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WHITEPAPER

Pharmacovigilance Compliance- Changing Regulatory Landscape during pandemic

 

The onset of the COVID 19 pandemic had a severe impact on the healthcare system, regulatory compliance management, and socio-economic environment across the globe. Automation in business transformation, risk management, and signal detection of new drugs for increased efficiency and compliance with regulatory requirements will be the key success criteria for a robust pharmacovigilance process.

This whitepaper deals with the impact of covid across various countries, governments, and organizations involved in PV regulatory sectors and how TEDREG- a Tata Elxsi regulatory intelligence tool can help health authorities reduce manual effort at various levels.

Read this whitepaper to understand:

  • How can a business continuity plan(BCP), technology, inspection, and regulatory intelligence help tackle PV Quality Management Systems (QMS)?
  • What are the five key differences between pharmacovigilance of small molecules and Advanced therapy medicinal products?
  • How can TEDREG help reduce 90% of your manual effort to search for regulatory information and perform impact analysis?

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