Unitrans Life Sciences Logistics Newsletter | Edition 36 | January 11, 2017
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In Edition 36:
> Temp Controlled Comments
Regulations for Temp Monitoring Devices
IATA Temp Control Courses

> Industry, Carrier and Service Updates
Fastest Growing Pharmaceutical Classes
Newest Medical Device Developments

> Security News
PCSC Conference

> Compliance and Trade Corner
Regulatory System for Biotechnology
FWS Issues Updated CITIES Requirements

Important: Temp Controlled Shipments

New Regulations for Temperature Monitoring Devices

The Lithium battery labelling/marking DG regulations changed as of Jan. 1, 2017. IATA has issued a new label/marking to be used with shipments containing Lithium batteries.

Many commonly used temperature monitoring devices for different temperature ranges are covered by the new regulations and may require specific labeling and declarations on the airway bill. Please contact the device manufacturer for more information. Additionally some re-usable packaging solutions with integrated temperature recording devices also use lithium batteries that because of their size or in combination with additional loggers may require declaration.

For more information about the new regulations please contact Unitrans.

IATA Temp Control Courses

IATA is running a number of courses related to temperature controlled shipments:

Audit, Quality and Risk Management
Time & Temperature Sensitive Healthcare Products
Temperature Controlled Container Operations
Pharmaceutical Handling Diploma

Industry, Carrier and Service Updates

Fastest Growing Pharmaceutical Classes

Luca Dezzani, Global Medical Director at Novartis, looks at the latest findings from the IMS Institute for Healthcare Informatics to derive the top 10 therapeutic classes with highest spending.

Oncologics is at the top with an estimated $83 to $88 billion, almost double the spending of second-placed class Anti-Diabetics.

Newest Medical Device Developments

2017 will see several new and innovative medical devices entering the market. For an overview of the 10 most anticipated devices click here.

Security News

PCSC Conference

Consider attending the PCSC (Pharmaceutical Cargo Security Coalition) conference in East Hanover, NJ to discuss various topics related to cargo security including theft prevention, distribution challenges and new technology solutions. The PCSC is an organization comprised of pharmaceutical industry professionals, law enforcement and government entities, cargo insurers, carriers and risk management advocates.

Compliance and Trade Corner

Regulatory System for Biotechnology Products

On January 4, 2017, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and accompanying National Strategy for Modernizing the Regulatory System for Biotechnology Products.

FWS Issues Updated CITIES Document Requirements

U.S. Fish and Wildlife service has made significant changes to CITES (Convention on International Trade in Endangered Species) requirements.

Questions?  Comments? Ideas? We’d love to hear from you @ marketing@unitrans-us.com

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