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#274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-605-L04-P; CME 1.00; RN 1.00

The pharmaceutical industry faces challenges due to global regulations. Structured data and cloud platforms can facilitate global collaborations. Visualizing the control strategy can enhance understanding of patient benefit-risk.

Learning Objectives

Recognize how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Discuss the concepts of IDMP and PQ/CMC and their roles in product quality discussions; Illustrate how an overall control strategy supports efficient product quality communication.

Chair

Ciby Joseph Abraham, PhD

Speaker

Panelist
Katie Duncan, PhD

Panelist
David Sidney Ross, MBA, MSc, PMP, RAC

Panelist
Vada Perkins, DrSc, MSc

Panelist
Omar Serang


Speakers
avatar for Ciby Abraham

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →
KD

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States
Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
avatar for Omar Serang

Omar Serang

Chief Cloud Officer, DNAnexus, United States
General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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