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Publishing has long been a core competency of Regulatory Operations and has evolved in many ways since paper publishing was first introduced. Advanced Regulatory processes that utilize electronic publishing and digitization enable operations to work more efficiently and provide greater value to organizations.

While we’ve come a long way as an industry, there are even more innovative technologies on the rise with the adoption of new eCTD and data standards. Automation and AI are at the forefront of new Regulatory technologies, and will shape the way we report to global Health Authorities in the future. Organizations must now stay abreast of changing technologies, compatibilities, and integrations in addition to shifting regulations and guidance.

In this webinar participants will build a better understanding of:

    The modern Regulatory Operations process

    Current and future technologies to support adoption of new publishing standards
    How outsourcing plays a role and the vendor selection process
    Identifying pitfalls early on and mitigating barriers

Learn how to help your organization through the next generation of regulatory publishing challenges and drive greater efficiencies using technology and outsourcing.


Speakers:

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Michelle Gyzen

Senior Director, Integrated Global Compliance

IQVIA


As Senior Director, Americas and Asia Pacific, Integrated Global Compliance, Michelle Gyzen is responsible for designing technology and services solutions for safety, regulatory and quality compliance. She has over 16 years of experience in pharmaceuticals, biotech, and medical devices as both an industry expert and consultant to the industry. Michelle has authored and contributed to publications highlighting the future of Regulatory technology and services and has particular expertise in designing large scale regulatory programs. Prior to IQVIA, Michelle served as Global Head of Life Sciences Business Process Services for a leading outsourcing company providing services in regulatory consulting, safety, biostats, and process development to many of the top 20 pharma companies. Her previous experience also includes positions in Regulatory Affairs and Operations for a top pharma company as well as biotech startup organization. Michelle studied at both North Carolina State University and Southern New Hampshire University.

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Rama Mohan Rao Chikkam

Senior Director, Global Regulatory Affairs

IQVIA


As Senior Director of Global Regulatory Affairs in Asia Pacific, Chikkam is responsible for managing the region’s Global Regulatory Operations and Regulatory Affairs technology enhancement support. He has over 27 years of experience in the pharmaceuticals, CROs and IT industries. Prior to IQVIA, Chikkam served as Global Head of Regulatory Operations and Regulatory Business Partner managing Regulatory Outsourcing / Offshoring activities such as Regulatory Submissions, Electronic and Paper Publishing, Labelling Artwork Design, Regulatory Information Management, RA Life Sciences Technology supporting Submission Compliance, Labelling Compliance and Market Compliance. His previous experience also includes positions in Regulatory Affairs and Operations for a top pharma European company, as well as other generic pharma organizations.


Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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