Pharmacovigilance

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

Its overall aim is to ensure the safer and more effective use of medicines for everyone.

You will be able to know many important terms, including but not limited to:

1- The pharmacovigilance master file (PMF).

2- The Individual Case Safety Reports (ICSRs).

3- MEDRA (Medical Dictionary of Regulatory Activities)

4- EMA guidelines on good pharmacovigilance practices (GVP).

Business development

is the process that is used to identify, nurture, and acquire new clients and business opportunities to drive growth and profitability.

A business development strategy is a document that describes the strategy you will use to accomplish that goal.

Regulatory affairs

the profession that aims to prepare and submit the e-CTD (Common technical document) to the governments and regulatory authorities in a country in order to get marketing authorization for the company’s medications and products.

Marketing

Marketing refers to activities a company undertakes to promote the buying or selling of a product or service. Marketing includes advertising, selling, and delivering products to consumers or other businesses. Professionals who work in a corporation’s marketing and promotion departments seek to get the attention of key potential audiences through advertising. Promotions are targeted at certain audiences and may involve celebrity endorsements.
catchy phrases or slogans, memorable packaging or graphic designs, and overall media exposure.

Research and development
(R&D)

Research and development (R&D)
includes activities that companies undertake to innovate and introduce new
products and services. It is often the first stage in the development process.

The goal is typically to bring new products and services to market and add to the company’s bottom line.

Quality Assurance

Quality assurance can be defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.” The confidence provided by quality assurance is twofold: internally to management and externally to customers, government agencies, regulators, certifiers, and third parties.

An alternate definition is “all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that  a product or service will fulfill requirements for quality.”

Quality Control

Quality control can be defined as “part of quality management focused on fulfilling quality requirements.” While quality assurance relates to how a process is performed or how a product is made, quality control
is more the inspection aspect of quality management. An alternate definition is “the operational techniques and activities used to fulfill requirements for quality.”