Related Experiment Video
Updated: May 12, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
[Regulatory science: modern trends in science and education for pharmaceutical products]
Abstract:
This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).
More Related Videos
11:01Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids
Published on: September 25, 2016
07:43A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
Published on: July 14, 2023
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
FDA Approved Drugs: Changes to Approved Drugs
Biopharmaceutical Factors Influencing Drug Product Design: Overview