Plain language regulatory requirements have recently come into effect for the EU and UK. This webcast will provide an overview of both the regulations and guidance around plain language summaries (PLS) and other documents. The webcast will also look at the “why” behind plain language regulations and how they can be used for patient engagement … Continued
The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and pharmaceutical industries, shifting responsibility for drug costs away from beneficiaries and onto plans and manufacturers. The law affects provider reimbursement, changes AMP and ASP calculations, and, perhaps most significantly, allows the federal government to negotiate prices for the first time—all … Continued
Scientific and strategic consulting includes a broad range of activities, and the many consulting firms and clients often define these practices very differently. One way to categorize the activities is in terms of the professional’s area of expertise (such as modeling and simulation, clinical and medical development, as well as clinical pharmacology). But in practice, … Continued
Are you struggling to effectively communicate the value of your products or services in today’s competitive market? Join our exclusive webinar, where we dive into the critical role of value communication in determining your commercial success. In this session, we will explore how the right approach to value communication can be a game-changer for your … Continued
New versions of D360 are released twice a year to reflect and include customers’ functionality requirements. Recently, our users utilized D360 for a variety of modalities, so we have been providing new and improved functionality for amino acid and nucleic acid sequence manipulation. D360 is also integrated with Certara’s AI solutions to provide seamless access … Continued
The Standard for Exchange of Nonclinical Data (SEND), which standardizes nonclinical data in a consistent structured format, was developed to enable rapid review of electronic nonclinical data for regulatory submissions. It has been required by FDA CDER as a requirement for electronic submissions since 2016 and by FDA CBER since 2023. Certara’s SEND Explorer is … Continued
What is model-informed drug development (MIDD), and why is it so critical to informing the development of safer and more effective new drugs? During this event, you will uncover ways to leverage model-informed drug development (MIDD) to maximize the value of your data. You will also learn how to successfully extrapolate beyond your observed data—so … Continued
PK/PD data comes from multiple sources, making it challenging to efficiently search, visualize, and analyze your data, and remain compliant for regulatory submissions. Especially with the large volumes of PK/PD data required for today’s complex clinical trials. With Certara’s Integral data and model repository, you’ll streamline your PK/PD workflows and ensure compliance with regulatory requirements … Continued
Certara’s Phoenix Hosted package provides your PK scientists with a secured and validated Certara AWS workspace allowing for much quicker transit time from compliant data sources. It enhances productivity and supports compliance requirements by managing complex time-based data, the foundation for all PK/PD modeling. Certara’s deployment experts can optimize the Phoenix application configuration for increased … Continued
In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many … Continued
