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Regulatory: Page 64
Materials
Live from Pharmapack: Protecting Patients Against Falsified Medicines
Breaking news: Regulations such as EU 2016/161, which has to be implemented by February 9, 2019, require innovative solutions to protect patients against falsified medicines.
February 1, 2017
Supply Chain
ACH Foam Technologies: Advanced Cold Chain Shipper
Assures payload temperatures remain between 2⁰ to 8⁰ C for a 24-hr delivery window and is validated to International Safe Transit Association (ISTA) 7D standards.
February 1, 2017
Materials
Predicting the Future of the Global Pharmaceutical Packaging Market
Expansion of generic market, technological advancement, and strict governmental regulations for conventional packaging are major factors that drive the market growth.
January 31, 2017
Medical Device/Packaging
Colorite: Elastomer Compounds
Cellene line of thermoplastic elastomer compounds announced for the North American marketplace for medical device applications.
January 31, 2017
Pharmaceuticals
Ropack Provides International Serialization Hub
Contract development and manufacturing company selects cloud-based system to assist its 130+ pharma customers as they prepare for DSCSA deadline.
January 26, 2017
Pharmaceuticals
Systech Announces Program for Rapid DSCSA Compliance
Ninety-day compliance program enables U.S. pharmaceutical companies that distribute prescription drugs within the U.S. to meet November 2017 DSCSA deadline.
January 26, 2017
Materials
Best Practices for Global Commercial Supply in an Evolving Market
PCI’s Feb. 9 serialization seminar to focus on establishing and developing serialization regulations that vary from country to country.
January 26, 2017
Regulatory
Authentag Introduces UDI Scanning App
Medical device manufacturers must ensure that the FDA GUDID database is kept up to date with unique device information. A new app allows users to obtain GUDID information by scanning the device's barcode.
January 25, 2017
Regulatory
ASTM International Looks At Potential Cannabis Standards, Committee
The green revolution is happening all around us. Are ASTM standards the next step in full-scale public and regulatory acceptance?
January 23, 2017
Materials
FDA Issues Regs on Combination Products
Explains final rule on CGMP requirements for combination products for which the agency issued a draft document in Jan. 2015. No new requirements were established. Postmarketing safety report final rule also provided.
January 23, 2017
Materials
Optima Life Science: Scalable Machine
From laboratory scale to high speed: Converting for transdermal patches, oral film strips and wound dressings.
January 23, 2017
Traceability/Serialization
Rockwell Automation: Updated Serialization System for Pharmaceutical and Medical Device Manufacturers
The serialization solution provides an end-to-end supply-chain platform, and offers an aggregation workflow to help customers using manual aggregation processes.
January 20, 2017
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