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Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies
Session Chair(s)
Joseph Scheeren, PHARMD
Founder
Scheeren HealthCare LLC, United States
Several global and regional collaboration initiatives are in place in order to foster access to medicines, specifically for patients in developing countries. The main objectives of these initiatives are to accelerate approval processes based on regulatory collaboration and reliance. As an example, supported by the World Health Organisation (WHO), National Medicines Regulatory Authorities (NMRAs) can inform their own assessment report process by drawing on the assessment performed by a reference authority, so called Stringent Regulatory Authority (SRA). Based on selected case studies, this session will examine collaboration initiatives and review the opportunities and challenges from authority and industry perspective.
Learning Objective : Discuss the complexity of regulatory convergence; Identify the progress being made through case studies.
Speaker(s)
Regulatory Collaboration Initiatives in Order to Accelerate Approval Process in Developing Countries
Petra Doerr, PHARMD, RPH
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Director
Collaborative Registration Procedure: A Tool to Accelerate Regulatory Approvals - Case Studies from Africa
Mercè Caturla Goñi
Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium
Global Access Regulatory Leader, Regulatory Policy (Africa and WHO)
A Novel Tool to Support Optimized Regulatory Strategies for Emerging Markets: A Case Study
Rajneesh Taneja, PHD, RPH
TB Alliance, United States
Senior Director, Pharmaceutical Product Development