eCTD Submission Challenges

Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges. This webinar will identify current eCTD submission challenges, provide applicable solutions and take a look ahead at what’s to come.

Learn how to save valuable time on PK/PD analysis and modeling with Certara’s Phoenix Platform

Performing individual and population PK/PD analyses requires knowledge and experience with multiple tools to meet desired analysis outcomes within a timely manner. Certara’s Phoenix Platform provides access to the most sophisticated PK/PD workbench tools available today enabling greater ease of use and more efficient pharmacometric workflows, and offers features that support compliance and efficiency.  In … Continued

Learn how to streamline PK/PD workflows with Certara’s Integral Data Repository

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

Ask Me Anything: Career Opportunities in Regulatory & Medical Writing

Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). Our team is growing, and we’re looking for people with … Continued

Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use.  During this webinar, we present a framework for qualification of the Simcyp Simulator … Continued

Smarter Clinical Document Automation for Transparency and Disclosure Requirements

Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly but are often overwhelmed with the “who’s and “how’s of the cumbersome and costly efforts to meet these requests. With time working against … Continued

Learn how Certara’s Integral streamlines PK/PD workflows & ensures compliance with regulatory requirements

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

Learn why Phoenix is the industry gold standard for PK/PD analysis

Performing individual and population PK/PD analyses requires knowledge and experience with multiple tools to meet desired analysis outcomes within a timely manner. With Certara’s Phoenix Platform, you can provide your scientists the tools they need to efficiently perform PK/PD modeling and simulation to support your drug research and development. During this webinar, we’ll be discussing … Continued

Medical Writing Software that Automates Data and Your Workflow Processes

Certara’s Synchrogenix™ Writer is a purpose-built writing software for the Pharmaceutical industry that encompasses automation, organization, and collaboration to generate your regulatory submission documents. The software is designed to minimize complexity, help accelerate timelines, and enhance management of large scale medical writing initiatives. Certara understands the effort and complexity that goes into the authoring of … Continued

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