Mohammed Abdul Jawad

7 months ago · 1 min. reading time · visibility 0 ·

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Outlook 2020: Best Practices for Regulatory Success

Outlook 2020: Best Practices for Regulatory Success


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Outlook 2020: Best practices for regulatory success

As Pharmaceutical companies expand the number of regions within which clinical, manufacturing and marketing authorization is performed, the demands for managing regulatory change intensifies.


Coupled with the growing diversity in product make-up (biologics, cell and gene therapies, companion diagnostics, delivery devices, digital health), the depth and breadth of regulatory changes can cripple Quality and Regulatory functions.


The process of managing regulatory change is

  • Burdensome,
  • Costly, and
  • Prone to compliance risk.


The task of changing SOPs to comply with regulatory change in multiple global regions is anything but simple, and industry leaders look to change the paradigm completely.


Although regulatory functions have not widely applied artificial intelligence to streamline and automate processes, AI and digital automation have the potential to support and transform this business need. Ultimately, this will allow pharmaceutical companies to react to changes in regulatory requirements in a nimble and highly efficient manner, to reduce compliance missteps and avoid risks and fines.


In this presentation, we discuss a new approach that leverages technology, AI and automation to streamline SOP monitoring and updating and increase efficiencies. After this webinar you’ll be able to:
  • Understand current challenges to tracking and integrating of SOPs into your internal systems to successfully and efficiently maintain compliance
  • Understand a best practice approach on leveraging regulatory intelligence, technology and AI to drive a simultaneous submission process
  • Evaluate your internal systems for better implementation of AI in your regulatory processes
  • Identify critical success factors and barriers to adoption


Presenters

CHRISTOPHER MUNDY

Director, Solutions Consulting

Clarivate Analytics




ELIZABETH HOLLOWAY
Sr. Regulatory Solutions Consultant
Clarivate Analytics







Source: Clarivate

                                                                                                     * ~ * ~ *

About Clarivate:  Clarivate is a global leader in providing solutions to accelerate the lifecycle of innovation. Its bold mission is to help customers solve some of the world’s most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. Clarivate helps customers discover, protect and commercialize their inventions using their trusted subscription and technology-based solutions coupled with deep domain expertise. For more information, please visit clarivate.com

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