The FDA 505 (b) (2) Drug Approval Process

Reduce cost and timelines by using Strategy, Commercial and Regulatory aspects
מרצה: Mr Ken Phelps

תאריך: 7 נובמבר 2012
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 12609
שפת הקורס: אנגלית
על הקורס

The era of the blockbuster drug is over; companies are facing the patent cliff. Pipelines are drying up and jobs are being cut. In order to thrive, you must lower development risk, reduce cost and increase speed-to-market.

The US FDA’s 505(b)(2) approval pathway lets companies modify and reposition existing drugs to provide improved safety and efficacy for marketing clearance. However, before you can determine if it’s a fit for you, you must understand how it works. First, you need to understand its unique regulatory requirements, then the best process to approach the FDA with your 505(b)(2) development plan.  

Discover how to navigate the intricate 505(b)(2) process. Through recent case studies, Camargo Pharmaceitucal Services President and CEO, Ken Phelps will illustrate the variety of global development programs available under 505(b)(2). While this process lends itself to FDA approval in North America, Phelps will discuss the benefits for international companies to develop products utilizing this pathway.

קהל היעד

First Part : Regulatory, QA Clinica,CSOl and R&D personnel
Second Part: C-Level Executives, Business Development, Strategy and Venture Capital

The FDA 505 (b) (2) Drug Approval Process
התועלת שתופק

The participants will learn the principles of knowing which products have verified profit potential before development begins and what helps to defend their value to investors and reduces the risk of costly marketing errors.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

First Part

  • The regulatory differences between 505(b)(1), 505(b)(2) and 505(j) submissions
  • The risks and benefits of each type of submission
  • The drug development process requirements of a 505(b)(2) submission

Second Part

  • The costs savings and shortened timelines of a 505(b)(2) submission
  • Current candidates for 505(b)(2) submissions
  • Global drug development and approval using 505(b)(2)
אודות המרצה

Mr Ken Phelps

Ken Phelps relied on more than three decades of experience in the health science and services industry to found Camargo Pharmaceutical Services in 2003. As an expert in end-to-end drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps and his team attain two to five pre-IND meetings before the FDA per month. Aiding companies across more than 26 countries, Camargo provides successful FDA approval of numerous drug products each year.

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