In this insightful webinar, originally presented at Pharmapack Europe 2022, S. Ross Tsakas, Pharmaceutical Segment Leader at Sterigenics, delves into the intricate process of parenteral drug development. Parenteral drugs and their development lifecycles embody significant complexities, often spanning multiple years and requiring multi-million-dollar investments. Drawing on over 90 years of experience supporting the pharmaceutical, biotech, and medical device industries, Sterigenics has identified five key hurdles that must be overcome: sterility, quality control, compliance, regulatory affairs, and routine manufacturing.
Ross will explore each of these challenges in a systematic, concise, yet compelling manner, providing valuable insights and practical strategies for addressing them. As sterilization increasingly becomes a top priority for clients across the entire supply chain, the importance of robust sterilization processes cannot be overstated. This webinar aims to equip participants with the knowledge and tools needed to navigate these complexities effectively.
Key topics include:
- Sterility: Understanding the critical importance of maintaining sterility throughout the drug development process and the latest advancements in sterilization techniques.
- Quality Control: Implementing rigorous quality control measures to ensure the safety and efficacy of parenteral drugs.
- Compliance: Navigating the complex regulatory landscape to achieve and maintain compliance with global standards.
- Regulatory Affairs: Managing the regulatory requirements and submissions necessary for bringing parenteral drugs to market.
- Routine Manufacturing: Overcoming challenges in the routine manufacturing of parenteral drugs to ensure consistent product quality and supply.
As Sterigenics continues to support global health initiatives, this webinar highlights their strategic support efforts designed to expedite products to market while ensuring their safety. Participants will gain a comprehensive understanding of the parenteral drug development process and learn how to tackle the key challenges that arise.
Join us to enhance your expertise in parenteral drug development and learn how to effectively manage the complexities associated with bringing these critical drugs to market.