Category: 온디맨드 웨비나

Master clinical phase transitions with insights from industry leaders! Join Piet van der Graaf, SVP and Head of QSP, Hugo Geerts, Head of Neuroscience Modeling QSP, Mirjam Trame, VP of Certara Drug Development Solutions, and Julie M. Bullock, PharmD, SVP of Drug Development Services at Certara. We are thrilled to welcome keynote speaker and panelist … Continued

Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of targets in order to try to predict off-target interactions leading to safety issues in humans. To date, this has generally required an opinion-based approach, but opinions vary and are inherently unreliable. To evaluate this quantitatively requires the use of surrogate … Continued

Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery Refine your approach to early drug development with insights from industry experts in our upcoming webinar, “First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling (PBPK).” If you’re seeking strategies to identify and advance your small molecule drug candidates, expedite product profiling, formulation, … Continued

Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued

Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued

While the popularity of tools like ChatGPT have brought AI to the forefront of tech investments, nearly 73% of life science companies still struggle to adopt an appropriate AI technology. Some of the biggest challenges to successful adoption are clearly defined use cases, appropriately trained AI that understands scientific concepts and approachable applications for leveraging … Continued

Traditionally, PK Scientists have operated with locally installed applications to resume their PK analysis. In this environment the computer system was under control of the local IT department who would provide all necessary documentation expected by regulatory authorities to provide evidence that their computer system is CFR part 11 compliant. In the new world of … Continued

As the drug development industry strives to accelerate submission timelines and improve patient access to healthcare solutions, regulatory professionals are increasingly pressured to leverage technology to go faster. During this webinar, Heather Graham, vice president of regulatory science and medical affairs at Certara, will facilitate a panel comprising industry experts to discuss the current technology … Continued