Medical Officer, CDER US Food and Drug Administration
Obtaining a new product approval quickly is one of the most critical factors shaping the pharmaceutical industry’s performance. Getting a new drug through the FDA approval process on the first attempt is likely to be worth millions of dollars in additional revenue. Companies hoping to speed their drug candidate to market fear the impact that a delay would have on their bottom line. This is where a robust regulatory strategy can make all the difference! We invite you to participate in an interactive session that covers how to develop and successfully implement a regulatory strategy. We will take a deep dive into appropriate steps to take to avoid disastrous mistakes. You will work with your colleagues to analyze different scenarios. Then you can compare your answers with a panel of industry leaders, who will provide practical advice on how to avoid potential pitfalls. Hopefully, you will be inspired to develop a new regulatory strategy or improve upon your existing regulatory strategy.
Describe key factors to consider when developing a global regulatory strategy.
Recognize dangerous pitfalls in the development of global regulatory strategies.