Indiana Chapter Webcast: The Trials and Tribulations of Handling Older Regulatory Applications

RAC Credits
Monday, 17 August 2020 (12:00 PM) - Monday, 17 August 2020 (1:00 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


Dealing with Module 3 regulatory updates and changes to applications that can be decades old is challenging and difficult. This session will discuss using a risk-based approach to handle regulatory application revisions in consideration with regulatory guidance and trends and industry-standard changes in the last 25 years. The presentation will cover various suggestions and options to bring the clinical trial or commercial application up to date to meet current standards. 

The webcast will discuss the following topics: 

  • When less is more (i.e., ELA and PLA to a BLA) and when more is better (e.g., critical process controls, additional USP testing, etc.).
  • The importance of due diligence when reviewing the application before receiving it. Licensure, transfer, and purchase are subject for consideration.  
  • With a focus on the initial application, which may have been approved decades ago, changes along with the supplements throughout the product life cycle. 
  • How to handle unavailable documentation (i.e., documents lost in a warehouse; paper copies; buried in annual reports and never included in the Quality section of the application; beyond the level of detail required but is now considered a commitment and analytical tests either in-process; or a release that was added but did not address the quality of the drug substance/drug product). 
  • How to handle the application once it is in your control.
  • How to assure that the manufacturer of the drug substance and drug product meets all regulatory commitments filed with all Competent Authorities.

Learning objectives of this webcast include:

  • Participants will be able to determine a regulatory strategy for managing clinical and commercial Module 3 applications that may not have met current regulatory guidance and industry standards.
  • Participants will be able to discuss how Regulators will be made aware of gaps in the applications and how they will be managed.

This event is brought to you by the RAPS Indiana Chapter  to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Jerry Chapman, senior GMP quality expert, Govzilla
Mark Slisz, senior regulatory advisor, Pearl Pathways