A medicine is essential for treating a disease. Thus care has to be taken that it is safe to use, has high efficacy in treating a disease without any adverse side effects and that’s where a regulatory professional plays a role. Regulatory affairs is essential aspect of each industry for controlling safety and efficacy of […]
Various companies, organisations and healthcare are tracking key regulatory compliance trends and developments to be addressed in 2019. Regulatory compliance Regulatory compliance is created with intention to heighten scrutiny and positively impact the manner in which products or services are produced and delivered. Regulatory compliance provides guardrails with an overall mission to serve and protect […]
India is associated with huge number of clinical experts; quick patient enrolment process; large pool of subjects; low cost and better management tools or databases, thus, offering better job opportunities in the field of clinical data management. Clinical Data Management Courses Data management includes data validation and storage; data privacy, data processing and protection; good […]
Pharmacovigilance: An overview Pharmacovigilance deals with prevention of any adverse reaction caused by a pharmaceutical product. It is primarily drug safety related to the collection, detection, assessment, monitoring, and prevention of the adverse effects. A large number of drugs are withdrawn or banned in the market as a result of the work done in this […]
Why Clinical Research? Clinical research industry has a high potential for growth and there is a large gap between demand and supply due to lack of highly qualified individuals with skills and expertise to conduct and manage clinical trials. It provides professional growth in terms of avenues, jobs as well as hierarchical growth without stagnation […]
Good Clinical Research Practice (GCP) helps design, conduct and report clinical research in an ethical and scientific manner. Various training programs are commissioned to train a cadre of clinical researchers on using global standards tools and systems for developing and conducting clinical trials on public health products like vaccines, drugs, biologics, medical devices or healthcare […]
Pharmaceutical Regulatory Affair All aspects of the pharmaceutical industry related to products, processes, documentation, service delivery, research or testing procedures, manufacturing and packaging are guarded by regulations. The legislations are carved to pave the safest path for streamlined journey of the products from the company to the consumers in the market. These rules, guidelines and […]
Life of a Medical Journalist A Medical journalist reports various aspects of therapeutics and healthcare ranging from information for the general masses to writing research or condensing the various research data available for medical professionals. However medical journalism may not always be accurate and unbiased. It needs to be verified at various levels because a […]