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Bethesda North Marriott Hotel and Conference Center

2024 年 02 月 12 日 8:00 上午 - 2024 年 02 月 14 日 2:30 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 10 Track 4: Electronic Product Information (ePI): A Digital Passport for Therapeutic Product Information

Session Chair(s)

Jo  English

Jo English

VP and General Manager, Enterprise Technology

Calyx, United Kingdom

This session will provide a holistic view of electronic Product Information (ePI), emphasizing its significance in delivering timely drug information to patients and healthcare providers. You’ll gain insights into the current status of ePI adoption and discover the essential factors needed for its global implementation.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the purpose of ePI & how it fits within regulatory ecosystem
  • Highlight the current state of ePI adoption globally
  • Describe the benefits of adopting ePI, best practices for implementation, and barriers to adoption
  • Explain how ePI interacts with global data standard initiatives & Why it matters

Speaker(s)

Katja  Pecjak, MPharm

Electronic Product Information (ePI): A Digital Passport for Therapeutic Product Information; case study : "Unlocking ePI: A Possible Solution to Drug Shortage Management"

Katja Pecjak, MPharm

Billev Pharma East Ltd., Slovenia

Director BD, Sales and Marketing

G. Scott  Gordon, PhD

Electronic Product Information (ePI): A Digital Passport for Therapeutic Product Information

G. Scott Gordon, PhD

FDA, United States

Senior Health Informatics Officer, OSP, CDER

Cesar  Vinces

Speaker

Cesar Vinces

Accumulus Synergy, United States

EU Interim and International Policy Lead

Hilmar  Hamann, PhD

Speaker

Hilmar Hamann, PhD

European Medicines Agency, Netherlands

Head of Information Management

Niklas  Jaenich, PhD, RPh

Speaker

Niklas Jaenich, PhD, RPh

Boehringer Ingelheim, Germany

Head of Global Labeling Operations and Digitization

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