Pharma, Pharmaceutics and Biotechnology Conference

Clinical and Regulatory Affairs-the Imperative Components of Pharmaceutical Development: Clinical and regulatory affairs are some of the most important functions in the pharmaceutical industry.

As new therapies are developed and ready for market entry, these two functions ensure that there is heavy implementation of the idea while still observing lawfulness, as both clinical and regulatory affairs work hand in hand to make it possible.

This session ""Clinical and Regulatory Affairs"" will look at the complexities of clinical research and regulatory compliance, exploring strategy toward the successful development of drugs that permit access to markets in a timely manner.

The discussion will outline the clinical trial process, from the early phases of clinical research-to be focused on safety and dosage-to late phases, which focus on efficacy and long-term effects.

Attendees will be introduced to the most important issues related to design in conducting trials, such as selection of endpoints and issues with regard to patient recruitment, including statistical considerations and their impact on regulatory submissions.

Diving deeper into the regulatory affairs will, subsequently, highlight a compelling reason to understand and appreciate these regulatory frameworks and requirements.

To that end, some of the main regulatory agencies will be specifically discussed in some depth, focusing particularly on FDA in the United States of America and EMA in Europe, and considering their roles in the drug-approval process. Participants will gain understanding about the nature of different types of regulatory submissions, for example, IND applications, NDA, and BLA, and grasp the role of a pre-approval inspection as well as the importance of compliance with GCP.

For instance, it will tackle the trend on emerging trends in regulatory affairs ranging from increasing requirements on real-world evidence (RWE) towards increasing accelerated pathways to approval.

Participants will learn how such trends alter the regulatory environment and open up new paths to faster access for innovative medicines to patients who need them. Collaboration between clinical and regulatory teams will play an important role in coordination regarding the strategies required by overall clinical development that are aligned well with regulatory expectations.

This session provides practical insights as it is a department-to-department collaboration that will help optimize the ease with which smooth drug development processes move toward regulatory approval. Through attendance, participants will gain and in-depth understanding of the complexities surrounding clinical and regulatory affairs.

The knowledge and skills acquired will enable participants to understand how challenges of drug development can be dealt with.

This session will be useful to clinical researchers, regulatory affairs professionals, and healthcare providers who will want to know best practices and strategies of attaining compliance in order to have new therapies brought to market safely and efficiently.

Attendees will learn effective clinical and regulatory strategies that should be implemented in their organizations in order to identify actionable knowledge supporting their contribution to the successful development and approval of new drugs and therapies.