Risk-Based Strategies to Prevent Drug Shortages - Webinar CD/Transcript
Risk-Based Strategies To Prevent Drug Shortages: PDA’s New TR 68 Guidance on Manufacturing and Quality Issues
Drug shortages, especially for the supply of critical medicines, have emerged as an issue that affects patients worldwide and has drawn the attention of international regulators.
In February, the Parenteral Drug Association (PDA) released Technical Report 68 (TR 68): Risk-Based Approach for Prevention and Management of Drug Shortages, which describes a risk-based model — at a product level — to identify drug shortage risks due to manufacturing and quality issues. Plus, it establishes a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan — a holistic framework which includes simple templates.
Get an inside look at TR 68 from Emma Ramnarine of Roche Pharma, one of the report’s authors, and Susan Schniepp, a 30-year industry veteran who has held numerous positions in the PDA.
TR 68 has been reviewed by FDA, EMA and other regulatory agencies and has quickly gained acceptance as globally significant in the effort to reduce drug shortages.
In this presentation, Ms. Schniepp and Ms. Ramnarine will teach you the 4 most important ways to immediately stem shortages, including:
- How to apply a proactive risk-based model at a product level to identify drug shortage risks due to manufacturing and quality issues
- Best practices to write and enforce the kind of plans prescribed in TR 68 using examples and standard templates
- Conducting internal audits to determine if your current controls are properly designed to address drug shortage risks — and if not, what your next move is
- They’ll challenge you to think creatively and in a risk-based manner about other practical ideas that can be leveraged beyond conventional solutions. Tips include:
- Collaboration with health authorities to expedite post-approval changes
- Short-term use of an alternate facility
- Activating short-term supply from alternate sources during emergencies