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Monday, June 17 • 3:30pm - 4:30pm
#147: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-546-L04-P; CME 1.00; RN 1.00

Join industry leaders in this interactive forum to discuss the development of ICH initiatives ICH Q12 and ICH M4Q(r2), how they will impact the product approval lifecycle, and the technology that will manage these processes and the data.

Learning Objectives

Describe important initiatives that will have a direct impact on the pharmaceutical product approval lifecycle; Identify how the initiatives will influence changes in our industry for patient-product access and faster approvals; Discuss how technology and data has a major role in bringing these initiatives to reality.

Chair

Brooke Casselberry, MS, RAC

Speaker

Panelist
Andrew Chang, PhD

Panelist
Ciby Joseph Abraham, PhD

Panelist
Alexander Gaffney, MS, RAC

Panelist
Lawrence Yu, PhD


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 →
avatar for Brooke Casselberry

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States
Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Alexander Gaffney

Alexander Gaffney

Executive Director, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States
Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs... Read More →
avatar for Lawrence Yu

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Forum