Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices

Medical device is a 1 trillion US dollars market all over the world. Though we have essentially segregated the “clinical trial requiring devices from other devices, the clinical trials requiring devices are the major contributors to the economics of the medical devices.

The medical device industry in India has witnessed tremendous growth in recent years and one of the key challenges is evaluation of medical devices by scientific sound clinical trials. Regulatory bodies of different countries have tried separating the medical device related clinical trials activities from the regulation of drugs. However, a lot of evolution is still due. Newer guidelines of Schedule Y  Medical Devices, CDISC & DCASH, and GHTF etc. are indicative of another great diversity upcoming in this area.

There are many questions for which one constantly seeks answers, like:

• Why is this change required
• How does clinical research practice of medical devices differ from the one for drugs, cosmetics and neutraceuticals
• What are the aspects of critical difference between medical device clinical trials and others
• How should we implement our medical device quality systems
• What is the role of pharmacovigilance in medical device clinical trials

Currently the clinical research practices in most cases of intend to retrofit medical devices into the practices and methods applicable for the drugs research. Through this conference we intend to bring all stakeholders Viz. Manufacturers, Contract Research Organizations, Academia, Scientific & Medical Fraternity and policy makers together to seek answers to the above raised and many more questions.

If you wish to get these answers from the industry experts, join us for one day Conference – Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices”

Who should attend

• Clinical Research and regulatory affairs professionals
• Research and development professionals from the medical device manufacturing industry
• Statisticians, medical writers and clinical operations personnel, QA personnel , COOs and CEOs of the Contract Research organizations, who undertake or intend to undertake a medical device study
• Research fellows in medical device research, clinical research and biotechnology students who intend to work in the medical device clinical research
• Consultants, legal and clinical advisors in medical devices
• Doctors , investigators, co-investigators, research coordinators who intend to conduct clinical research in their institutes with medical devices
• Regulatory persons, device inspectors and clinical research officers at various governing bodies
• Insurance companies, claims and policy underwrites

Our esteemed faculty for the Conference and Workshop include:

Ashish Indani,Head of Clinical Research,Meri lLife Sciences

• Ashok Thakkar, Senior Manager Clinical Research and Medical Writing, Sahajanand Medical Technologies Private Limited
• C.L. Kaul, former Director, NIPER, Mohali
• S. Raisuddin, Head, Centre for Translational & Clinical Research, Jamia Hamdard
• Khalid Khan, Director, Fermish Clinical Technologies Pvt Ltd.
• Akarsh Verma Independent Consultanting Medical Device clinical Research
• Imran Lohani, Sr.Manager ClinicalResearch, Meril Life Sciences
• Vivek Malhotra, Head Regulatory Affairs/QA, Samsung
• Sundeep Agarwal, GM Compliance & Regulatory Affairs, Datt Medi products Pvt. Ltd.
• Bhupesh Kohli, Stryker India
• Kirti Arora, Head Regulatory Affairs – Boston Scientific India
• Sandeep Arora, Medical Director Terumo
• Ashish Aggarwal, Senior Statistical Programmer at Cytel Statistical Software & Services Pvt. Ltd
• Jayesh Jani, Medical Director, Boston Scientific
• Sundeep Mishra, Professor in Cardiology, All India Institute of Medical Sciences
• Priyadarshini Arambam, Head of Clinical Research, Fortis hospitals and research Centre
• Punita Sharma, Director, Integris Healthcare/Translumina
• Sumati Randeo, Director Global Strategy, Regulatory Affairs & Advocacy Abbott Laboratories
• Anish Desai, Director, Medical Affairs, Clinical Operations and Medical safety at Johnson and Jonson
• PV. Mohanan, PhD, Scientist-F& Head, Toxicology Division, Sree Chitra Tirunal Institute for Medical Sciences and Technology

Click here to download Conference Agenda

Click here to download Registration Form

Please feel free to call us in case of queries. Our Contact Details are:

Ms. Siddhi Parab: +91 22 69000660, [email protected],
Mr. Nishant Singh: 09540930950, [email protected]

Regards
Manoj Karwa
Head-Clinical Operations
Auriga Research Ltd

Association of Indian Medical Device Industry (AIMED) as Supportive Partner for the Event