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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)
Clinical Evaluation: Current guidelines and how it should be done? Who needs what for regulatory submissions and market access- EU, India & Global.
Aaditya Vats
Terumo India Private Limited, India
Director - Regulatory Affairs and Quality Assurance
Realistic clinical evidence for medical devices – What, When, How much?
Ashish Indani
Krishnamugdha Advance ResearchTeck, India
Managing Director
Panel Discussion: Clinical Evidence beyond Regulatory Requirements
Ashok Kumar Thakkar
Meril Life Sciences Pvt Ltd, India
VP & Head of Clinical Research
Panel Discussion: Clinical Evidence beyond Regulatory Requirements
Ashish Indani
Krishnamugdha Advance ResearchTeck, India
Managing Director