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D2.S6: Clinical Evaluation for Medical Devices
Session Chair(s)
Priyadarshini Arambam
Director, Clicebo Solutions Pvt Ltd, India
Session Overview: Clinical Evaluation is a critical area of medical devices. Not only the regulators, but other stakeholders such as reimbursement authorities, insurers and payers also ask for the clinical evidence. It is indeed the most critical aspect for the clinicians to get the confidence and reason for use of medical devices. However, with the changing landscape of regulation, clinical practices and their synergies, the clinical evidence also has significant adoptions. This session focuses on these synergies and adoptions.
Speaker(s)
Aaditya Vats
Director - Regulatory Affairs and Quality Assurance, Terumo India Private Limited, India
Clinical Evaluation: Current guidelines and how it should be done? Who needs what for regulatory submissions and market access- EU, India & Global.
Ashish Indani
Managing Director, Krishnamugdha Advance ResearchTeck, India
Realistic clinical evidence for medical devices – What, When, How much?
Ashok Kumar Thakkar
VP & Head of Clinical Research, Meril Life Sciences Pvt Ltd, India
Panel Discussion: Clinical Evidence beyond Regulatory Requirements
Ashish Indani
Managing Director, Krishnamugdha Advance ResearchTeck, India
Panel Discussion: Clinical Evidence beyond Regulatory Requirements
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