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Course Agenda
​
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

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