Drug Development Process – From Discovery to Marketing

Overview: This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. […]

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right. FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, […]

Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands. The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for […]

Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It […]