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Collaboration Beats Compromise in Combination Product Development
Combination product design and development, and the decision making surrounding these processes, is complex. Early collaborations between CDMOs and their manufacturing partners is an effective means of managing this complexity. However, the best collaborations seek to develop a common understanding of program risks, technical risks, decision-making processes, who decision-makers are, a common language for the design and development, and a common vision for the program. These collaborations work to identify potential commercial manufacturing risks, and then address them during product development, to reduce overall risk during product launch. This effort maximizes the opportunity to successfully and efficiently manufacture combination products that are compliant with FDA 21 CFR, or other relevant regulatory standards, including 210/211 for drug handling. We will explore an effective collaborative model for combination design and development, and how we leverage this model to bring complex products, including combination products, to market in a timely manner, without sacrificing product quality.
11-08-2020 | Webinar | A morning | | Entry: Free (after registration)
Assessment of Potential Drug-Drug Interactions from In Vitro Experiments to PBPK Modeling
In this webinar, attendees will learn about: Assessment of potential DDIs by in vitro studies Application of the FDA guidance to DDI study design, data interpretation and modelling Understanding of fundamental theories and development strategies of PBPK models Benefits and applications of PBPK models to preclinical drug development and design of first clinical trials
11-08-2020 | Webinar | An afternoon | | Entry: Free (after registration)
What You Need to Know: Med Device UDI Submission to China
This webinar will give an introductory presentation on NMPA current status, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, China NMPA data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions on the differences between Fda gudid and China NMPA.
13-08-2020 | Webinar | A morning | | Entry: Free (after registration)
Hit-to-Lead Optimization Strategy in Drug Discovery
In vitro biochemical assays make possible the high throughput screening (HTS) of large compound libraries. A successful HTS campaign is typically viewed as one that identifies large numbers of diverse chemical series hits as potential starting points on the way to a clinical candidate. These hits are typically weakly active in a primary screen and do not necessarily possess drug like characteristics. Hit-to-Lead optimization is now a key process in drug discovery that explores the chemistry and biology of hits to focus efforts on the most promising starting points so that development time and costs are saved. What makes a promising starting point for a drug discovery program? In this webinar, strategies to triage hits and focus efforts will be discussed.
13-08-2020 | Webinar | A morning | | Entry: Free (after registration)
eSource: A Piece of the Virtual Trial Puzzle
eSource has long been touted as the solution to high data management and monitoring costs and inefficiencies. This webinar will cover the history of eSource, the reasons it did not take off as quickly as people initially expected, and where eSource is headed. From EMR/EHR to wearables, to site source, the industry is moving towards capturing data electronically for clinical trials and then repurposing it for downstream analysis, at a far higher volume than usual due to COVID-19. eSource has the potential to change the antiquated process of capturing data during a clinical trial. The effect on the efficiency of monitoring, site and data management processes is significant. Join this webinar to hear first-hand how one CRO leveraged eSource to lower overall costs for sites, data management and monitoring. This webinar will provide a grounding in what eSource is, how it can be deployed, the practical implementation of eSource and how to avoid hurdles in the process.
18-08-2020 | Webinar | A morning | | Entry: Free (after registration)
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