|
Invited Speakers & Panel Experts : Profile
Mr. Harshit Thakkar
Project Manager
DEKRA Certification B.V., USA
Mr. Harshit Thakkar is a
Project Manager for DEKRA Certification B.V. in
Chalfont, PA, USA. Mr. Thakkar is a lead auditor for
CE and ISO 13485:2003 audits (including CMDCAS) and
also performs Technical File and Design Dossier
reviews for manufacturer’s seeking CE marking for
non-active and active medical devices. Mr. Thakkar has
seven years of experience working in the medical
device industry in the field of engineering, quality
and regulatory affairs. Mr. Thakkar holds a Masters
Degree in Biomedical Engineering from University of
Southern California, Los Angeles, USA and Bachelors in
Biomedical Engineering from D. J. Sanghvi College of
Engineering, Mumbai, India.
Mr. Leendart Santema
General Manager
Consultancy Bureau Santema, The Netherlands
-
Consultancy work in medical sector
-
Training young doctors and nurse practitioners in
total pain management and anaesthesia
-
40
years’ experience in all medical device sector
-
Knowledge and application of the total medical
device industry
-
Not
only theoretical knowledge but also the application
of practical use of the medical device and medical
technology (patient side)
-
Has
more than 12 years experience in this specific
field. Carrying out Audits, giving training in Sales
and Marketing. Specialized in product related
presentations and their product related applications
by practical work experience in the OR. Market
Sectors: Intensive care medicine - coronary care
medicine - Anaesthesiology - Pain Management -
General Surgery - open heart surgery - Neuro-Surgery
Mr. Apur Lathiya
Executive Vice President Sales and Marketing, USA
With
over 15 years of experience in precision
thermoplastics extrusion for medical devices, Apur
Lathiya applies his experience and expertise to lead
Vesta’s sales and marketing organization. Apur
transitioned into this role from the VP and General
Manager of Vesta Thermoplastics Division. He
previously worked at ExtruMed, most recently as Chief
Operating Officer. Mr. Apur enjoys working with a
group of highly motivated colleagues as they strive to
positively impact overall business performance. He has
a bachelor’s in physiological sciences from UCLA and a
master’s in business administration from the
University of Southern California.
Mr.
Sachin Sapar
Technical Service & Technology Manager (General
Industry)
Henkel Adhesive Technologies India, Pune
Mr.
Sachin earned his Bachelor of Engineering in Polymer
Engineering form Maharashtra Institute of Technology,
Pune University. He then got his MBA in Finance from
Symbiosis Institute of Management Science, Pune.
Mr.
Sapar has 17+ years of experience in engineering
plastics, adhesives, coating & sealants for variety of
applications across many industries like Medical,
Appliances, Automotive, composites, and process
industries. He has worked in variety of roles such as
R&D, Application Development, Engineering, Technical
Service & Sales., Mr. Sapar has been with Henkel
Corporation since last two years and currently heading
Technical Service & Technology Group for General
Industry- SBU.
Dr.
Alok Ray
Prof. & Head
Center for Biomedical Engg, IIT & AIIMS, Delhi
Dr.
Alok R. Ray is Professor at Centre for Biomedical
Engineering, Indian Institute of Technology, Delhi. He
is concurrently Professor at All Indian Institute of
Medical Sciences, New Delhi, India and the Director of
Stanford-Indian Biodesign program. He has received his
Ph.D. from University of Delhi on Biopolymers. He was
a Fogarty Fellow of National Institute of Health, USA
at Centre for Polymeric implants, University of Utah,
USA during 1982 to 1984.
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 acquired the reputation of being
a leader in the area of compatibility of materials
with living tissues. He has developed nine biomedical
products and published over 150 articles in
professional journals and is a consultant to several
industries. He was President of Society for
Biomaterials and Artificial Organ (India) from 2009 to
2011.
He has
been awarded TATA INNOVATON FELLOWSHIP for the year
2007-2008 in recognition of his research contribution
in the area of material used in Human Medicine and
Surgery.
Mr. Ravi Shrivastava
CEO
Omni Lens Pvt. Ltd., Ahmedabad
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 inOmni
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.
2. Course on leadership from IIM Indore.
3. Communication skills from ASCI, Hyderabad.
4. Managerial assessment of proficiency from Credo
consultancy, U.S.
5. Situational Leadership, Ken Blanchard, Singapore.
6. Management style, by Ms Lauren Larson Paugh, U.S.
7. Assessment centre and training the trainer, P&P
Consultants.
Visiting Faculty :
1. SRI SIIM – Delhi
2. IIMPM – Ahmedabad
Member:
1. Member, Academic
council, NIPER, Ahmedabad
Subjects of Interest :
1. International
business
2. Sales and Distribution management
3. Organizational behaviour
4. Consumer behaviour
5. Corporate communication
Mr. Sanjay Shah
Managing Director
Unikal Consultants, Ahmedabad
Mr.
Sanjay Shah is an experienced Quality System
Consultant with special emphasis in medical devices.
An expert in auditing and determining the adequacy,
effectiveness, and degree of the company’s compliance
to the standards and regulations: ISO 9001, ISO 13495,
Quality System Regulations & c- GMP.
He is
an experienced regulatory consultant in European
Medical Device directives for CE certification of
medical devices, FDA requirements like 510k compliance
and c-GMP certification regulations for manufacture of
medical devices including sterile devices and drug
device combination products.
His
company demonstrates their expertise in preparation of
Device Master File, eCTD, for devices from class 1 to
class 4 (Ito III or A to D) and related documentation
like Quality Manuals, Policies, Standard Operating
Procedures. His company consults in preparation of
Drug Master File (DMF) for API and regulatory
submissions.
Mr.
Shah and his team have done projects on designing and
executions of medical device manufacturing plants and
executing commissioning of these plants.
He has
been adviser for technology transfer on Coronary
Stents including Drug Eluting Stents including
execution of international project.
He has
travelled widely all over the world including many
European Countries, USA, China, Taiwan, Middle East
etc.
He has
done his Masters in applied Science from University
Department of Chemical Technology, Bombay University
now Institute of Chemical Technology (an University)
Page
1 :
2 :
3 :
4 :
5 :
6 :
7 :
8 :
9 :
10
: 11
: 12
: 13
: 14
: 15
: 16
: 17
: 18 : 19
: 20
: 21 |
