Innovations in Value Communication: Optimizing Payer Engagement at the Local Level in Rare Disease, Oncology, and Gene Therapy

September 14, 2021 – 11:00 am ET Securing reimbursement from national payers is critical to your product’s commercial success. However, payers at the local and regional levels continue to get more authority to manage their own budgets. This makes engaging with payers and designing an effective strategy for value communication difficult as the concept of … Continued

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

Tue, Aug 10, 2021, 11:00 AM – 12:00 PM EST The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs.Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of modeling & simulation software for regulatory … Continued

Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval

In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued

Plain Language Summaries & Patient Engagement in Pediatrics

Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health. Patient engagement is key to supporting PLS development. Factoring patient insights and experience into PLS development drives improvement of PLS quality, readability, and comprehension. … Continued

Upcoming 2021 Certara University Express Webinars

Certara University is pleased to announce our complimentary 30-minute Express webinar series: Simplify Your Submission Review Process With an Anywhere, Anytime eCTD Viewer Date/Time: Tuesday, August 24, 2021 at 11:00AM EST Description: Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency … Continued

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