Regulatory Affairs and Compliance
Navigating the Future
The regulatory revolution in gene therapy
The cell and gene therapies CGTs landscape is evolving rapidly with transformative potential to potentially cure
Why Early CMC Strategy Matters for Asian Biotech
In July the FDA published Complete Response letters CRLs offering significant transparency
The JAPAC Drug Development Market
Understanding the regulatory landscape and cultural nuances
Regulatory authorities are critical to the development and commercialisation of drugs as they govern the safety
CELL AND GENE THERAPY (CGT)
Key regulatory insights
CGT stands at the forefront of personalised medicine revolutionising healthcare by modifying patients
Unveiling the Evolution
A thought leader's insights into the pharmacovigilance industry
Getting exposure very early on in the science and business of pharmacovigilance was a very fortunate thing for me
UNIFYING DRUG SAFETY
The significance of harmonisation in pharmacovigilance
In pharmacovigilance harmonisation refers to the collaborative effort among regulatory authorities
Nitrosamine Control and Prevention
A comprehensive approach
Nitrosamine describes a class of compounds with a nitroso groups chemical structure bonded to an amine
An introduction to FDA’s Human Factors Engineering Requirements for Drug-Device Combination Products
Although less well known than other drug development phases human factors engineering HFE is critical to meeting regulatory expectations for drugdevice combination products
Technological and Regulatory Changes in Pharmacovigilance
Oracle’s safety management systems
Maintaining regulatory compliance in a global marketplace is increasingly challenging as wellestablished regulators and regional local regulators increase their digital capabilities and expectations of Marketing Authorization Holders MAHs
What Are The 5 Factors You Need to Ensure GMP Compliance?
Video and Article:
This webinar aims to help you understand five critical factors in helping you sustain your GMP compliance It also aims to help you understand the criticality of those factors FDA Inspection Issues Firstly if one were to look at the last three years data on the FDA website and look at the issues
