Accelerating Post-approval Change Management with ICH Q12 and Modern Technologies

An FDAnews FREE Webinar • Sponsored by Veeva Systems and Axendia Inc.
Thursday, April 18, 2019 • 12:00 p.m. - 1:00 p.m. EDT

Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.

Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:

  • What is ICH Q12 and potential benefits
  • Best practices and approaches to key PACM challenges
  • Approaches to manage ‘established conditions’
  • How technology can support ICH Q12 and simplify change management
  • Innovative ways leading pharma companies are addressing PACM

Who Will Benefit

  • VP/Director of Quality and Compliance (QA or QC), Quality Systems
  • VP/Director of Information Technology, Quality Management Systems, Quality Systems
  • VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
  • Document/Records Managers/ Directors
  • Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
  • IT System Administrators
  • Quality Training Coordinator

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Meet Your Presenters

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Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis, Founder and President, Axendia. Dan’s firm specializes in advising regulated life science and healthcare firms on business, technology and regulatory matters. With 25+ years of experience focusing on the health sciences value chain, he has extensive leadership experience in areas including technology, regulatory compliance, and business. His background includes a B.S. in electrical engineering and an M.S. in technology-focused management.

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Mike Jovanis

VP-Vault Quality, Veeva Systems

Mike Jovanis, VP-Vault Quality, Veeva Systems. As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.