Notified Body Requirements for Drug-Device Combinations: Demystifying Article 117 The involvement of a notified body is an essential aspect of the regulatory process for combination products covered by Article 117, as it helps to ensure that the device component of your combination product is safe,...
Join us on June 27, 2023, at Kadans Plus Ultra Leiden for an exclusive, hands-on workshop: Roadmap To Early Clinical Entry: The Devil Is In The Detail. Brought to you by Venn Life Sciences, part of hVIVO plc, Centre for Human Drug Research and Batavia...
Speaker: Ion Tcacencu – is an ATMP expert with over 17 years of experience as scientist within regenerative medicine and immunology, being responsible for projects developing new ATMPs. Ready to explore the cutting-edge world of Advanced Therapy Medicinal Products (ATMPs)? Don't miss our exclusive webinar where we delve...
Join the Cutting-Edge Conversation Are you ready to embark on an extraordinary exploration of Advanced Therapy Medicinal Products (ATMPs)? Get ready to immerse yourself in the dynamic world of ATMPs development and manufacturing, led by none other than Ion Tcacencu, an esteemed ATMP expert with...
FREE SPONSORED WEBINAR - This webinar will cover the impact to defined Product Performance Specifications and User Needs, including the necessary updates to the drug dossier and technical documentation for inclusion in the submission packages. Changes are required to approved drug products as part of the lifecycle. To...
Learn from Venn experts who have helped dozens of innovators like you develop the right plan that helped them get funding and approval. Sign up now to our Kickstart Workshop on building a Drug Development Plan: Don’t do too much but do it right Join...
Join our upcoming webinar, designed to untangle the intricacies of non-clinical challenges in drug development. It's imperative to recognize that beyond the clinical aspect, there exists a complex domain of non-clinical considerations that greatly influence the trajectory of drug development. These considerations range from understanding...
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...
