Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategies - Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 23+ years’ experience focused on implementation of Risk Minimization Programs , Quality Management Systems and Pharmacovigilance Compliance for companies within the pharmaceutical industry.In his current role as a Director, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Affairs Clinical at Amneal Pharmaceuticals, he manages all REMS activities for multiple programs including operations and development of new programs and ensures the entity’s full compliance with the regulatory requirement and risk management standards and guidelines.
Sessions
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Tuesday - November 23, 2021 - 15:20
Fireside Chat: Strengthening Risk Evaluation and Mitigation Strategies (REMS)
- Creating a REMS Industry-Wide Standardized Risk Evaluation and Mitigation Strategy (REMS) Program
- Global regulatory developments
- EU GVP XVI revision – what we could expect?
- REMS for generics
- Effective tools and strategies to improve REMS effectiveness
- REMS at the patient-level: improving safety and proper use of medicines
- Evolving REMS: New opportunities for branded drugs
- What have we learned? Next steps toward the future
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