Dr. S. Eswara Reddy
Drugs Controller General (India),
Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare, Govt. of India

Dr. H.G. Koshia
Commissioner, FDCA, Gujarat State
Food & Drugs Control Administration
Gandhinagar, Gujarat

Dr. Arvind Kukrety
Deputy Drugs Controller
Central Drugs Standard Control Organisation Zonal Office, Ahmedabad

Shri Rajiv Nath , Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) and Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad

Shri Kishore Khanna, Managing Director, Romsons Group of Industries, Agra

Dr Jitendar Sharma MD & CEO , AMTZ & Advisor, Health & Med. Tech., Govt. of A.P., Visakhapatanam*

Shri Suranjan Gupta
Executive Director, Engg. Export Promotion Council, Delhi

Mr. Prakash Bachani
Scientist 'E" & Head (MHD)
Bureau Of Indian Standards

Mr. Anupam Gupta
Advisor
Quality Council of India

Dr. T S Kumaravel Founder Chairman , GLR Laboratories Pvt. Ltd., Chennai

Dr. S S Murugan, MSc, PhD ,
Managing Director , GLR Laboratories Pvt. Ltd., Chennai

K. R. Navaneetha krishnan M.Sc (PhD)
Asst. Director , GLR Lab. Pvt. Ltd., Chennai

Dr. Atul Sardana Director, Alfa Corpuscles Pvt. Ltd., New Delhi

Mr. Ketan Vadodaria
Head Incharge - Medical Textiles
The South India Textile Research Association

Mr. Hiten Bheda
President,
The All India Plastic Manufacturers' Association (AIPMA) &
Managing Director
Vinit Performance Polymers Pvt Ltd.

Dr. Prashant Jha - Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India

Shri N.K. Balgi Director, Milacron India Private Limited, Ahmedabad

Dr Ramanan
Chief Technology Officer
Sahajanand Medical Technologies

Mr. Ganesh Sabat
CEO
Sahajanand Medical Technologies Pvt. Ltd.

Mr. Sanjay Shah CEO, Unikal Consultants, Ahmedabad

Dr. Chirag Patel
Assistant Professor, Microbiology
Shree Krishna Hospital Karamsad

Mr. Masayuki Sakai Regional Industry Lead, Healthcare APAC,

INEOS Styrolution APAC Pte Ltd.

Dr. Alok Ray

Executive Director

Stanford-Indian Biodesign

Dr. T S Kumaravel Founder Chairman GLR Laboratories Pvt. Ltd., Chennai	Dr. S S Murugan, MSc, PhD Managing Director GLR Laboratories Pvt. Ltd., Chennai	K. R. Navaneethakrishnan M.Sc (PhD) Assistant Director GLR Laboratories Pvt. Ltd., Chennai

GLR Laboratories is a leading provider of biocompatibility solutions and testing. The regulatory standard for biocompatibility (ISO10093) is rapidly changing and regulatory agencies are scrutinizing biocompatibility studies in greater details than ever before. The notion of biocompatibility as a box ticking exercise has changed to that of custom designed studies addressing a particular device or device family. There is more emphasis on proper selection of test sub systems, extract preparation, overall safety assessments. In this session, we will critically analyse these recent changes to ISO10993 standards and how they will affect the medical device manufacturers. Specifically, we will discuss indetailthe upcoming version of ISO10993, Part 1; Chemical and Physical Characterization; FDA’s views on biocompatibility; controversial topics like combining component of a kit in single study and biocompatibility outsourcing. As usual, we will provide case studies and hands on experience on these critical changes so that the manufacturers are ready to face this upcoming regulatory change. Also, if you want any specific topics to be discussed, please email us on navanee@glrlabs.com / dlpandya@gmail.com

1. Workshop On Recent Changes To Biocompatibility Testing Manufacturers’ Perspective

2. Workshop on Manufacturing of Orthopedic Implants : Materials, Design, Regulations On Patient

3. Medical Device Manufacturing : Critical Issues

4. Medical Plastics : Materials, Processes & Markets – Emerging Trends

5. Panel Discussions