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Tuesday, June 18 • 8:00am - 9:00am
#205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-560-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Hilmar Hamann, PhD

Facilitator
Cesar Vinces

Facilitator
Vanni Carapetian, MPH

Facilitator
Heiner Oberkampf, PhD


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
avatar for Vanni Carapetian

Vanni Carapetian

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
avatar for Sridevi Nagarajan

Sridevi Nagarajan

Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom
Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors... Read More →
avatar for Heiner Oberkampf

Heiner Oberkampf

CEO, ACCURIDS, Germany
Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has... Read More →
avatar for Norman Schmuff

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States
Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives... Read More →
avatar for Cesar Vinces

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States
Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Workshop