Aptar Pharma, a global leader in drug delivery systems, components, and services, and Nanopharm are excited to announce their upcoming expert-led webinar titled, “Advancing Inhaled & Nasal Drug Clinical Studies: Navigating Clinical and Regulatory Pathways for Optimal Outcomes.” This insightful event aims to empower professionals in the pharmaceutical domain by addressing the complexities and nuances associated with nasal drug delivery and clinical studies.
During the webinar, participants will have the opportunity to understand FDA expectations for nasal drug delivery systems, differentiate between CMC requirements for commercial products vs. clinical trials, learn necessary testing protocols to support clinical trials and discover development considerations pre IND (Investigational New Drug).
The webinar will delve deep into the meticulous pathways of clinical studies for OINDPs, providing expert guidance on regulatory dossier guidance, emphasizing the importance of balance and precision in preparation and execution. Participants will learn the importance of preparing optimally without under or overdoing activities, and they will gain insights on making judicious decisions through seasoned partners.
Aptar Pharma will also guide participants through prevalent pitfalls and critical factors encountered during preclinical, early, and late clinical development phases, ensuring an accelerated and risk-averse approach. The discussion will also encompass the specifics of required tests, target validation levels, and the varying expectations of different regulatory agencies while reviewing studies.
Participants will also be shown strategies that mitigate risks in CMC studies by considering them in the early phases of development. This proactive approach ensures optimal performance and averts indulgence in obsolete tasks, streamlining the path to final formulation.
The sector of orally inhaled and nasal drug products (OINDPs) is witnessing remarkable growth. This webinar will highlight the importance of collaborating with experts proficient in the intricacies of device, drug, formulation, and analytical activities within combination product development. A comprehensive perspective is pivotal to appeasing regulators and streamlining clinical development from inception to completion.
Both Aptar Pharma and Nanopharm are committed to advancing the field of nasal drug delivery, and this online event will provide a comprehensive understanding and strategic approach to inhaled and nasal drug clinical studies. It is an opportunity for pharmaceutical professionals and organizations to enhance their knowledge and strategies involved in the development of nasal drug products and to be apprised of the evolving trends and regulatory expectations in nasal drug delivery systems.
Registration is now open, and attendance is free. To reserve your spot, please click on the links below.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has approximately 13,500 dedicated employees in 20 countries.
For more information, visit www.aptar.com/pharmaceutical
Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research organization (CRO) offering product design and development services for orally inhaled and nasal drug products (OINDPs). Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products from discovery through to clinical investigations (‘IND’). Its service offerings provide the most efficient path to success for its clients by providing an integrated drug development service.
For more information, visit www.nanopharm.co.uk