Author: webdev
Certara Broadens and Increases Regulatory Strength with Two Executive Hires
PRINCETON, N.J.—May 21, 2020 — New executives bring strategic and cross-disciplinary expertise to navigate changing regulatory environments
COVID-19 Therapeutic Considerations for Children and Pregnant Women
Watch this webinar to learn about tools & processes to help tailor COVID-19 therapies for special populations, including children and pregnant women
Certara & DMTC Collaborate to Study Using Chloroquine in Healthcare Workers at Risk for COVID-19
Certara applying expertise in clinical pharmacology, innovation and collaboration to accelerate potential prophylaxis for COVID-19
Certara Launches New Version of Simcyp® Simulator for Population-Based Pharmacokinetic Modeling and Simulation
Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
Regulatory and Medical Writing
High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.
Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19
COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now. Speakers: Demetrius Carter, SVP … Continued
Certara Launches COVID-19 Pharmacology Online Resource Center
Funded by the Bill & Melinda Gates Foundation, the online Center helps accelerate therapeutics for COVID-19 by integrating clinical pharmacology, innovation and collaboration
FDA Approval of Oral Testosterone Replacement Enabled by Phoenix NLME & Trial Simulator
Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
Accelerating Therapeutics for COVID-19
This webinar will explain lessons learned from preparing for and responding to viral outbreaks such as H5N1 and pH1N1 influenza and discuss how insights from model-informed drug development approaches can spur access to medicines for patients.