Join us for an insightful event delving into the Target Product Profile (TPP) that helps you set the path for drug product development and supports business decision making. Gain insight on how to determine your CMC development strategy based on this TPP, and apply Quality...
Join us for an insightful discussion on ensuring quality every step of the way in your product or service journey. From inception to market, understanding Critical to Quality (CTQ) factors is paramount. We'll delve into the intricacies of research and development, navigating GxP and IT...
Toxys & Venn Life Sciences share their insights on the possibilities for use of alternative methods in drug development. Our previous webinar on challenges in Non-Clinical Drug Develpment was met with enthusiastic reception and sparked numerous inquiries on alternative, highlighting the community's keen interest and...
Pharmacokinetics (PK) is generally referred to as ‘what the body does to the drug’ versus ‘what the drug does to the body’ (pharmacodynamics ). Pharmacokinetics describes the fate, or time course, of an administered drug within the body. The physiological processes that determine the time course of the drug are Absorption, Distribution, Metabolism and Elimination (ADME).
Discover the crucial role of translational science and how laboratory findings are transformed into patient treatments. This session emphasises strategic decisions necessary for successful drug development and discuss case studies where initial failures led to unexpected opportunities. Gain practical insights from a real-world case study...
The estimand framework a crucial step in defining the question of interest, needing interdisciplinary collaboration for valid inference. In this webinar, we will clarify the concept of estimands, the different types of intercurrent events and how to handle them, using examples. Emphasis will be placed on the importance...
Transitioning from preclinical to clinical development is a critical step in drug development, often accompanied by significant challenges. This webinar will explore key considerations from a clinical pharmacology perspective, and explore potential solutions to establish a robust plan for your First-In-Human study. Speaker: Tom Habraken...
Join the first webinar of our series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 16 January 2025. In this webinar, we will be covering the general aspects; giving you a brief introduction into regulatory affairs and the documentation required...
Join our second webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 6 February 2025. Following our first webinar on general aspects on Thursday 16 January 2025, this webinar will delve deeper into the various documents required...
