Facing Inactive Ingredient Database Challenges? Navigating the Complexity for Successful Regulatory Filings

Oct 02, 2018

Register Free: http://www.pharmtech.com/pt_w/IID

The Inactive Ingredient Database (IID) provides information on inactive ingredients present in FDA-approved drug products and is used by industry as an aid in developing drug products.

How can sponsors gain a better understanding of the FDA requirements and avoid lengthy review cycles, unnecessary requests for additional safety studies/information, and Refuse-to-Receive (RTR) letters from the agency?

In this webcast, leading global regulatory experts Dave Schoneker from Colorcon and Priscilla Zawislak from Dow Dupont come together under the Controlled Release Alliance to share their insight and describe how to use the IID to make good formulation decisions, overcome regulatory hurdles, and get to market faster.

 

Key Learning Objectives:

  • Understand the current status of the IID and the FDA requirements
  • Unlock the IID challenges that may impact your filing and make better formulation decisions
  • Learn how to access and utilize tools in support of your bridging justification for a smooth submission process.

 

Who Should Attend:

  • Pharmaceutical formulation and product development scientists, regulatory managers, and project managers 

 

Speakers:

David R. Schoneker, Director of Global Regulatory Affairs, Colorcon Inc.

Priscilla S. Zawislak, Global Regulatory Affairs Advocacy Manager, Dow DuPont

 

Date and Time:

Live: Tuesday, 2 October, 2018 at 11 am EDT | 10 am CDT | 1600 BST | 1700 CEST

After the final airing of the webcast on 2 October, 2018 it will be available on demand until 2 October, 2019. 

Sponsor: Colorcon Inc. and Dow DuPont

Register Free: http://www.pharmtech.com/pt_w/IID

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