicals (IVB), Quality, Safety and Standards (QSS) team support countries and vaccine manufacturers to strengthen and expand capacities in vaccine regulation. Along with this support, WHO/IVB/QSS manages a Global Training Network on Vaccine Quality (GTN/VQ) through its accredited training centres and delivers various training courses.
Pharmaceutical cold chain management on wheels is a new WHO and Parenteral Drug Association (PDA) training course offered in association with Tip Kurumu (Medical Society - Turkey), Cool Chain Association, DHL, Pfizer, Selçuk Ecza Deposu (Selçuk Warehouse Pharmaceuticals), Hacettepe University Hospitals, Turkish Pharmacists' Association and the Ministry of Health of Turkey. 2008 course will take place in Turkey between 2-7 June.
Primary target audience
· Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: Supply, packaging, distribution, logistics and cold chain management. Manufacturers who already supply WHO prequalified products are encouraged to participate.
· Representatives from the equipment and device manufacturing industry in the areas of: Active cooling, passive cooling, temperature monitoring, and track and trace. Manufacturers who already supply WHO PQS prequalified products, or who wish to enter this market, are encouraged to participate.
· Representatives from logistics providers.
Secondary target audience
· Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: R&D, quality, regulatory, and manufacturing.
· Representatives from the government sector including military services involved in pharmaceutical cold chain in the areas of: regulation, inspection, planning and monitoring.
· Representatives from WHO, UNICEF and other partner organizations: Technical officers responsible for pharmaceutical cold chain management activities at regional level, intercountry logisticians, health officers, EPI officers, and immunization advisers whose involvement in pharmaceutical cold chain is confirmed by their organizations.
· Members of the faculty of institutions of higher education in health professions.
· Independent consultants
APPLICATIONS and SELECTION PROCESS
Representatives falling into above mentioned primary and secondary target audiences should apply directly to GTN/VQ secretariat with the attached GTN/VQ application form. Applicants should send their applications along with their CVs to the following addresses:
Dr Ümit Kartoğlu kartogluu@who.int and Ms Sinéad Jones jonessi@who.int by email or +41227914384 by fax.
Deadline for application is 15 April 2008. Following this date, all applications will be evaluated by the WHO GTN/VQ secretariat and acceptance letters will be sent the following week.
You can link directly to the WHO website and the applicable documents below for further details.
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Introduction document
Application form
Information bulletin
Thursday, February 21

Tour Dates
by
Kevin O'Donnell
on Thu 21 Feb 2008 10:41 AM CST
I will be traveling most of the month of March, participating at symposiums, conferences and trade shows and I hope to see you at one or the other.
The first event is the The International Air Transport Association (IATA) World Cargo Symposium 2008, in Rome, Italy, March 3-6. My wife, Colleen, and I are headed over a few days early to enjoy a long weekend in the Eternal City prior to the Symposium. I will be chairing the one-day Pharmaceutical Track, the first the airlines' Live Animals & Perishables Board (LAPB) has ever devoted to our industry. You can view the agenda here.
The following week I will be in Bethesda, Maryland to present at the Parenteral Drug Association (PDA) Cold Chain Management Training Conference and Exhibition, March 13-14.
I will deliver a presentation on Friday, the 14th. "Where is the Evolution of Thermal Package Design Headed?: Combining Technologies to Optimize Package Performance."
This thirty case study explores how segments of the testing industry and academia are blending innovative and efficient applications of computer-aided design, finite element analysis, and proven mathematical models, to accurately predict thermal performance, accelerate the design process, reduce physical testing, and increase design confidence for insulated packaging systems.
The science-driven approach uses multiple technologies in concert, providing for a more elegant solution over a single application or current iterative methodology.
It also provides for documented evidence for the Design Qualification (DQ) of insulated packaging systems recommended in PDA Technical Report No.39, Sec. 6.3).
In addition to the technical conference, my colleagues and co-instructors, Rafik Bishara and Tom Pringle, will conduct a 2 day Cold Chain Management Training Course, March 11-12, through the PDA Training & Research Institute. A pdf of the agenda here.
The final week in March you can find me at Interphex 2008 at the Pennsylvania Convention Center in Philadelphia, then its back to Europe to attend the IATA LAPB annual meeting in London, as a member of their Temperature Control Task Force. I'm sure the topic of label requirements for temperature sensitive medicinal freight will be a major topic of discussion.
Monday, December 17

IATA World Cargo Symposium
by
Kevin O'Donnell
on Mon 17 Dec 2007 02:09 PM CST
The International Air Transport Association is hosting it's World Cargo Symposium, March 3-6, 2008 in Rome, Italy. The theme this year is "Focus on the Customer". A one-day pharmaceutical Forum entitled "The Cure is in the Air" is scheduled on the 5th. IATA is offering a reduced early bird registration fee through mid-January, coupled with a chance to test drive a Ferrari.
This is the first public forum in which IATA has extended an open invitation to the pharmaceutical industry - looking specifically for their feedback and recommendations.
This is a terrific opportunity for the bio-pharma industry to work in partnership with the airline industry whose services are so critical for the delivery of their products worldwide.
Link to the World Cargo Symposium agenda for the Pharma Track here.
Wednesday, October 10

IATA Announces Details of World Cargo Symposium 2008
by
Kevin O'Donnell
on Wed 10 Oct 2007 10:57 AM CDT
For its second edition, The International Air Transport Association (IATA) is assembling over 20 cargo events in one single gathering, including a dedicated track on pharmaceuticals, for their World Cargo Symposium, March 03 - March 06, 2008 in Rome, Italy, at the Rome Marriott Park Hotel Centre.
I have been invited by IATA to chair the one day Pharma Track on March 5th.
I believe this will provide a significant opportunity for members of the biopharma industry to join with colleagues and experts from around the world to discuss the challenges and propose solutions regarding global air freight logistics with key members of the airline industry in an effort to improve distribution management practices for temperature-sensitive medicinal freight. Also, it will provide an opportunity to discuss the impact of the new Perishable Cargo Regulations Chapter 17 Air Transport Logistics for Temperature-Sensitive Healthcare Products which went into effect July 1st, 2007.
The IATA World Cargo Symposium concentrates decision makers, key stakeholders, cargo specialists and business owners, to share the latest knowledge, best practices and benchmarks around one theme: Focus on the Customer.
Over 800 cargo professionals from around the world participated in the first International Air Transport Association (IATA) World Cargo Symposium, which took place 5-9 March, 2007 in Mexico City. This one-week global mega-conference assembled 13 workgroup committees, 8 forums, 2 plenary sessions, 140 speakers, 28 exhibitors and 12 sponsors in one single gathering.
Registration and additional information is provided in the links above.
Monday, August 13

PDA Schedules 2nd European Conference & Training for Pharmaceutical Cold Chain Management
by
Kevin O'Donnell
on Mon 13 Aug 2007 03:32 PM CDT
The Parenteral Drug Association (PDA) the global organization committed to the advancement of science and technology of bio-pharmaceutical products, has announced details of their 2nd European Cold Chain Management Conference.
This years' conference will be held at the Hotel Melia in Berlin, Germany, on October 17-18, 2007. In addition, the PDA has organized a two day "Good Cold Chain Management Training" course preceding the conference on October 15-16, 2007.
This year's seven plenary sessions will focus on relevant topics for those involved with cold chain and temperature controlled management practices including:
Ensuring optimal potency of vaccine by evaluation of stability data - Umit Kartoglu, PhD., from the World Health Organization
Risk management approach to shipping and distribution of temperature-sensitive products - Gwen Murdoch, Eli Lilly & Co.
An overview of IATA's Perishable Goods Regulations - (yours, truly)
And a mathematical approach to assessing temperature excursions in controlled distribution chains - Claude Ammann, Apoxis SA
I was asked by Rafik Bishara, the Conference Chair, to moderate the "Partners in Supply Chain" Session and help develop and co-present the two day training course for the PDA, along with Rafik and Tom Pringle, formerly of ISC.
"Good Cold Chain Management Training" will focus on two topics.
Day one includes: Global Regulations & Standards and Influences on Cold Chain Distribution Practices;
Day two: Development & Testing of Cold Chain Packaging and Transport Systems.
I was not able to make last year's conference due to a schedule conflict and I am looking forward to learning from what appears to be a full agenda of distinguished speakers - many of whom will be presenting at the PDA for the first time. Given the PDA's previous success in Bethesda, MD earlier this year (see related posting dated June 18, 2007) and in Berlin last October, (see related posting October 11, 2006 in the archives) this year's European event promises to out due itself. I hope to see you there.
I have attached a pdf copy of PDA's brochure for the event for your convenience.
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