Regulatory Affairs
-
Regulatory Affairs
FDARA and Beyond
In a few short years, PBOA establishes itself as a key industry resourceGil Roth, Pharma & Biopharma Outsourcing Association 09.06.17
-
Regulatory Affairs | Supply Chain
Supply Chain Risk Mitigation
Addressing the inherent risks in an increasingly fragmented supply chainNuala Calnan, Lachman Consultant Services 09.06.17
-
Regulatory Affairs | Serialization
The DSCSA Delay What Does it Mean for the Pharma Industry?
What should companies be doing to implement a suitable serialization solution before the new enforcement date arrives?Erik Haeffler, Recipharm 09.06.17
-
Regulatory Affairs
Data Integrity: A Practical and Risk-Based Approach
Ways an organization can form a culture and cost-effective means to meet the various challenges in sustaining data integrity.Robert Marohn, ClinLogic 09.06.17
-
Regulatory Affairs | Serialization
The Psychology of DSCSA: Four Stages of Serialization
It’s time for manufacturers to adopt post-serialization efficiencies.Larry Hotz, Marketing Manager, WDPrx - Woodfield Pharmaceutical LLC 09.06.17
-
Regulatory Affairs | Serialization
Fighting Back!
The drug industry takes a bare-knuckle approach to drug counterfeiters.Daniela Geiger, Vetter 09.06.17
-
Regulatory Affairs | Serialization
Serialization Validation: Right Fitting Your Strategy With a CMO
There are three key factors for manufacturers to evaluate as they define and refine their validation and testing approach.Linda Kristoffersen and David Colombo, KPMG Life Science Advisors 09.01.17
-
cGMP Manufacture | Industry News | Regulatory Affairs
FDA Releases FY 2018 GDUFA Rates
The FY 2018 fee represents a significant drop from FY17's FDF fee of $258,64608.28.17
-
Industry News | Regulatory Affairs
Cingulate, Camargo Enter Regulatory Consulting Agreement
To provide regulatory consulting and strategic development services for two ADHD drugs08.08.17
-
Breaking News | Industry News | Regulatory Affairs
FDA Approves CMP Pharma’s CaroSpir
Spironolactone oral suspension is the only FDA-approved oral liquid dosage form of its kind08.07.17
-
Breaking News | cGMP Manufacture | Industry News | Regulatory Affairs
Senate Passes FDA Reauthorization Act
Aims to allow faster approval of generic drugs and modifies fee structure for various stakeholders08.04.17
-
QA/QC | Regulatory Affairs
India Frames Guidance for Drug Surveillance
Outsourcing PV functions to riseS. Harachand, Contributing Editor 07.18.17
-
Regulatory Affairs
Data Integrity Guidance Around the World
A look at data integrity controls and the overall framework for a data governance system.James Davidson, Ph.D, Lachman Consultants 07.18.17
-
Breaking News | CRO News | Industry News | Regulatory Affairs
Specialist CRO Expands Pharmacovigilance Capabilities
Quanticate makes investment ahead of the upcoming Article 2(3) of Directive 2010/84/EU07.14.17
-
Breaking News | Industry News | Packaging & Tracking | Regulatory Affairs | Serialization
TraceLink Introduces New EU FMD Compliance Technology
Unveils industry’s first Compliance and Digital Information Platform for pharmacies with EU FMD requirements06.07.17
-
Inspections | Regulatory Affairs
-
Regulatory Affairs | Serialization
The EU FMD
Regulatory requirements and key considerations for implementationBrian Daleiden and Caitlin Czulada, VP of Industry Marketing, TraceLink and Manager, Technical Services, TraceLink 06.06.17
-
Regulatory Affairs | Serialization
Lessons Learned From Global Serialization
A look at some key findings leading up to Europe’s 2019 FMDCarlos Machado, Serialization Director, SEA Vision U.S. 06.06.17
-
Regulatory Affairs | Serialization
Adapt Or Die
Contract packaging operations at the center of transition to serializationLarry Hotz 06.06.17
-
Regulatory Affairs | Serialization
The Standards Heard Round the World: DSCSA Legislation and the Global Supply Chain
The more industry members learn from and communicate with each other, the more all of us can anticipate success in implementiHeather Zenk, Vice President, Global Secure Supply Chain Operations, AmerisourceBergen 06.06.17
