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The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency.

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you understand what is involved in an NDA including regulatory strategy,

In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. This webinar will review Commissioner Gottlieb’s statement,

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will share tips on regulatory strategy,

Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial?

Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this webinar, Dr. Shoemaker and Dr. Kesler

The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product

Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study.

This webinar will review the content of both the Target Product Profile (TPP) and the Integrated Product Development Plan (IPDP), demonstrate how they are written, and provide specific examples of decisions that

Pursuing big pharma dreams on a small budget? This webinar will discuss product development strategies for small biotechnology and pharmaceutical companies.