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Course Agenda
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11.00 AM – 12.00 PM: How Does the Pandemic Compare to Other Types of Crises 
in the Medical Product Industry

• Historical overview of FDA regulations for Crisis Events
• Type of crises: Internal and External Events, Technological, Regulatory and Organizational
• Anticipated, Potential and Rare Unpredicted Events
• Specific issues for FDA related industry
• Impact of FDA decisions on regulatory decisions in Rest of the World​

12:00 PM – 1:30 PM: Emergency Use Authorizations (EUA) for Various Products
Determining eligibility and applying for EUA for:

• The pre-EUA process
• Diagnostics for a new disease
• Drugs: new, repurposed and off-label use of approved drugs
• Biologics: Vaccines, antibody and cellular therapies
• Special release of products by FDA

  
1:30 – 2.00 PM: Break

2:00 PM– 3:00 PM: Meeting/Contacting FDA in a Crisis Situation  

• Emergency meetings/conference calls with the FDA
• Medical Countermeasures procedures
• FDA’s timeline for responding to queries during a crisis
• The post-submission interactions with the FDA
• Special communication protocols

 

3:00 – 4:30 PM: Disaster Management, Recovery and Business Continuity SOPs

• Prioritizing operations, personnel safety, and regulatory compliance
• Process for creation and approval of disaster management policies
• Grading scale for the risk of shutdown of operation
• Communication plans for special situations 
• Business continuity verses Patient safety

 
4:30 – 4.45 PM: Break

4:45 PM – 6:00 PM: Clinical Trials, Product Distribution and Compliance During Crisis

• Short-term interruption of ongoing clinical trials
• Planning activities for new clinical trials
• Protocol amendments to address the crisis
• Remote monitoring, digital data collection, and distance patient reported outcomes
• Supply Chain management
• Maintaining compliance with reduced staff and operations