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Session 2: Study Design Considerations & Safety Monitoring of Medical Devices during Clinical Trials
Session Chair(s)
Jhonas B. Aguinaldo
Regional Safety Officer - Asia Pacific, Medical Device Safety
Johnson & Johnson International (Singapore) PTE. LTD., Singapore
Session 2: Study Design Considerations & Safety Monitoring of Medical Devices during Clinical Trials
Speaker(s)
Distinguishing Aspects of Safety Surveillance of Medical Devices
Jhonas B. Aguinaldo
Johnson & Johnson International (Singapore) PTE. LTD., Singapore
Regional Safety Officer - Asia Pacific, Medical Device Safety
Complexities & pragmatic approaches to Causality Assessment in Medical Device cases
Ashish Indani
Stryker , India
Sr. Manager – Clinical Affairs
Indian Regulations related to Medical Devices & update on the Materio Vigilance Program of India (MvPI)
Shatrunajay Shukla
Indian Pharmacopoeia Commission, India
Scientific Assistant MvPI
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