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Previous Conference Speakers
Dr. S. Eswara
Reddy Dr. S. Eswara Reddy is working as Drugs Controller General (India). He is the youngest Drugs controller General (I) who has worked for all the positions of the hierarchies. Dr. Reddy was born in 1969 in the state of Andhra Pradesh, India. He completed his Masters Degree in Pharmacy from College of Pharmaceuticals Sciences, Manipal in 1994 and Ph.D from J.N.T.U, Hyderabad in 2009. He is having vast experience in manufacturing of pharmaceuticals, academic and in the drug regulations. Dr. Reddy started his career in 1998 as a Drugs Inspector at CDSCO, West Zone, Mumbai. At CDSCO, Mumbai he has conducted GMP, GCP and GLP audits. He promoted as Assistant Drugs Controller of India in 2009 and appointed as Deputy Drugs Controller (India) in 2012. In 2014, he was appointed as Joint Drugs Controller (India). Dr. Reddy is very industrious and has a very positive attitude towards his work. His generous nature makes him a great leader. He has participated in many national and international seminars/workshops/meetings on various areas of Drugs regulations and undergone training from USFDA, KFDA, PMDA and WHO, Geneva. He was awarded with “Best Drugs Inspector award” in 2005 and “Distinguished Alumni Award” from Manipal Academy of Higher Education, Manipal. Dr. Reddy had rendered presentations in various national and international seminars and workshops. His diligence has got him appreciation letters from his superiors for effective implementation of Drug Regulations. He has also published articles in various journals. Recently, he received “Best Drugs Control Officer” award in the year 2016 during 66th IPC held at Hyderabad. With the vision to promote public health he was actively involved in framing of Medical devices Rules 2017, 12th Five Year Plan for strengthening of Indian Drugs Regulatory System and international matters related to MOU, SOI, and other quality issues. He has organized various trainings for CDSCO officials to enhance their knowledge and make them even more competent. He has also conducted Risk Based Inspections to ensure the quality of drugs being marketed in the country. At CDSCO, Dr. S Eswara Reddy headed various internal divisions like medical device, biological, new drugs, import & registration and others. He works with a great enthusiasm and always committed to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
Mr.
Rajneesh Tingal Shri Rajneesh Tingal holds Bachelor of Engineering (Mechanical) degree from Delhi College of Engineering and MS in Tropical Technology from Institute of Tropical Technology, University of Cologne, Germany. He also possesses degree if Law (LlB) from Delhi University and has pursued Advanced Certificate in Public Administration from Maxwell School of Public Administration, Syracuse University, USA. Before joining government service he has worked for more than five years with M/s BHEL and has experience in design, production and commissioning of power equipment. He has held various portfolios and important assignments at the Central Government level in the Ministry of Agriculture & Cooperation, Ministry of Home Affairs and Cabinet Secretariat. He has also experience in local administration with an extensive stint with New Delhi Municipal Council (NDMC). Shri Tingal is working in his present assignment as Joint Secretary in the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers since 1st November, 2016 and is responsible for the National Institutes of Pharmaceutical Education & Research (NIPERs), Public Sector Undertakings (PSUs) and Medical Devices sector.
Shri H.G.
Koshia Dr. H.G. Koshia, Commissioner, Food & Drugs Control Administration, Gujarat. His Key Responsibilities are Enforcement of “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Safety & Standard Act, 2006” and rules, in Gujarat State. He is actively representing nine national and state level committees. He is Chairman of the very important committee “Track & Trace”, for preparation of guidelines to prevent of menace of spurious drugs. Dr. Koshia regularly interact with officials of US FDA, Health Canada, MHRA, DCGI, technocrats, academicians, IDMA, Chemists & Druggists Association etc. to ensure a consultative approach towards inclusive development and growth. He has played a pivotal role in transformation of pharma sector in Gujarat to emerge as a favorable investment destination with proactive & pragmatic approaches. He has played a vital role in the implementation of e-governance in FDCA and is winner of one state level and three national level awards.
Dr. Arvind
Kukrety - Deputy Drugs Controller Arvind Kukrety is working as Deputy Drugs Controller India in Central Drugs Standard Control Organisation, Ahmedabad Zone since 2015. He is M. Pharm from Jamia Hamdard University, Delhi. He has got about 24 years of working experience in the field of manufacturing of drugs, Quality Assurance and drug regulation. He started his carrier from M/s Winthrop (now known as Win-Medicare) in production supervisor and left the organization as Assistant Manager technical before joining CDSCO in 1998. During his stint in Industry, he worked in various capacities in the manufacturing of oral, external and parenteral dosage forms. In 2003, during WHO GMP workshop he was assessed as the best among the participants and was selected thereafter for various WHO assignments. As short term consultant for WHO he was part of NRA assessment teams for Indonesia & Thailand. As facilitator, he participated in WHO GMP workshops for inspectors of Indonesia and China. In 2005, Ministry identified him as GMP expert for assessment of vaccine manufacturing PSU. He was trained as trainer in GMP and GCP and was associated in various workshops for training of inspectors in India. He also represented in Govt. of India missions in South Korea and Suriname. In CDSCO HQ he worked in new drugs, Biological, import and export, Global clinical trial divisions. He was exposed to dossier assessment procedures of biological in 2008 in Canada. He has played a major role in preparation of Guidance documents for Biological and similar biologic guidelines. In 2011, he led the first team from CDSCO for inspection of foreign manufacturing sites in China. He is actively involved in framing of risk based inspection policy and their evaluation.
Shri Rajiv
Nath Mr. Rajiv Nath is Jt. Managing Director of Hindustan Syringes & Medical Devices Ltd. which is having a turnover of over 500 Crores & Trustee – Safe Point India – a CSR Initiative of HMD (Hindustan Syringes & Medical Devices Ltd.). He is President of All India Syringes & Needles Mfg. Association. (AISNMA) & as well as the Founder and Forum Coordinator – Association of Indian Medical Device Industry (AIMED) with over 350 Members nationwide whereby Medical Device Manufacturers all types of technologies have been attracted nationwide on one Platform. He was born in 1962 and entered his family business. He has widely travelled all over World to over 52 Countries and has attended various meetings of WHO/ UNICEF/ ICASA/SIGN. As Forum Coordinator of AIMED, Mr. Nath has taken many initiatives of establishing a Collaborative Framework with various Dept. of the Govt. and Media to bring to their attention issues troubling the industry and attract investments into India in his quest to make India as the Preferred Manufacturing Destination and the leading Supplier of Medical Device Worldwide. Position held:
An active Member of expert committee and Task Force for Medical Devices Regulation in India.
Shri Kishore Khanna Mr. Kishore Narain Khanna, the Managing Director of Romsons Group of Industries is responsible for the brand “ROMSONS”. He has an insatiable appetite for success and innovation which has led to the cultivation of the brand “Romsons” as an eminent player in the healthcare sector, serving millions of patients worldwide with quality oriented products. Today, Romsons has the largest product portfolio under its Umbrella. Romsons group has been affiliated with the Indian medical device industry for over 65 years and has seen this industry rise and shine. He started his career with various odd jobs including working long hours on manually operated moulding machines and assembly of products. After he took over the family business, he brought all kinds of technical changes, process up gradations and mastered the art of innovative manufacturing. He travelled across the globe in search of business and learned the dynamics of international business. It was then that Mr Khanna pioneered many concepts that have proven to be crucial to his success. As a result today Romsons is one of the most pre-eminent brands in the business and he wants to further make Romsons a multinational giant with its operations across the globe. Needless to mention he has a vision to change the face of Indian medical device industry and take it to a whole new level and bring it at par with the world medical device industry.
Dr Jitendar Sharma Biographical Sketch: Known in policy forums as the “Med Tech Man of India”, Dr. Jitendar Sharma is the Managing Director & CEO of Andhra Pradesh MedTech Zone (AMTZ) which is Asia’s first medical devices manufacturing city besides being the Adviser for Health to Govt. of Andhra Pradesh, India and Executive Director of Kalam Institute of Health Technology (KIHT)- a technology policy research body set up with the support of Govt. of India. He is adjunct faculty at University of Adelaide, Australia; and program Director for Health Technology Assessment (HTA) fellowships in India. He has been founder of 6 organizations and architect of Universal Health Coverage for the state of Andhra Pradesh- the first state in India with 50 million people to declare UHC. He is also the National Chairperson for Indian Bio-Medical Skill Consortium which is an active congregation of over 20 national academic institutions. Awarded among the “100 most impactful healthcare leaders” in global listing by Health & Wellness Congress, Dr. Sharma served as the Founder Head of Healthcare Technology Division and Head of Health Financing Divisions at National Health Systems Resource Centre (NHSRC) under Ministry of Health & Family Welfare, Government of India. He was also the Founder Director of WHO Collaborating Centre for Medical Devices in India. His past experience includes that as Hospital Administrator at Sri Sathya Sai Medical Institutions-one of India’s largest not for profit health organizations, as consultant to the World Bank for health financing, as Expert Consultant to the World Health Organization, Geneva and advisor to Health Technology Innovation Centre at Indian Institute of Technology (IIT). Dr. Sharma has authored seven books, twenty research papers and six compendiums on technical specifications for medical technologies besides contributing to a number of WHO reports on health technologies, health financing and Non-Communicable Diseases. He has been a key designer and coordinator for several health programs in India and teaches courses on health policy & health technology in several countries.
Suranjan Gupta Suranjan Gupta is currently associated with EEPC India as Executive Director. On behalf of EEPC India, he is actively involved in representing the voice of Indian engineering industry in various bilateral and multilateral engagement of India. He regularly provides inputs to Government of India on Exim policies, export promotion schemes and other areas related to trade. He is a part of EEPC India’s core team and has been closely associated with the organisation’s numerous promotional initiatives undertaken across the world. With over 30 years of work experience, previously he worked with leading Chambers of Commerce and Diplomatic Missions including Indian Chamber of Commerce (ICC), Kolkata, Confederation of Engineering Industry (now CII), New Delhi, the Delegation of European Commission in New Delhi and the Consulate of the United States of America in Kolkata.
Mr. Prakash
Bachani EDUCATIONAL QUALIFICATIONS : MIE (Electrical Engg.) GOLD MEDALIST, Institution of Engineers, India PRESENT POSITION : Scientist E & Head (MUBO-1), Mumbai. Bureau of Indian Standards, India EXPERIENCE : 32 years experience in Bureau of Indian Standards, the National Standards Body of India, having worked in Standard Formulation, Laboratory and Certification Activities. Presently posted as Scientist E & Head (MUBO-1), Mumbai in Bureau of Indian Standards, for Certification Marks Deptt. In Mumbai at national level. At the Technical level, he has overseen the following activities: 1. Product
Certification In conformity assessment of the products in electrotechnical area ,includes cables; conductors; energy meters; electrical accessories like switch, plugs and sockets, MCBs; electrical appliances like geysers, fans, motors, pumps, ballasts; GLS Sodium and compact fluorescent lamps; luminaries etc. INTERNATIONAL ACTIVITIES : Participated in various seminars organized in the country in the field of electrotechnical. Participated in the meetings of IEC for Rotating Machinery in China, Power Capacitors in Russia and Transformers in Japan. PAPERS Presentation : Presented several papers relating to Standardization, Certification in the field of Electrical Engg. at various seminars organized in the country.
Dr. T S Kumaravel
Dr. T S Kumaravel, MD, PhD, DABT Dr. Kumaravel is American Board certified and UK/Eurotox Registered Toxicologist with more than 25 years’ experience in industry as well as in academia. Dr. Kumaravel is an expert on biocompatibility testing of medical devices, development of testing strategy, biological safety assessment and has successfully defended biocompatibility reports with FDA and other global regulators. He also provides expert opinion on biocompatibility to several notified bodies as well as regulatory agencies. Dr. Kumaravel obtained his bachelor’s degree in medicine and surgery from Stanley Medical College, Doctoral degree in Pharmacology/Toxicology from University of Madras and finally obtained PhD in Genetic Toxicology/Cancer Genetics from MGR Medical University, Chennai. He then carried out toxicology research at Hiroshima University, Japan; National Institutes of Health, USA and Princess Margaret Hospital, Canada. Subsequently, he has worked as toxicologist with leading companies such as Unilever, Covance Laboratories and Huntingdon Life Sciences. He has extensive experience in toxicology and risk assessment, advising clients on their projects to comply with global guidelines. He has authored several confidential reports, 40 peer-reviewed publications and has 50 + conference papers to his name.
Dr. S S
Murugan, MSc, PhD , Dr. Murugan is a UK and EU Registered Toxicologist with more than 20 years experience in industry. Dr. Murugan obtained his Bachelors, Masters as well as Doctoral degree in Toxicology from University of Madras and MGR Medical University. He has worked with major contract research organizations (CRO) in India - Head of Genetic Toxicology at IIBAT, Toxicology and Quality Assurance Manager at SGS and Scientific Director at RCC India. He has extensive operational and quality assurance experiences. He has been instrumental in obtained GLP certification and has turned around the business at 2 Indian CROs. He has successfully faced several GLP, ISO17025 and FDA audits. Additionally, he has faced several national and international client audits. He was also a member of CPCSEA guidelines committee, which over sees the animal experimentation in India.
K.
R. Navaneethakrishnan M.Sc (PhD) Toxicologist with more than 19 years’ experience in toxicology and biocompatibility studies. Has worked in GLP certified Contract Research Organizations-Assistant Director, GLR Laboratories Pvt. Ltd; Toxicology Study Director, IIBAT and Quality Assurance Executive-SGS LSS. Good experience in toxicology/ biocompatibility testing of medical devices, agrochemicals and pharmaceuticals especially in vivo toxicology tests. Successful background in setting up of Quality Systems in Test Facility according to the OECD Principles of GLP and ISO 17025. Has faced several GLP and ISO 17025 audits. Additionally, has faced several national and international client audits. Done Master’s in Regulatory Affairs and pursuing PhD in Nanotoxicology. He has attended many international and national conferences. Has organized national and international workshops/ training programs related to medical devices. Adding to credits, also published scientific papers in peer reviewed international journals related to nano particles.
Dr. Atul Sardana Dr. Atul Sardana (MBBS, MS, FIAGES) is a minimal access surgeon with a knack for applying technology to conventional surgical principals which benefits patients. Dr. Atul Sardana has been working in the health care sector since 1990 starting as a social worker in one of Delhi’s large government hospital. He graduated in medicine from the University of Rajasthan in 1998 and served in the rural sector in there. He then did his masters in surgery in 2002 and has since been working extensively in minimal access surgery as a consultant surgeon in various hospitals of repute including Sir Ganga Ram Kolmet Hospital and Apollo Spectra Hospital. He has over 30 national and international clinical publication and presentations and is a honorary member of the World Association of laparoscopic Surgeons, and a member of the Indian Association of Gastrointestinal and Endoscopic Surgeons and the BIS Technical Committee on Surgical Instruments (MHD01). Dr. Atul Sardana has been invited at various forums and conferences as a key speaker on Medical Device Innovation and Medical Device Plastics and as a panelist on talk pertaining to the fund raising in the Healthcare sector with particular focus on Innovative Medical Device Companies in India. He has been on the committee for medical Devices constituted by the Principal Scientific Advisor, GOI and also as panelist on innovation ecosystem in Gujarat organized by GSBTM. He has also been invited to deliver guest lectures at IIT-Delhi on medical applications of textiles and has conducted workshops at IIT-Delhi and IIT-Bombay for FTT and SINE incubates on Medical Device Regulations. He was awarded the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons in 2007. He was actively involved in training of surgeons in the field of Advanced Solid Organ Laparoscopic Surgery, Endo stapling Principles and Techniques, and Laparoscopic Hernia Surgery at Ethicon Institute of Surgical Education, New Delhi and is a faculty for the conduct of the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons. He is also an active member of AIMED (All India Medical Device Manufactures Association). He is a certified internal auditor of quality management systems for medical device manufacturing as per ISO 13485:2003 from TUV-SUD. He is the Vice Chairman of the Indian Industries Association, a chamber of commerce and advocates policy change to encourage the development MSME sector. He served as the head of Technical operations at Biosurge Technologies, Mumbai and later was the founder chairman at Alfa Corpuscles Private Limited where he currently serves at the Head for R & D and Product Development. Alfa Corpuscles has been supported by the Technology Development Board, DBT, ICMR and GSBTM for its various efforts at developing Novel and technically advanced, low cost indigenous medical devices. He has three national patents for his invention of the "Laparoscopic Access Trocar", "Safety Syringe" and "Oral Vaccine Reconstitution & Delivery Device" and two PCT's filed for his invention of the “Safety Syringe” and "Oral Vaccine Reconstitution & Delivery Device". His efforts on the safety syringe have been acknowledged by the “Wellcome Trust, UK” and the invention has been awarded the Silver Prize at the Seoul International Invention Fair 2012. He also has the distinction of being honored twice at the Rashtrarapati Bhawan, by display of his innovative technologies during the exhibition on "Innovations in Medical Science and Biotechnology”.
Mr. Ketan Vadodaria Dr. Ketankumar Vadodaria is working as Head Of Medical Textile Division at The South India Textile Research Associations, Coimbatore, India. He is holding 10 years of experience and worked in the teaching, R & D, industries. Dr. Ketankumar Vadodaria holds a Ph.D in Textiles from Heriot-Watt University, UK. As an academic he has published in various reputed international journals and has spearheaded vital industrial research projects at SITRA. Currently, he is supervising a number of projects funded by various government agencies such as DST-Nanomission, DRDO, BIRAC, and Ministry of Textiles.
Mr. Hiten
Bheda Mr. Hiten Bheda , a Chemical Engineer by training has been associated with plastics since the beginning his career. He pursued a BS degree in Chemical Engineering from the University of Tennessee, Department of Chemical and Polymer Engineering, Knoxville, USA where his interest in Polymer processing was nurtured. He continued his education at the University of Connecticut to obtain a Masters Degree in Chemical engineering. During those years he was fortunate to learn about polymer processing and train under some of the renowned professors of Rheology. After returning to India he was associated in conversion of Engineering Plastics and have worked on Casting of Polyamides, Polyurethanes as well as extrusion of EP and High Performance Polymers. He has closely worked with many OEM’s and Govt institutions for successful application of these products involving extensive design and testing of materials for qualification. Currently he is Managing Director of Vinit Performance Polymers Pvt Ltd., engaged in conversion and CNC machining of engineering plastics and high performance plastics under POLYMAT brand. The company pioneered extrusion of high temp materials like PEEK in India. He has served the trade in the capacity of Hon Secretary AIPMA, Hon editor of Plastic News, and currently is Vice President West Zone AIPMA. He has represented AIPMA for Govt advocacy on fiscal matters like budget and GST. Active member of SPE, he is keen to further cause of plastic processing through knowledge enhancement. He is member of Tau Beta Pi, a honorary engineering fraternity based in the USA. He spends his free time to support social causes through family trust providing medical help and vocational training in suburb of Mumbai, is associated with education trust BNKCT as Managing Trustee.
Mr.
Anand Srinivasan Anand Srinivasan known as Andy, a chemical engineer from Bengaluru, pursued his Masters at Penn State University and joined Bayer at Pittsburgh as a process engineer. He moved to different roles within the organization from process technology, to project engineering, HES, and production. After 12 years with Bayer USA, Andy moved to India and took over as Plant Manager at a production facility in Ankleshwar, and then headed the Supply Chain Center in Mumbai. Currently he heads the polycarbonates business, a growing business with a turnover of over $160 mio. During his free time he enjoys time with his 2 little kids and wife, and loves sketching, music, and community service activities. He also runs a rural school to provide basic education to the under privileged kids in his home town near Mysore.
Dr.
D.D. Kale Professor D. D. Kale is a Chemical Engineer. He is born on November 16, 1945. He obtained his Ph. D. from University of Salford, UK. He has a teaching experience over last 40 years. He retired from University of Mumbai’s Department of Chemical Technology, UDCT, Mumbai in 2005 as a Professor of Polymer Technology and as a Head of the Department of Polymer Engineering. At present, he is technical advisor, Giriraj Group, Mumbai. He has been consultant to many plastics industries. He is a member of high power expert committee to Government of Maharashtra on environmental issues. He has been a Visiting Professor in South Korea. After superannuation in 2005, he has worked with Reliance Industries Ltd. for three years. He was a Director of Shroff Rotary Institute of Chemical Technology in Ankaleshwar for a year where he helped to set up the college of engineering. His research interests are in polymer processing, rheology, product design and recycling. He has guided 28 Ph. D. and 65 Masters Students. He has published more than100 papers in peer reviewed journals. He has one patent to his credit. He has presented papers in many International conferences such as IUPAC and travelled widely. He is Vice President, SPE India. He is associated with many professional bodies such as PLASTINDIA, All India Plastics Manufacturers Association, (AIPMA) IPI and SPE etc.
Dr. Prashant
Jha Dr. Prashant Jha is a physician, engineer, entrepreneur and a medical editor. He teaches at AIIMS & IIT Delhi where he directs a post-graduate Fellowship program in medical device innovations and entrepreneurship. He also serves as an adjunct professor of Healthcare Innovations at various medical, engineering and business universities in Japan, Australia and Europe. Dr. Jha has invented over a dozen medical devices in domains of gastroenterology, women's health, ENT, paediatrics and Intensive care medicine. He is a serial entrepreneur and has set up enterprises in healthcare, education and internet technologies over last 15 years. He is the founder & editor of BMJ Innovations, world's first general medical innovations journal and also serves as the Senior Editor for The BMJ in South Asia.
Shri N.K.
Balgi N.K. Balgi is Director on Board of Milacron India Pvt. Ltd. He holds Bachelor degree in Engineering. He has been serving the Plastics Industry for the last 47 years. “NK” has worked with: Klockner Windsor India and Larsen & Toubro - Plastics Machinery Division, before taking over leadership position at Milacron India. Under his leadership the company has attained leadership position in the Indian market and has spread it’s presence over 46 countries. He is recipient of “The James A.D. Geier Leadership Award” - an award instituted by Milacron in the name of their outstanding leader - in the year 2008. Industry Representations:
A.S. Rao Summery
Current Affiliations
Academic
Dr Ramanan Dr. Ramanan
Lakshminarayanan, Chief Technology Officer of Sahajanand Medical
Technologies Surat, the leading Coronary Stent Manufacturers of
India with Global Imprints, is an aluminous of IIT Madras, BITS
Pilani. Dr Ramanan is a mechanical engineer, with specialisation
in Design, Technology Operations and Six Sigma Product & Process
Quality.
Mr. Ganesh Sabat Mr. Sabat has
got more than 15 years of global experience of working in USA
and India. He has got more than 5 years of experience in medical
device industry. Currently Mr. Sabat is working as the CEO of
SMT Pvt. Ltd. He has successfully expanded SMT presence in India
as well as in 40 countries across the world. Under his
leadership, SMT is developing as a global leader in
cardiovascular market.
Dr. Nishodh
Saxena Dr. Nishodh Saxena PhD, is a resourceful professional offering about 35+ years of experience in executing Quality, Regulatory Sciences, Audits and Compliance for greenfield / brownfield projects for Pharma, Biopharma, Medical Devices & Laboratory set up, expansion, modernization, installation & commissioning of manufacturing unit. He is also the Founder and Managing Director of Pharma Knowledge Centre (PKC) “My Learning Life” engaged to bridge the real time Knowledge gap between Academia and Industry to make Students “Industry Ready” for Pharmaceutical, Bio-pharmaceutical, Medical Devices and Clinical Research Organizations. PKC is an initiative of Nishodh Saxena Advisors LLP (NSAL), offers specialized Quality Consulting, Training, Regulatory Compliance and Quality Assurance for Pharmaceutical, Medical Device, Biotechnology, Food and FMCG companies. PKC provides customized, value-added solutions, processes and enhanced quality standards to optimize business process efficiencies and minimize regulatory risk. PKC is an ISO 9001: 2015 certified professional training and consulting service provider focusing on providing Implementable Industrial Knowledge to the students and associates. PKC ensures the real return on the Consulting and Training provided when our participating candidates start giving Quick and efficient work to the industries without jeopardizing Quality. Dr. Nishodh has served and significantly contributed to many reputed organizations during his career like Jubilant Life Sciences Ltd., Omni Actives Health Technologies Ltd., USV Ltd, Zydus Cadila Healthcare Ltd., Intas Pharmaceuticals Ltd. and Dr. Reddy’s Lab Ltd. In various C level positions.
Mr. Sanjay
Shah PROFESSIONAL PROFILE :
EDUCATION :
TECHNICAL SUBMISSIONS :
PROFESSIONAL EXPERIENCE : 1. QUALITY SYSTEM AUDITS & CONSULTANCY Consulting Companies for CE marking certification of Medical Devices. Consultancy for CE Certification for all Class of Medical Devices e.g. Infusion & Blood Transfusion Sets, IV Cannulas, Syringes & Needles, Various Catheters, IOL, Orthopaedic Implants, Surgical Ophthalmic Blades & Cannulae, Surgical Gloves, IUDs, Sutures, Coronary Stents & Drug Coated Stents and Balloon Catheters, etc. etc. More than 10 years experience in setting up manufacturing facilities for Coronary stents and drug eluting stents. Technology transfer assignment for an Indian Company for developing and transferring process technology for DES including process and analytical method development and validation as per CE & US FDA (CDRH) requirements. CE marking for BM Stents & various Drug Eluting Stents including Paclitaxel, Sirolimus and other Limus group drugs. Plant design to comply with international requirements. Designed & executed DQ, IQ, OQ, PQ validations, process validation for sterilization and stability studies. Worked on various stages of regulatory submissions including biocompatibility, pre-clinical & clinical studies. Planned, supervised and submission done of non-clinical & biocompatibility studies in international labs under personal supervision & guidance and follow up including site audits and CRO interaction. Consultant for UNIDO cluster program for QMS & CE marking of Medical Devices. Bio Pruner Mentor with EDI & MSME Cluster Widely travelled in USA, Canada, Europe, China, UAE for consultations / Audits / executing projects; attending conferences and technical presentations. INDUSTRIAL POSITIONS HELD :
CONFERENCES, WORKSHOPS, EXHIBITIONS :
Dr. Chirag
Patel Practicing since 10 years as Infection preventionist, Clinical Microbiologist, academician and guide for MBBS and MD students in medical college.
Publications: 6 - international and national level research
papers Research projects: Completed - 9, ongoing - 8 Primary are of interest: Indwelling medical device associated infections, Multi-drug resistant organism in healthcare associated infections, Microbial diversity in Blood stream infection and Respiratory tract infections.
Mr. Partha Mohapatra Mr. Partha Mohapatra is working as Lead Healthcare ( India ) & Technical Support with INEOS Styrolution India Limited. In his present role, he is actively involved in Application & Product Development along with Technical support, with key focus on new business opportunities for styrene in medical device industry. Mr. Mohapatra is Post graduate in Plastic technology from CIPET, Hyderabad and has an M.B.A ( Marketing ) from I.G.N.O.U ( Delhi ) with 19 years’ experience in plastics processing & raw material industry . He has expertise in processing of engineering plastic & is actively engaged in business development/ marketing of styrene’s products for healthcare industry. He is involved in new projects developments with pharmaceutical packaging & medical disposable device industry. He provides technical/development support to customer from initial stage to project commercialization stage. He possesses diverse technical sales marketing experience in the field of medical grade styrenic polymers.
Mr. Umang
Shah CLARIANT is one
of the world’s leading Specialty Chemicals company. Mr. Umang
Shah is a National Sales & Marketing Manager for Masterbatch &
Compounds for Medical & Pharma Segment (HPS) since Dec, 2015 and
based at head quarter in Navi Mumbai. He is helping Indian
manufacturers to develop various Medical devices & Pharma
packaging applications meeting the regulatory requirements for
the domestic & export markets.
Dr. Alok Ray Executive Director Stanford-Indian Biodesign Dr. Alok R. Ray is Consultant Professor at School of International Biodesign, All India Institute of Medical Sciences, and New Delhi, India. He was Professor and Head of Centre for Biomedical Engineering, Indian Institute of Technology, Delhi. He was also concurrently Professor at All Indian Institute of Medical Sciences, New Delhi, India. Dr. Ray is Executive Director of Stanford-Indian Biodesign program. He was a Fogarty Fellow of National Institute of Health, USA at Centre for Polymeric implants, University of Utah, USA. He was a fellow at University of Liverpool, UK. He was a visiting professor at All Union Cardiology Institute, Moscow, University of Leiden, Netherlands and Max Planck Institute for Polymer sciences, Mainz. Prof. Ray has made notable contributions in the area of biocompatible materials. Unique feature of his research is that starting from synthesis/modification, characterization, he has gone up to the stage of engineering and designing of such materials for use in human medicine and surgery viz.: medical devices and implants, drug delivery systems, catheters used for blood vessels. He has developed 11 biomedical products and published over 150 articles in professional journals. 26 students have been awarded PhD degree under his supervision. He is a consultant to several medical device and diagnostic industries. He was President of Society for Biomaterials and Artificial Organ (India). Prof. Ray has been awarded Tata Innovation Fellowship in recognition of his research contribution in the area of material used in Human Medicine and Surgery.
Mr. Sarabjot Singh, Mr. Singh is an entrepreneur and Founding Member of Sterimed Group of Industries. He has done Diploma in Polymer Technology from Indian Plastic Institute (IPI).
He has over 30 years of experience in the field of manufacturing of Disposable Medical Products and 17 years of experience in the field of manufacturing of Industrial and Medical Adhesive Tapes.
Mr. Sarabjot Singh is also experienced in the field of manufacturing of Hotmelt Adhesives and manufacturing of Nonwoven bags.
Dr Inder Jain
He did his graduation from Dr SN
medical college Jodhpur and trained in Intensive care at Bombay
Hospital.
Mr. Manoj Bhardwaj
Manoj Bhardwaj is the Managing Director of SMC Medical Manufacturing headquartered at Bangalore, India. SMC Medical Manufacturing is a fully owned subsidiary of SMC Ltd headquartered in Somerset, Wisconsin US. The core competencies of SMC Ltd spans across medical device design, tool design and build, molding, manufacture and assembly of medical devices as well as industrial automation and robotics. Manoj is a polymer engineer with over three decades experience in Manufacturing, Consulting and IT sectors. Manoj has hands on experience in compounding of polymers, alloys and blends as well as downstream polymer processing operations like extrusion, injection molding, welding, machining, printing, decoration, etc. He also has experience in manufacture of extrusion and injection molding machines, product design, mold design and mold making. Besides polymer science, Manoj’s background includes business strategy consulting, business process consulting, supply chain and logistics, new product introduction, lean manufacturing, program management as well as IT/ ITeS consulting, infrastructure and services.
Mr. Ravi Shrivastava Experience: About, 27 years in handling sales and marketing functions in domestic and international business. Have worked with well-established global western multinational companies and start up companies of repute from India. Currently designated as CEO with major responsibilities of Global Business development in Omni Lens (P) Ltd., manufacturing wide range of CE certified ophthalmic medical devices and other pharmaceutical products meeting International standard. Key responsibilities include strategic planning, identification of emerging market areas, new product development besides strengthening the present business in International markets like U.S., Latin America, Europe, Japan, China, Korea etc. besides strengthening existing business. Have travelled widely in about 90 countries across U.S., Latin America, Europe, Africa, Middle East, UAE, Korea, China and many other Asian countries. Academic: Post Graduate from Allahabad University Courses / Training programmes: 1. Attended MDP
in Finance from IIM Bangalore. Visiting Faculty: 1. SRI SIIM –
Delhi Member: 1. Member, Academic council, NIPER, Ahmedabad Subjects of Interest: 1.
International business
Mr. Vipul Sheth Mr. Vipul Sheth is Managing Director of Matrix Meditec (P) Ltd. – the company engaged in manufacturing and exporting of orthopaedic implants and instruments. He is also heading company named Life Sight Surgicals (P) Ltd - a company engaged in manufacturing and trading of Ophthalmic Instruments and intra ocular lenses. He has significant contribution in bringing and educating phaco emulsification technique in India. He is a distinguished personality in the field of medical devices & instrumentation having experience of more than 20 years. He has been representing CARL ZEISS, Germany for more than a decade. He has also attended numerous workshops / seminars organized by SYNTHS, ZEISS in Davos, Switzerland, USA Germany. Mr Sheth is a science graduate and his company Matrix Meditec is actively involved in bringing new / unique technologies in the field of orthopaedic implants and instruments.
Mr. Vivek Sharma Mr. Vivekanand
Sharma is a Director of Sharma Pharmaceutical Pvt. Ltd. He got
an Engineering (Mechanical) degree from Parul University,
Vadodara. Mr. V. K. Sharma has started his career in 2006 as a
Design Engineer and through his vision and keen interest in
product design; he was also much interested in Production as
well as Strategic Planning.
Mr. Maulik
Patel Mr. Maulik Patel attained his B.tech Mechatronics in 2008. As he inherited the passion for technology he began to actively participate in the SLTL group's Production and Development departments. In 2009, Mr. Maulik Patel played an instrumental role for the resolution of SLT Gmbh which is a German Subsidiary. He then channelized his skills to uplift the sales and marketing across the Indian subcontinents. Till date, Mr. Maulik Pate is responsible for the international business adding lists of achievements and enhancing company’s portfolio. Executive Director at Sahajanand Laser Technology Limited, he has established SLTL Group on global landscape and is contributing to even great expansion.
Mr.
Sanjay Chotalia Sanjay Chotalia completed Bachelors in Polymer engineering from MIT collage Pune University, & Diploma in Plastics Engineering from Shri Bhagubhai Polytechnic, Mumbai University and done MBA in marketing from ITM Collage. Total experience of 10 years in the field of Engineering Plastics like Polycarbonate, Nylon 6, PBT, PMMA and working with Covestro since 2012 as Manager - Technical Sales and Medical Segment expert for Polycarbonate resin. Handles customer base of Electrical & Electronics, Industrial & construction segments.
Dr. Jaishree
Kasliwal Name – Dr Jaishree Kasliwal Educational Qualification – PhD in Microbiology Total working experience – 35 years in the field of Laboratories and Research & Development of formulations of FMCG products. Experience in the field of audits on standard 17025 ; ISO 9001 and ISO 13485 – Since 1995 Since 2013 Associated with NABCB /QCI involved in assessments based on ISO 17021 to confirm the compliance of Certification bodies certifying manufacturers for Pharma products and Medical Devices. Involved in developing scheme for Indian Certification for Medical Device – ICMED – 9000 and ICMED – 13485 launched in March 2016.
Mr. Masayuki
Sakai Masayuki Sakai
is qualified MR or Medical Representative. He has over 20 years
of experience in product management, technical business
development in global companies like Mitsubishi Chemical, Schott
Glass and INEOS Styrolution. During his professionals, he has
explored various avenues of healthcare, like pharmaceutical,
diagnostic device and regulatory procedures.
Dr. M.L.
Aggarwal Name : Dr. M.
L. Aggarwal
Responsibilities :
Training / Courses Attended:
Membership of National & International Societies /Committees:
Dr. Manish Rachchh
Dr. Manish A. Rachchh is currently working as a Director (R & D) & CEO of Accuprec Research Labs Pvt. Ltd at Ahmedabad. Before this he was working as Head of Center of Pharmaceutical Studies, Gujarat Technological University (GTU), Ahmedabad. He has completed his M.Pharm and Ph. D with specialization in Pharmacology. He is also a Registered Patent Agent with Patent Office of India. He has total 14.5 years of teaching as well as research experience. His research work has been accepted by various reputed national and international publications. He has presented 22 research papers in National and International conferences. He has filed 11 patents for his own research work and licensed out 3 patented technology to one of the Ahmedabad based Pharmaceutical company. So far he has guided 13 M. Pharm students and 2 PhD students in their research work.
Mr. Padmin Buch
Renowned expert of IPR &
Project Management
Mr. Anupam Gupta
Educational Qualification – B.Tech (BITS, Pilani) & PGDQMS (NMIMS, Mumbai)
Mr. Kamlesh Daga
Director - Plasti Surge Industries Pvt. Ltd., Amravati. A well reputed and fast growing company engaged in manufacturing of Disposable Medical & Surgical Products and Healthcare Kits. In 1989, the company took over the operations of a sick unit in the same line of business. Thereafter it has never looked back and today Plasti Surge Industries Pvt. Ltd. is known for its innovative products in the Medical and Healthcare sector.
Partner - Rajesh Gas Service, Amravati. Renowned distributers for Bharat Petroleum Corporation Ltd. domestic LP Gas having a large quantum of not less than 30000 customers across the district.
Director - Plasti Surge Industries Pvt. Ltd., Unit-2, Amravati. (Formerly named as Dimple Silk Mills Ltd.) A sick unit taken over in the recent past and now taking up a new shape to cater to the plastic film industry.
CEO - Bathgate Laboratories Ltd., Nagpur. This company is the newest addition to the PSI family very recently taken over. It is a sick pharmaceutical unit where new developments are thought about and will take shape soon.
Managing two own Wind Turbines, one in the state of Rajasthan and the other in Tamilnadu, of 1.85 MW generation capacity.
Mr. Gurtej Singh Narang
An experienced polymer chemist with an in-depth knowledge of chain growth and step growth polymerization techniques, molecular weight characterization, morphology characterization, transport property measurements, thermal and mechanical characterization.
HIGHLIGHTS
Chain Growth Polymerizations: 1 year experience in cationic ring opening polymerizations.
Step Growth Polymerization: 4 years’ experience in poly (arylene-ether) synthesis and monomer synthesis.
Presently is is Head & R&D at Sterimed Group and responsible for Development of medical grade adhesive with constant long term adhesion characteristics and Development of lateral flow media for diagnostic strips. |
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