Pharma, Pharmaceutics and Biotechnology Conference

An essential domain in pharmaceutical sciences, pharmacovigilance observes, evaluates, and averts adverse drug reactions and ensures drugs are safe during a medicine's lifecycle. With this shift towards the development of additional therapies and their introduction into the marketplace, it has increasingly become apparent why, in the present epoch, pharmacovigilance is so particularly relevant-this being the global health issues created by the COVID-19 pandemic.

This session will delve into the philosophy and practices of pharmacovigilance as a means to help ensure the safety of patients and to shape clinical practice. On a very basic level, pharmacovigilance aims to add to patient safety through the detection, evaluation, and subsequently, reduction of risks from the usage of medicines.

As such, pharmacovigilance uses systematic and rigorous approaches to gathering reports of ADRs and evaluating these for the purposes of gathering evidence that will help design changes to a drug's marketing or usage of such a drug at some future date. Instances of pharmacovigilance activities will also be regulated and directed by important agencies and regulatory bodies, some of which are the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where the action may include satisfying reporting requirements of manufacturers in ensuring safety.

The most important elements involved in the process of pharmacovigilance are data collection and various other sources that help identify the ADRs, such as healthcare providers, patients, and post-marketing studies. It uses detailed data mining techniques and statistical methods to analyze large datasets in the search for potential safety signals and trends.

This way, it involves proactive measures for intervention in a timely manner through label updates or even with safety warnings about information to healthcare providers and patients. Risk management can be included as part of pharmacovigilance, aiming at a balance between the benefits and risks the drug provides. In some medications, REMS are developed to reduce and mitigate risks that the drug may have. This may include restricted distribution, provision for patient education or the conditions for using the drugs. Over the last decade, pharmacovigilance as a discipline has moved on by real-world evidence and patient-reported outcomes to better understand how drugs perform in different populations. Such an important advancement coupled with others, digital health technologies and mobile applications have streamlined ADR reporting where easier communication of safety concerns between patients and healthcare professionals is adopted.

This session introduces participants to the fundamental importance of pharmacovigilance in modern healthcare, best practices and regulatory frameworks, and the impact of new technologies and ongoing challenges in maintaining drug safety.

In fact, it is only through understanding the principles of pharmacovigilance that healthcare professionals can contribute toward safe use and beneficial health outcomes.