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Webinar: Avoiding Delays to the Clinic

A checklist to help bring your drug product to the clinic on time

Manufacturing issues can delay drug approvals and complicate the relationship between drug firms and their contract suppliers. Following an FDA post, it was established that in 2016 the primary deficiency of several new drug applications was a failure to comply with the FDA’s current Good Manufacturing Practice (cGMPs) regulations that were designed to control product quality. 

 

In this webinar we help you prepare for clinical manufacturing by identifying the major reasons why projects get delayed and ways to avoid them. Dr David Brett will provide tactical insights on this issue including, establishing a plan to choose primary packaging and materials, how to prepare legal documents, and guidelines for choosing a development and manufacturing partner that can offer the quality necessary for filing for approval on time.

Participation in this webinar will help you attain a practical ‘road map’ that can help shorten time to clinic while maintaining high product quality, safety and efficacy.

Key Learning Objectives

  • Planning steps characteristic in clinical manufacturing
  • Creating a plan to choose the right packaging and materials
  • Getting the legal aspects right the first time
  • Choosing a high-quality CDMO for clinical and scale up manufacturing

Join our webinar on Nov 15

3PM London / 10AM New York / 4PM Berlin



 

Date Nov 15, 2017
Location Online
Speaker Dr David Brett, Product & Service-Manager
Presentation Avoiding Delays to the Clinic
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