The Program

Dealing with the technology and packaging changes needed for a cold chain
Dr Sher Paul Singh
Professor, School of Packaging
Michigan State University

The environment: how ‘green’ is your cold chain?
Tony Wright
Managing Director
Exelsius Cold Chain Management Consultancy

The presence of counterfeit drugs in the cold chain
Ron Ziance
PhD, Professor of Pharmaceutical Sciences
University of Southern Nevada College of Pharmacy

Managing temperature
excursions

Marc Weinzweig
Managing Director and Qualified Person
Biotec Services International Limited

RFID in cryogenic and cold
supply chain for life sciences

Harry P. Pappas
Chief Executive Officer
The RFID Educational Foundation

Day One Tuesday October 21 2008
8:30		Registration
9:00	Rafik H. Bishara PhD, Technical Advisor and Chair, Pharmaceutical Cold Chain Interest Group PCCIG (USA Branch), PDA	Opening remarks from the Chair
Setting the scene with key industry case studies: cold chain within pharma
9:10	Les Sparrow Manager, Quality Assurance and Technical and Support World Courier	Overcoming challenges in clinical cold chain transport Communication and planning: the keys to success Temperature profiling Packaging to protect patients and your IND Chain of custody in transportation SOPs and training
9:50	Hugo Wegewijs Senior Director, European Logistics, Global Biologics Supply Chain Johnson & Johnson and Chair PCCIG European Branch	End-to-end supply chain and channel definition processes at Johnson & Johnson: ensuring patients receive safe and efficacious products Controlling and handling the process from manufacturing through to distribution and final use Increasing the value of our products Our tailored end-to-end methods Deciding which channels are best for our products and patients Gaining greater control of downstream product handling by working closely with supply chain partners and understanding the distribution routes
10:30		Morning refreshments
11:00	Marc Weinzweig Managing Director and Qualified Person Biotec International Services Limited	Cold chain logistics from a QP’s perspective Choice of shipping method Obligations of the QP Validation and control of shipping methods
Harmonizing the industry to simplify distribution
11:40	Rafik H. Bishara PhD, Technical Advisor and Chair, Pharmaceutical Cold Chain Interest Group PCCIG (USA Branch), PDA	Harmonized PDA's technical report number 39: the next steps Why is harmonization important? How we are moving from the ‘whats and whys’ to the ‘hows’ Update on the progress being made
12:20		Networking lunch
Designing an effective end-to-end cold chain strategy
1:30	Nathan Kohner Cold Chain Specialist Almac	Developing a robust clinical cold chain: design and best practice Challenges specific to investigational products Effective shipment preparation Managing couriers Implementing effective procedures and control Examining the increasing requirements for temperate shipping
2:10	Christine Chandler PharmD, Pharmacist Specialist Department of Veterans Affairs	Maintaining quality cold chain storage and shipping in a mail outpatient pharmacy practice Guidance available from USP 1079: procedures on maintaining pharmaceutical integrity throughout the supply chain to the patient Understanding PDA TR-39: global and industry perspectives The role of quality assurance programs for home delivery in ensuring proper handling and education Solutions to logistical issues in shipping cold chain pharmaceuticals: minimizing transport hours, pre-qualified or validated packouts and ongoing temperature monitoring programs
2:50		Afternoon refreshments
3:20	The panel will be made up of speakers from throughout the two days, who will discuss and debate the major topics and questions	Panel discussion: managing the cost of shipping temperature sensitive products Justifying costs to senior management Working in partnership with the finance team Complying with the label temperature while controlling costs Balancing good cold chain performance against cost
Examining the effect of counterfeit drugs
4:00	Ron Ziance PhD, Professor of Pharmaceutical Sciences University of Southern Nevada College of Pharmacy	Counterfeit drugs in supply chains: an international problem Weak and inconsistent regulatory oversight of drug distribution practices between and within countries Skilled practitioners with easy access to materials and equipment Lack of coordinated anti-counterfeiting initiatives
4:40		Closing remarks from the Chair and close of Day One
5:30		Drinks reception sponsored by Almac

Day Two Wednesday October 22 2008

8:30

Registration

9:00

Tony Wright
Managing Director
Exelsius Cold Chain Management Consultancy

Opening remarks from the Chair

Roundtable morning

Delegates will attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to cold chain storage and distribution.

12:30

Networking lunch

1:50

Roundtable summary session
A roundup of key findings and future directions revealed at
each roundtable discussion topic

Cold chain transport in focus: effective time and temperature management

2:20

Raymond Jenkins
Manager, Channel Operations
Graceway Pharmaceuticals

Reducing transit time from Australia to Texas to under 72 hours

Beyond packaging: managing the time while in transit
Producing the correct documentation for customs, HTS number, CAS number and the FDA code number per line item on the commercial invoice
Speeding up customs clearance for cold chain logistics within hours of arrival into US customs

3:00

Dr Sher Paul Singh
Professor, School of Packaging
Michigan State University

Measurement and analysis of physical and climatic changes in container shipments

The Consortium of Distribution Packaging Research projects on the physical and climatic conditions inside container shipments
Discussing the impact of moving and stationary containers during shipments on temperature changes
Physical vibration and shock characteristics of transporting and handling containers

3:40

Afternoon refreshments

4:10

Bob Seevers
Principal Regulatory Scientist, Regulatory Affairs, CMC
Eli Lilly

The proper use of Mean Kinetic Temperature (MKT) for evaluating the impact of temperature excursions during the distribution process on drug quality

Understanding how MKT is calculated, including the impact of using different activation energies for the degradation reaction on the resulting value of MKT
Displaying the proper use of MKT for Controlled Cold Temperature and Controlled Room Temperature evaluations
Assessing the role of stability data in understanding the impact of temperature excursions

4:50

Closing remarks from the Chair and champagne prize draw