San Francisco Bay Area Chapter Webcast: Managing Drug Shortages and Managing CMC Challenges for Biologics

1.0
RAC Credits
Wednesday, 27 January 2021 (9:00 AM) - Wednesday, 27 January 2021 (10:00 AM) Pacific Time (US & Canada)

Members: $10 (USD)
Non-members: $25 (USD)

Description

 Anyone working in biotech knows the often-immense challenges our industry faces with drug shortages. In 2019, FDA’s inter-agency Drug Shortages Task Force published a report entitled, Drug Shortages: Root Causes and Potential Solutions. The number of drug shortages has been increasing, lasting longer, and been a persistent healthcare problem despite efforts to prevent and mitigate these issues. The impact on patients of these shortages is substantial. Understanding the regulatory leader’s role in managing these crises may help prevent and mitigate the impact of drug shortages. A Global Regulatory Lead from Jazz Pharmaceuticals will share his experiences, challenges faced with drug shortages, and recommendations from a regulatory perspective.  

A separate challenge that the biotech industry often faces is manufacturing issues for biologics that traditionally do not arise when manufacturing small molecules. Understanding the CMC regulations for biologics and the regulatory leader’s role in addressing these manufacturing challenges are important aspects of drug development. A Global Regulatory CMC Lead from Jazz Pharmaceuticals will describe her experiences with complying with the CMC Regulations for biotech products compared to those for small molecules. 

The webcast will conclude with a Q&A session. 

This event is brought to you by the RAPS San Francisco Bay Area chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.

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 Speakers:
Jonas Wilf, director, global regulatory lead, Global Regulatory Strategy,
Jazz Pharmaceuticals, Inc.
Vijaya Kuppa, senior manager, Global CMC Regulatory Strategy,
Jazz Pharmaceuticals, Inc.