Jason Michaelides, O.D. Email and Phone Number

Set the quality vision and strategy and drive quality and compliance across the Vision Care and Pharmaceutical R&D organizations to ensure on-going compliance with regulations, Health Authorities expectations and Alcon / Novartis polices and standards. Proactively identify and address areas of potential compliance issues and monitor the overall status of quality and compliance within Vision Care and Pharmaceutical R&D franchises. Ensure that adequate key quality and performance indicators are defined and implemented, and adequate action plans defined and implemented. Ensure R&D franchises are in a state of inspection readiness for regulatory inspections and group audits. • Oversight of Global Clinical Manufacturing, Supply and Distribution • Chair Procedural Review Board governing all R&D level SOPs and processes • Oversight of the R&D supplier/vendor qualification process• Collaborate with Manufacturing Technical Operations on Technology Transfer from Development• Provide QA review and endorsement for all Vision Care and Pharmaceutical regulatory submissions• Provide compliance guidance and oversight to Analytical Chemistry / Stability department activities, including shelf life protocols and reports for regulatory filings

Direct the Medical Information department in the management of all non-order related incoming communications, including IOL calculations and contact lens consultations involving all marketed Alcon products (~18 reports) and the global Clinical Applications department providing clinical training for WaveLight products (~ 20 reports). Develop the infrastructure to provide timely, accurate and compliant medical information in response to requests for on and off label information relating to all Alcon marketed products to internal and external customers. • Hire, train, and manage MIS personnel to triage incoming communications for adverse events and product complaints, and process requests for on- and off-label information• Provide quality assurance review to ensure accurate, timely and compliant responses• Development and management of the process for providing IOL power calculations to Alcon surgeons• Development of metrics and generation of reports and trend analysis• Represent MIS on new product and product upgrade launch teams• Assure that the processes and medical information provided are compliant with applicable medical, legal, regulatory, and commercial standards and guidelines.• System owner and administrator of MIS Database, Information Request Management System (IRMS)• Provide clinical and technical support to Phase IV activities to ensure compliance and alignment with marketing messages • Liaison between Global Medical Affairs and Medical Safety, including member of Signaling Committee • Provide medical assessment of reported adverse events for Medical Safety • Management of global clinical training operations for WaveLight products• Indirect management of Regional Medical Information personnel • Provide clinical and technical expertise to Legal department

Direct the Clinical Affairs department (~10 reports) in development and management of the infrastructure to conduct U.S. and international clinical trials to support regulatory approvals or clinical applications of Alcon refractive surgical devices. Primary accountabilities include:• Direct and coordinate clinical trials to be conducted by qualified medical doctors in the U.S. and abroad. • Negotiate and manage contracts with clinical investigators and sites, contract research organization (CRO), and consultants. • Supervise compliance to SOPs, work instructions, GCP and regulations by clinical research scientists, CRO, and clinical sites. • Analyze and evaluate clinical data for accuracy and content.• Supervise and participate in preparation of regulatory submissions, presentation and publication materials • Provide clinical, technical and regulatory expertise to other departments within Alcon in the development of new products, clinical education materials, marketing materials, risk documents and management of customer or field-related issues.• Critically review and summarize clinical complaint files for Technical Consumer Affairs and Legal departments.• Prepare for and participate in audits of OTC facility from regulatory agencies.• Develop clinical evaluation plan and report for all released projects and participate in validation testing for the release of new products and product upgrades.