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Session 7, Track A: Connecting PACs, Sustainability, and Cloud Solutions for Effective Life Cycle Management
Session Chair(s)
Susan Koepke, MBA
Head of Regulatory Affairs LATAM
EMD Serono, Inc., United States
Flavia Firmino Ribeiro, PharmD
Regulatory Policy Lead - Latin America
Eli Lilly and Company, Brazil
This session will highlight the recent accomplishments of the ICMRA PQKM Collaborative Pilots, illustrating how the collaborative assessment process pilot has the potential to evolve into a global regulatory programme. Regulatory authorities will share experiences as full participants or observers on the collaborative pilots.
Additionally, the session will highlight the significance of sustainability in Pharmaceutical Lifecycle Management by examining the evolution of electronic product information practices.
Learning Objective : At the conclusion of this session, participants should be able to:- Analyze ICMRA PQKM Pilot results and their impact on global collaborative assessment processes
- Apply insights gained from regulatory authorities to enhance future collaborative initiatives
- Recognize sustainability in Pharma Lifecycle Management and the shift to electronic product information and its industry impact
Speaker(s)
Connecting PACs, Sustainability, and Cloud Solutions for Effective Life Cycle Management
Brenda Gomes Valente, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Regulation Specialist
ePI in Focus: Rethinking the Life Cycle Management of Labeling
María Lineth Perez Rodriguez, PharmD, MSc
Pfizer, Costa Rica
Labeling Team Lead
ICMRA Collaborative Assessment Pilot – Roche’s Experience
Erika Hannibal, RPh
Roche International Ltd, Uruguay
Senior Regulatory Group Director, PTR, International Regulatory
Connecting PACs, Sustainability, and Cloud Solutions for Effective Life Cycle Management: Swissmedic Perspective
Gabriela Zenhaeusern, PhD
Swissmedic, Switzerland
Head Stakeholder Engagement