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Tuesday, June 20 • 10:30am - 11:45am
#208: Big Data: Regulatory Information

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will explain leveraging information assets to show correlations and relationships and discuss effective management of regulatory information. This forum will cover all aspects of big data, RWD/RWE, etc.. as it pertains to the regulatory environment. From data standards to analytics, the forum will explore the potential benefits and challenges from a regulatory perspective.

Learning Objectives

Discuss effective management of regulatory information.

Chair

Vada A. Perkins, BSN, MS, MSc, RN

Speaker

FDA Perspective
David Martin, MD, MPH

Health Canada Perspective
Vikesh Srivastava

Panelist
Thomas Senderovitz, DrMed, MD



Moderators
avatar for Vada Perkins

Vada Perkins

Identifica, LLC, Identifica, LLC
Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards t... Read More →

Speakers
avatar for David Martin

David Martin

Liaison to the Reagan-Udall Foundation IMEDS Program, OMP, CDER, FDA
David Martin is involved in opening Sentinel resources to the public, developing real world evidence policy, and engaging patients in evidence generation. He is the principal investigator for the first effort to capture patient-provided data through a mobile device application, s... Read More →
avatar for Vada Perkins

Vada Perkins

Identifica, LLC, Identifica, LLC
Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards t... Read More →
TS

Thomas Senderovitz

Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at t... Read More →
VS

Vikesh Srivastava

Associate Director, Business Informatics Division, HPFB, Health Canada
Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa... Read More →


Tuesday June 20, 2017 10:30am - 11:45am
N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616