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Good Clinical Practice and Pharmacovigilance Issue Management and CAPA Effectiveness
Session Chair(s)
Federico Feldstein, JD
Vice President, Global Head of R&D Quality Compliance
Johnson & Johnson, United States
Opportunities exist in establishing effective processes for oversight of good clinical practice/pharmacovigilance significant deviations and Corrective and Preventative Actions effectiveness. This session presents regulatory and industry perspectives, best practices, and emerging trends related to issue management.
Learning Objective : Discuss the evolving regulatory environment and applicable requirements for the management and disclosure of significant deviations/issue management of GCP and pharmacovigilance; Share key inputs to an effective Corrective and Preventative Actions (CAPA) management system, including outputs that support sustainable CAPAs; Identify critical escalation pathways, including communication across applicable stakeholders and disclosure to regulators.
Speaker(s)
Misconduct and Management of Serious or Persistent Noncompliance: Recognizing, Managing and Proactively Mitigating
Denise Ruby
Takeda Development Center Americas, Inc, United States
Director, Clinical Compound Support Quality Assurance
FDA Perspective
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
FDA Perspective
Namita Kothary, PharmD, RAC
FDA, United States
Consumer Safety Officer
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