Industrial Twist to Ethics Pharmaceutical companies invest large amounts of money in developing new drugs. When high stakes are potentially involved unethical practices can leech in such as increasing the clinical effectiveness of drugs and suppressing or overlooking, the safety concerns thus creating a bias. Conducting clinical trials needs to follow stringent ethical guidelines and […]
Medical writing is a very broad discipline and medical writers are required by diverse establishments like the pharmaceutical companies, clinical research and development companies, academic content development companies or publishers, medico-marketing agencies, food product manufacturers, healthcare institutions, etc. Medical writers use their scientific knowledge in conveying comprehensive and organised information to the target audience. This inspiring […]
Medical and health information are collected, organized and presented by medical writers to the target audience. Medical writing involves communicating scientific data in a clear and convincing way. Demand for Medical Writing A Medical writer has to collect and compile medical or scientific or clinical data from various sources. The scientific or medical information is […]
Clinical research is a well established and prosperous field of science across the globe and is emerging as one of the major drivers of better healthcare delivery. It helps innovative drugs and interventions for prevention and treatment of various diseases to enter worldwide market. The increasing demand and booming market of clinical research provides better […]
Private, government and other non-profit stakeholders have collaborated to build a global health safety culture. The professionals of pharmacovigilance have adapted with advances in technology, product innovation and regulatory changes to insure drug safety worldwide. Scope of Pharmacovigilance Pharmacovigilance stands for vigilance of medicines or pharmaceuticals and other medical products available for prevention and treatment […]
Pharmacovigilance is a pharmacological science ensuring drug safety and efficacy. It focuses on prevention of adverse drug reactions (ADR), medication errors such as overdose, misuse and abuse of a drug. The aim of pharmacovigilance is to improve public healthcare and enforce safe usage of medicines. In many countries, the importance of pharmacovigilance in drug research and development is growing. […]
Pharmacovigilance involves assessing the risks associated with pharmaceuticals and medical devices and ensuring drug and device safety. Many career opportunities are available in the field of drug safety or pharmacovigilance. Individuals attempting to enter into this field should have degree in life sciences or nursing, pharmacy or medical degree. There are also various courses available […]
A regulatory medical writer is a technical communicator with writing skills that specializes in preparing documents to meet requirements of regulatory authority. A regulatory medical writer has to collect technical specifications from medical workers arrange the information and prepare documents in compliance with regulatory authority. Apart from a knowledge about technical processes regulatory writers must […]
Herbal Pharmacovigilance Pharmacovigilance (drug safety monitoring) is mandatory for acquiring information on the safety of drugs and herbal medicines are no exception to the rule. South-Asian countries like India, China, Thailand highly believe in and propagate traditional medicines however there is no coherence regarding regulation and monitoring of these herbal products. Stringent guidelines for herbal […]
What is GVP? Good Pharmacovigilance Practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national […]