Webinar
Future of Regulatory Publishing – including eCTD 4.0
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June 7, 2023

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11:00am - 12:00pm

(GMT-04:00)

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Join our upcoming webinar, Future of Regulatory Publishing – including eCTD 4.0, to gain a comprehensive understanding of the benefits, differences, implementation statuses, and considerations surrounding eCTD 4.0. Our experts will walk you through the entire process and make sure that you are ready for this upcoming milestone.

Speakers:

Sadia Ahmed

Product Manager, Regulatory Technology

Sadia Ahmed is Product Manager – Regulatory Technology, leading the team responsible for RIM Smart Submission Management at IQVIA. She has over 20 years of experience in IT and Life Sciences Industry working globally for consulting and technology solution companies. Her expertise includes comprehensive knowledge of global electronic submissions publishing, business process optimization, document management, systems integrations, and regulatory information management. Sadia holds Bachelor’s degree in Computer Science from Rutgers University.

Jasbir Chohan

Executive Vice President at Framework Solutions (formerly ONIX Life Sciences)

Jas spent 20+ years in regulatory operations within the pharmaceutical industry. Most notably she founded and served as CEO of ONIX Life Sciences, a company that provided eCTD submission outsourcing services to clients globally. She successfully grew ONIX from inception into being a recognised industry leader successfully serving a wide variety of clients and across application types. Jas has a deep global understanding of the Regulatory Operations/eCTD submissions, the ever-changing regulatory operations requirements and particularly the challenges faced by clients in drug applications to regulatory health authorities. She has a strong track record of delivering success across every submission her and her team have managed for 10+ years, which in turn has allowed her to build strong and trusted long-term relationships with her clients and peers.

Parikshith Shanthappa

Associate Director Regulatory Affairs, Publishing Center of Excellence
Parikshith Shanthappa, Associate Director Regulatory Affairs Publishing Center of Excellence takes care and contribute to IQVIA Submission Management services. He has over 13 years of experience in Submission strategy, planning and Submission management publishing. He has done Master of Science with specialization in Molecular Biology. He has an extensive experience in publishing & filling various types of regulatory submissions. he is also automated few publishing process to save huge amount of time and efforts. He is expert in migrating submission date from one system to another compilation system.

AMAR TANDON

Associate Director Regulatory Affairs, Publishing Center of Excellence
Amar Tandon, Associate Director Regulatory Affairs Publishing Center of Excellence takes care and contribute to IQVIA Submission Management services. He has over 15 years of experience in Submission strategy, planning and Submission management publishing. A certified Project manager holding double post-graduation in Master of Business administration with pharmaceutical marketing and Master of Science in Clinical Research and Regulatory Affairs. His expertise includes comprehensive knowledge of global end to end electronic publishing services, operational excellence in regulatory operations, Submission management and planning ,business process optimization and regulatory information management.

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