This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program.

Supported by several case studies, this webinar will demonstrate how the 505(b)(2) regulatory pathway can be leveraged to maximize the value of your drug asset by taking a closer look at several key factors such as:
  • Reliance (e.g. – Listed Drug, Literature)
  • Study Design
  • Differentiation (e.g. - Target Product Profile (TPP), Labeling)

Featured Speaker

Kenneth V. Phelps

President
Camargo Pharmaceutical Services

Ken Phelps is co-founder and President of Camargo. He has over 40 years of industry experience, including a number of executive-level positions in areas such as quality control, project management and regulatory, clinical and medical affairs.

Date:  Thursday, February 21, 2019
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar