FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

The FDA’s requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products that are permitted under this system of foreign clinical studies include: A human drug A biological drug A medical device […]

The increasing role of the social media in healthcare

  With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare. Whatever the identifiable or unidentifiable reasons for the […]

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the […]

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the subject, and it could be either new […]

What are the components of a Financial Audit Program?

There are various core components of a financial audit program. First, an understanding of a financial audit: A financial audit is a regular exercise carried out by qualified professionals from within or outside, to check the financial health of an organization It involves having to verify, examine and analyze the various data pertaining to the […]

What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed. Logistics and supply chain management is emerging as a […]

The FDA’s Adverse Event Reporting Requirements

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action. The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing […]

Internal Audit Checklist for HIPAA

The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients. The […]

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry. Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech […]