march, 2019

25marallday27alldayFDA Boot Camp 2019New York, NY, USA

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Event Details

10% off with code D10-874-874AX01

This premier event is designed to provide professionals working in the life sciences space with a strong working knowledge of core FDA competencies.

In addition to providing a “101” training, our updated agenda offers advanced guidance sessions discussing the pathways to approval, a patent and IP overview for pharmaceuticals, post-approval issues, and recalls and withdrawals. In addition, each step of the process comes with strategies to apply this knowledge to real-life situations.

Experts at this event will help you:

  • COMPREHEND the structure of FDA
  • GAIN a practical working knowledge of clinical trial process for pharmaceutical products
  • MASTER the basics of the application and approval processes for drugs, as well as follow-on products such as ANDA’s and Biosimilars
  • RECOGNIZE the pivotal role of labeling, as well as promotions and off-label communications in drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • UNDERSTAND the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

Register by January 18, 2019 for best rates plus save an extra 10% off with code D10-874-874AX01

Time

march 25 (Monday) - 27 (Wednesday)

Location

Park Lane Hotel New York

36 Central Park S, New York, NY 10019

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