Pharma, Pharmaceutics and Biotechnology Conference

From clinical trials to pharmacovigilance, the core of new drug development and post-launch surveillance is to ensure that a new therapy is both safe and effective enough for its introduction in the public health domain.

This conference session will go into their crucial roles in pharmaceutical research, importance in risk reduction, and best outcomes among the patient population. Clinical trials are the most critical phase of drug development, testing a new therapy in terms of efficacy and safety in its intended setting before it is approved for use in the general public.

This session deals with various phases from Phase I. Focus areas will include adaptive trial designs and RWE, which may help further drive efficiency in trial processes and bring innovative therapies to market more quickly. The one important area of clinical trials is patient safety.

In this session, we will cover monitoring adverse events (AEs) and how clinical trial teams identify potential risks early on in the development process so that only the best and safest drugs are pushed forward in further development phases.

As critical pharmacovigilance, or drug safety monitoring, is to a drug prior to its introduction to the marketplace; it is just as critical once in the marketplace. It's one thing when a drug first gets its approval-although that post-marketing safety evaluation to monitor unsuspected adverse effects remains essential.

The session will focus on tools and strategies applied in pharmacovigilance-including spontaneous reporting systems, electronic health records-mined data, and patient-reported outcomes.

This would simply mean that the risk-benefit profiles of such a drug are always scrutinized by healthcare professionals and regulatory bodies themselves, with the former always keeping the safety of the patient at the top of their list of priorities.

Regulations concerning Pharmacovigilance and Clinical trials will also be discussed during the session, in which companies will understand the broad landscape of regulations around the world and how to stay compliant in such an aggressive regulatory environment.

Public awareness coupled with increasing regulatory scrutiny drives the paramount of having a strong pharmacovigilance system.

The participants in this session will take back complete knowledge on how clinical trials and pharmacovigilance contribute to the successful development and safe use of pharmaceutical products.

Whether drug development, regulatory affairs, or healthcare delivery are involved, participants will learn some very relevant information on processes that protect patients and uphold pharmaceutical innovation integrity.

Attendees will be able to leave the meeting armed with practical knowledge about best practices in the design of trials and risk management in general, and post-market safety monitoring of those products, hence helping to contribute to the continued success and safety of modern therapeutics.