Pharma, Pharmaceutics and Biotechnology Conference

Pharmacovigilance is an important function in the pharmaceutical industry because it focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Once a drug enters clinical trials and eventually reaches the market, the safety of patients can be ensured through careful monitoring and evaluation of the drug throughout the lifecycle of the product. The point at the center of pharmacovigilance is the vigilance for adverse drug reactions.

These may occur during the time of use in a drug's clinical trials or even after it has been marketed and often reveal side effects that were invisible in earlier stages of a drug's testing. Pharmacovigilance teams collect data from various sources: clinical trials, healthcare professionals, and reports by patients, to identify potential risks and mitigate them related to drug use. Post-marketing surveillance has been one of the major components of pharmacovigilance. When a drug is introduced into the market, it comes in contact with a much larger population, and unforeseen side effects appear.

The FDA, EMA, WHO, and other regulatory agencies compelled the pharmaceutical industry to continuously observe the safety of their drugs and inform them of adverse events. Sophisticated drug surveillance systems gather real-time information on the actual performance of drugs and possible risks, to enable pharmacovigilance experts to determine whether a regulatory action is required after all-more precisely, in relation to the modification of labeling text, a dosage change, or a recall-to ensure the safety of patients.

Risk management is one of the principal components of pharmacovigilance that includes RMPs and REMS. The two frameworks depict how firms will monitor, mitigate, and manage risks due to their drugs. Continuous monitoring ensures that the benefits of a drug outnumber its risks. Big data and artificial intelligence are changing the face of pharmacovigilance. The AI-driven platforms should be capable of processing big safety data in real-time, detecting emerging signals related to adverse events, and foretelling potential safety concerns, improving the capabilities of pharmacovigilance teams to expedite the identification of emerging safety issues as well as to enhance drug safety surveillance that becomes more efficient and proactive.

In this session, the participants will be enlightened about why pharmacovigilance plays an important role in protecting public health. A focus could be on best practices in ADR monitoring, progress in the regulatory landscape, and deployment of AI and big data analytics in drug safety surveillance.