Regulatory Medical Writer

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 possess knowledge of the regulatory framework, guidelines, laws and regulatory processes.

Herbal Medicines: A Pharmacovigilance Priority

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 medicines should be followed worldwide just as conventional pharmaceutical drugs.

Pharmacovigilance interview questions and answers for freshers: Part 2

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 level.

Pharmacovigilance Interview Questions and Answers For Freshers – Part 1

In every interview that you might attend, you always wish to know the questions beforehand. However, you should keep in mind that the panel sitting in front of you is experienced and can go a step higher if you can steer clear from their simple volleys. No list of questions or guide is perfect but they all are for the preparation of better good. We bring forth to you a list of few academic questions that might make the tortuous path a little easier.

Healthcare Marketing in India: A growing Industry

Healthcare Marketing

India is a witness to a change. There is an accelerated growth of healthcare industry with sprouting of hospitals, at a pace which, is, entirely difficult to fathom. The healthcare market is seeing both private as well as foreign investments as the Indian health care market is expected to grow by a rate of 15 percent in the coming 5 years. However the challenges faced by both the new or old hospital sectors are Healthcare marketing.

Dawn of Pharm D in India

In the United States and other foreign countries a pharmacist is allowed to practice clinical pharmacy. A statutory system exists wherein the diagnosis is carried out by doctors and then the patient is sent to the pharmacist who prescribes medication and charge for it. Pharmacists are highly salaried in the US where their average salary is around 40-50 USD or even more per hour. India is taking its initial steps in instituting such a system by bringing about remarkable changes in the pharmacy profession.

Telemedicine: A New Way Forward

Telemedicine: What does it Feature

Telemedicine is not a new means of conveying healthcare benefits to society at large but rather an old way modified by new technologies. Earlier ballads would sing the stories and convey information to the community and now we have telemarketers doing the same the only difference being today’s advanced communication technologies are able to provide healthcare services to even a distant source in a fraction of a second and make the two way communication between the patient and practitioner quicker, easier and faster.

Medical Journalism in India

What is medical journalism?

As the name implies, medical journalism refers to reporting of medical news and features. It is of two types – one which is intended for general public featuring medical news in general publications and the other for doctors and healthcare professionals in peer reviewed journals. In short, medical journalism is all about understanding scientific news and conveying them to a non-specialist audience in a remarkable way. There is a scope for a lot of inaccuracy and speculations in medical news coverage owing to several barriers such as the gap between the scientific community and general public, lack of expertise in medical news reporters as most of them come from backgrounds other than science and space constraints in the publication.

How to become a Regulatory Affairs Specialist?

Anyone who has an interest in the regulatory field must have a very pronounced love of detail. … While the regulatory elements of a job like this can be learned, if you can’t manage tiny nuances of data in a multigigabyte document, you’re in trouble.

–Shannon Strom

A Senior Regulatory Scientist

Regulatory Affairs Career Path

What is the need for regulatory affairs?

Have you ever wondered who protects public health by ensuring the quality, safety and efficacy of drugs we consume? We all know that a new molecule costs several millions of bucks. At the same time, lack of proper regulation of these drugs can cost several lives. Another thought to ponder is that it takes not less than 15 years to develop and release a new pharmaceutical product. It involves research and development, different phases of clinical trials, regulatory submissions, manufacturing and marketing, distribution and post-market surveillance.

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