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Prof. Dr. Yvonne Ziegler, is CEO at Mytigate and Full Professor of Business Administration with special focus on Aviation Management at Frankfurt University of Applied Sciences.

Dr. Vincenzo Uli is Product Owner at Mytigate and Research Associate of Business Administration at Frankfurt University of Applied Sciences.

Articles

For pharma companies, an investment in a digital risk management tool is worth considering if they want to meet the European Union's regulatory requirements for pharmaceutical transport and wholesalers

Ensuring Compliance and Quality of Pharmaceutical Transport

Steven Lucio is responsible for providing education to member organizations and supporting their efforts on various clinical practice topics, including improving medication safety, mitigating the impact of drug shortages, benchmarking pharmacy costs for key drug classes, evaluating the expense of high-cost biologics and preparing for the future development of biosimilar medications.

 currently serves as Vizient’s senior regulatory affairs and public policy director. In this role, she identifies and responds to legislative and regulatory developments of most interest to Vizient members. Medicare reimbursement and prescription drug policy are among the topics which Jenna focuses on at Vizient.

FDA’s Unapproved Drug Initiative (UDI) is a well-intentioned program in its encouragement of formal FDA review for unapproved legacy medications. But it has inadvertently created financial challenges and access issues, write Steven Lucio and Jenna Stern

Exclusivity Creates Challenges in Price, Access for Long-used Medications

Tracy Nasarenko is Senior Director Community Engagement at 

From November 2023, the Drug Supply Chain Security Act requires healthcare manufacturers, distributors, providers, and dispensers to exchange the serialized item-level product information that has been collected, standardized, and digitized. Hitting this deadline hinges on intensive collaboration between manufacturers and their supply chain partners that must begin now

Flipping the Switch on DSCSA Interoperability

Trading partner Interconnections via the EPCIS standard is a basic requirement

Industry Readiness for DSCSA Compliance is “Progressing” but Far from Complete, says HDA

It has become critical to provide real-time accurate labeling information to labeling teams and healthcare providers as soon as a product change is approved by regulators. IQVIA‘s Cham Williams discusses the technology needed to support this shift and how these new solutions will minimize risks associated with regulatory compliance and increase patient safety.

Leveling Up with Labeling Technology

GTS improvements include additional data integrity protection, greater Level 1 and 2 equipment compatibility 

Antares Vision Boosts Global Tracking System Software

Publication finds that only about 40% of retail pharmacists feel equipped to discuss biosimilars with patients 

Cardinal Health Releases 2022 Biosimilars Report

The solution is a combination of cold chain logistics, serialization compliance and distribution 

Thermo Fisher Scientific Unveils New CGT Services

Software firm merges with PharmaLex Group

Pharmasol Expands Pharmacovigilance Presence

Action offers the fulfillment of a critical part of the Drug Supply Chain Security Act (DSCSA)

Legal and Regulatory