GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 13 / Year 2024 / Issue 3
Review Article
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Author(s): Vimal Sachdeva, MSc
Page: 151-9Abstract:In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum. A fundamental role of any government is to protect its citizens and promote a healthy lifestyle by ensuring the quality, safety, and efficacy of medical products. […]
Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials
Author(s): Shivani Mittra, MPharm, PhD, Shylashree Baraskar, MBBS, Elena Wolff-Holz, MD, Sandeep N Athalye, MBBS, MD
Page: 141-50Abstract:Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out annually by the pharmaceutical industry. In a world where environmental stewardship, social diversity, and equitable governance (ESG) are progressively becoming biomarkers of business purpose, adopting […]
