Category: On-Demand Webinar

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

The cloud version of Phoenix, Phoenix Hosted, 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. It contributes to reduce the total cost of … Continued

The development of new drugs for rare diseases is a challenging process due to small patient populations and the high cost of clinical trials. One key challenge is identifying optimal dosing regimens. Pharmacokinetics of drugs can vary widely between individuals, and it can be difficult to obtain enough data from clinical trials to make informed decisions about dosing. … 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

In a sector where both competition and stakeholder expectations are high, a comprehensive approach that blends digital stakeholder engagement with effective value communication is crucial for success. This presentation offers a 360-degree view on leveraging digital technologies to revolutionize how pharma companies interact with key stakeholders such as payers, providers, and patients. Simultaneously, the session … Continued

Comparing your drug and the competition in terms of efficacy and safety data in the targeted therapeutic area is critically essential for optimizing development strategies and maximizing the value of a new drug. Model-based meta-analysis (MBMA) with clinical outcome database of publications and external information has been utilized to optimize trial design in recent years. … Continued

SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies as per FDA guidance and the needs and trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort. The quality control process is critically … Continued

Discover Simcyp Biopharmaceutics, our latest addition to the Simcyp suite of technologies. This software empowers drug formulation scientists with advanced model-informed formulation development (MIFD) technology. As a proud member of the Simcyp family, Simcyp Biopharmaceutics provides a robust workbench for formulation development and optimization, maintaining the Simcyp gold standard for unparalleled formulation success. Join us … Continued

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