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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Shakul Hameed
Director, Global Regulatory Affairs Operations at Horizon Therapeutics Austria GmbH


Shakul is a seasoned Regulatory Operations/Regulatory Information Management (RIM) professional with over 16 years of experience in the pharmaceutical and contract research organization (CRO) industries. He is currently working at Horizon Therapeutics Austria GmbH, where he leads the Regulatory System, Regulatory Data management and governance as well as the EU & International submissions functions. His previous experience includes regulatory operations/RIM positions at BeiGene, Novartis, Baxter, Baxalta, Shire, Takeda, and PRA. Shakul's expertise includes developing and implementing global strategies for the management of regulatory systems, data, and documents, business process optimization, global submission publishing and delivery, submission standards & intelligence, as well as the potential future state of regulatory digitalization, such as artificial intelligence, automation, etc.

Agenda Sessions

  • EMA CTIS and Sponsor RIM Systems: Managing Data Flow and Business Process for Clinical Trail Applications (CTA)