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Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials


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Events – Free Webinar Recording Now Available

Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials

Webinar Summary
Temperature excursions of cold-chain clinical trial materials (CTMs) and investigational medicinal products (IMPs) can significantly alter their efficacy and potency. With many clinical specimens required to be frozen at -78.5 degrees Celsius or maintained at refrigerated temperatures between 2 and 8 degrees Celsius, even temperature variations of just a few degrees can affect the integrity of the specimens.

The end result of a compromised or an adulterated CTM/IMP is a delay of introducing the new medicine to the patients and loss of priceless time. Each passing day that the drug is not approved by the regulatory agencies such as the U.S. Food and Drug Administration is a day of lost revenue for the developing organization. More important, if temperature excursions were to go unnoticed, it could cause harm to patients involved with the clinical trial or negatively affect the outcome of the trial due to a lack of consistency of drug efficacy.

As clinical studies move beyond primary cities and into more remote investigator site locations, there are new challenges to maintaining the cold chain. Components of a clinical trial often occur in different countries, which have their own regulations regarding the clinical trial process. Additionally, because of the various exchange and drop-off points, distribution environments often involve lengthy clearance procedures at customs, several modes of transportation, numerous carriers and couriers, specialty packaging solutions, different climate zones and seasonal changes.

Thus, temperature control during the handling, storage and distribution of these cold-chain products is not only challenging but also critical.

Learn the safeguards to protecting CTMs/IMPs as they progress through the global cold chain in this Webinar, titled “Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials.” This presentation will outline some of the risk points that must be considered when selecting a packaging system, choosing your transportation partners and developing a contingency plan.

PCCDG Chair Dr. Rafik H. Bishara will give a review of global regulatory and standards-based guidance for Good Cold Chain Management Practices covering CTMs/IMPs – including:

	Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Storage Practice (GSP)
	United States Pharmacopeia <1079>
	Health Canada
	International Conference of Harmonization (ICH)
	World Health Organization (WHO)

World Courier Director Michael Connolly will highlight the practical application of these regulatory requirements and guidance standards with case studies and detail how industry leaders are taking steps to reduce risk and provide exemplary management of cold chain logistics and shipments.

Following Mr. Connolly’s presentation, Sensitech’s Director of Strategic Marketing for Life Sciences, Henry Ames, will give a brief description of Sensitech’s validated temperature data loggers and professional service offerings. These solutions are geared toward meeting regulatory demands and mitigating risk.

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Rafik H. Bishara, Ph.D., Technical Advisor
is the current Chair of the Pharmaceutical Cold Chain Discussion Group (PCCDG), Parenteral Drug Association (PDA). Dr. Bishara retired from his position as Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company after a 35-year career. During his tenure at Eli Lilly and Company, Dr. Bishara was responsible for the Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. Dr. Bishara frequently chairs and presents at industry leading conferences, has authored numerous articles, and technically advised several organizations on Good Cold Chain and Temperature - Controlled Management Practices. Dr. Bishara received his Ph.D. from Purdue University, Indiana, USA.

Michael Connolly, Director of U.S. Operations, World Courier Inc.
is responsible for the day-to-day management of 12 World Courier offices in the United States. He is also the president of its brokerage division, World Customs Brokerage, Inc., and the quality control manager of its ISO 9001 program. He is an active member of several professional transportation organizations and a member of World Courier’s Temp Control Advisory Committee. Mr. Connolly holds a bachelors degree in sociology from the State University of New York at Stony Brook and is a licensed U.S. Coast Guard Captain.