Regulatory: Page 73

Regulatory
LIVE FROM PDA/FDA: An Overview of FDA’s Expectations of Biosimilars
Similar biological medicinal products are not the same as small-molecule generics in terms of their complexity or the approval process, which evaluates residual uncertainty at each step.
September 14, 2016
An Overview of FDA’s Expectations of Biosimilars
Packaging/Filling
NJM Packaging: Dara Moduline NFL
Dara’s aseptic fill-and-finish system is integrated with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment.
September 14, 2016
NJM Packaging: Dara Moduline NFL
Materials
LIVE FROM PDA/FDA: Compliance to Quality: Part 2
Retired Amgen Chief Quality Officer discusses building a quality culture from the top.
September 14, 2016
Shown here is an insulin vial and ampules.
Pharmaceuticals
LIVE FROM PDA/FDA: Compliance to Quality: Part 1
CDER’s Office of Pharmaceutical Quality aims to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies.
September 14, 2016
LIVE FROM PDA/FDA: Compliance to Quality: Part 1
Pharmaceuticals
LIVE FROM PDA/FDA: Regulated Biologics Offer Therapeutic Promise; Manufacturing Challenges
Many genetically modified cellular therapies are developed with relatively small safety and efficacy datasets from clinical trials. As a result, some are eligible for orphan designation, which allows for fast-tracking to market.
September 13, 2016
Seen here are tissue culture flasks.
Materials
LIVE FROM PDA/FDA: Industry Mobilizes to Fight Falsified Medicines
Pfizer representative emphasizes the significance of supply chain security from raw materials and APIs to pharmacies.
September 13, 2016
Industry Mobilizes to Fight Falsified Medicines
Materials
LIVE FROM PDA/FDA: Pharmaceutical Inspection Cooperation Scheme Seeks Global Harmonization
PIC/S membership is growing worldwide, yet China and India face regulatory and economic challenges.
September 13, 2016
LIVE FROM PDA/FDA
Pharmaceuticals
LIVE FROM PDA/FDA: FDA Continues Focus on Keeping Public Safe in the Fight Against Counterfeit Drugs
FDA has made strides in identifying vulnerabilities and threats in the supply chain with the implementation of the DSCSA.
September 12, 2016
LIVE FROM PDA/FDA
Supply Chain
Determining the Impact of Packaging and Logistics on the CAR-T Clinical Pipeline
Sept. 14 presentation addresses the systematic study of the impact of logistics decisions on the integrity of critical biomarkers and active clinical product and data generation.
September 12, 2016
Determining the Impact of Packaging and Logistics on the CAR-T Clinical Pipeline
Labeling/Printing
Rechon Life Science Employs Scalable Serialization/Aggregation
Sweden pharmaceutical maker and CMO partners adds Adents software on its printing equipment to offer its customers scalable track and trace.
September 9, 2016
Rechon logo
Medical Device/Packaging
Materials for Medical Device Packaging
Here’s a roll call of the major materials that go into medical device packaging.
September 5, 2016
Sterling Anthony, CPP
Regulatory
Packaging for Clinical Trials
With different users, logistics, regulations, and volumes, designing packaging for clinical trials brings its own challenges. Be sure to consider the following in your design phase.
September 1, 2016
Packaging for Clinical Trials
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Top Stories
Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
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