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Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence
Session Chair(s)
Terrance Ocheltree, PHD, RPH
VP, Head of Regulatory Affairs and Quality Assurance
Corium, Inc., United States
This workshop will feature regulatory and industry experts highlighting efforts by World Health Organization (WHO), International Coalition of Medicines Regulatory Agencies (ICMRA) and other organizations to drive mutual recognition, work sharing, and regulatory collaboration and harmonization. After the short presentations, participants will divide into small groups to discuss ways to advance some of these efforts and identify opportunities for regulatory authority and industry engagement.
Learning Objective : Discuss ways to advance harmonization and identify opportunities for regulatory authority and industry engagement.
Speaker(s)
Facilitator
Mic McGoldrick, MT
MSD, United States
CMC Technical Advocacy and Policy
Facilitator
Tânia Teixeira, PHARMD
European Medicines Agency, United States
EMA Official at the FDA