Sponsored Webcast: Achieve Regulatory and Commercial Success for Your First Biopharma Product

18 November 2015
12:00-1:30pm ET

Whether this is your first product launch or just the latest of many, obtaining timely FDA approval and considering key commercialization factors early in the development cycle are imperative to the continued success of your business. This webcast will help you navigate the complex US regulatory approval process for new molecular entities and understand the roles of regulatory, clinical, nonclinical and CMC stakeholders, including a discussion of the success factors for appropriate FDA interactions.

You will learn key considerations for outsourcing aspects of product development and regulatory approval. Topics covered also will include critical labeling decisions and other commercial considerations for product success, such as licensing, channel and distribution strategies and reimbursement.

Learning Levels: Intermediate & Advanced

Learning Objectives:
Upon the webcast's conclusion, you will be able to: 

• Understand the most critical aspects of development for a new molecular entity
• Efficiently communicate and interact with FDA to help reduce development timelines
• Identify the right regulatory outsourcing partner for your product development program

Who Should Attend?

• Pharmaceutical, biotechnology and medical device companies
• Companies with a product in any phase of the development continuum as well as approved products
• Small companies starting development for their first biopharmaceutical product