Clinical Drug Development process and it’s Online Training
Developing a new drug from original idea to the launch of a finished product is a complex process which can take 12–15 years and cost in excess of $1 billion. A drug discovery programme initiates because there is a disease or clinical condition without suitable medical products available and it is this unmet clinical need […]
Computer System Validation (CSV) In Pharmaceutical Industry
Computerized system validation (CSV) (usually referred to as “Computer Systems Validation”) is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used […]
Pharmacovigilance: Post Pandemic
Get Best training and certification in Pharmacovigilance  The History of Pharmacovigilance roots back to the rise in awareness among clinicians and the public pertaining to the safety of drug use in the middle of 20th century. Despite concerns around health issues due to adverse reactions caused by intake of medicines, the discipline and practice […]
Medical Writing
Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines are all exerting pressure on pharmaceutical companies to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core […]
Herbal Drug Regulatory Affairs
Herbal medicines, known as phytomedicines or botanical medicines (Phyto- Plant) contains plant parts like, leaves, roots, stem, flowers, and seeds for therapeutic purpose. It is the oldest and still most generally used system of medicine in the world at present. 80% of the world population relies on herbal medicines as their primary healthcare system. Get […]
Regulatory Medical Writing
Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval. A crucial component within this process is well-developed, well-documented, and well-communicated study research practices. Medical writers act as key communicators for study sponsors and governmental agencies, such as the U.S. Food and Drug Administration (FDA) and […]