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Track - I :
Workshop On Recent Changes To Biocompatibility Testing :
Manufacturers’ Perspective
Registration : 8:30 AM To 9:00 AM, Technical
Session : 9:00 AM to 11:30 AM
To Be
Conducted By : 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 in detail the 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.
Coordinator :
Mr Sanjay Shah,
CEO, Unikal Consultants , Ahmedabad
Experts :
-
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
Track – II
: Drug / Medical Device Combination Products :
Registration : 11:00 AM To 11:30 AM, Technical
Session : 11:30 AM to 13:30 PM (Followed by Lunch)
Highlights
:
Overview on
drug / device combination products, Applications,
Regulatory requirements, Testing
requirements, Clinical Trials
Session Co-ordination : Accuprec Research Labs Pvt Ltd.
The global
drug device combination product market size was valued
at USD 96.3 billion in 2016 and is
expected to
exhibit a CAGR of 7.9%. Driven by growing patient and
physician preference for minimally
invasive
procedures and consistent-dosing treatment alternatives.
Such
combination products are emerging as innovative medical
products due to their contribution in
advancing
medical care and are thus expected have an impact in the
coming years.
Examples of
Drug / Device Combination Products :
Prefilled
Drug Delivery Systems :
Prefilled
syringes, Prefilled auto injectors , Prefilled pen
injectors , Prefilled on-body delivery systems,
Dry-powder inhalers , Metered dose inhalers , Prefilled
nasal sprayers, Transdermal patches, – Oral Vaccine
Delivery Devices.
Medicated
Devices :
Drug-coated
stents , Drug-coated catheters , Drug-coated pacemaker
leads , Antimicrobial surgical scrubs , Antimicrobial
wound dressings , Antimicrobial Sutures, Drug
impregnated surgical mesh, Antibiotic bone cements ,
Spermicidal condoms & more.
Speakers /
Panel Experts :
1.
Dr. Viranchi Shah :
President, IDMA & MD, Saga Laboratories
2. Overview
of the Medical Device Regulations :
by Dr. Arvind Kukrety :
Deputy Drugs Controller, CDSCO , Zonal
Office, Ahmedabad
3. Stent
– Man Made Marvel of Device and Drug Combination
by Dr
L Ramanan
: Chief Technology Officer, Sahajanand Medical
Technologies, Surat
4. Drug
/ Device Combination Products : Market Overview and
Opportunities :
by Dr.
Atul Sardana :
Director, Alfa Corpuscles Pvt. Ltd., New Delhi
5. Significance
of Intellectual Property Righst (Mainly Design and
Patent) In Drug Device
Combination Products :
by Mr.
Padmin Buch :
BoA Chairman, Accuprec Research Labs Pvt. Ltd.,
Ahmedabad
6. Requirement
of Regulatory Testing for Drug / Device Combination
Products :
by Dr.
Manish Rachchh :
Director (R & D) & CEO, Accuprec Research Labs Pvt
Ltd.
7. Dr.
Chirag Patel :
Asst. Prof., Microbiology, Shree Krishna Hospital
Karamsad
8. Mr.
Anupam Gupta :
National Accreditation Board for Certification Bodies
(NABCB), New Delhi
9. Testing
Of Prefilled Syringes - a case study
- Mr Pratik Banker :
Hem Techsys Pvt Ltd,
Vadodara
10. Quality
and Regulatory Perspective for Drug / Device
Combination Products:
by Ms.
Preeti Vani : Head Medical Device Division,
Sahajanand Laser Technology Ltd.
Accuprec Research Labs Pvt Ltd., Ahmedabad (2 ½ Hours)
Accuprec
Research Labs Pvt Ltd is 21 CFR compliance laboratory
providing ultimate solution to its medical device as
well as pharmaceutical clients by providing range of
services like physical testing, chemical testing,
biological testing, Extractable and leachable testing,
risk assessment, biocompatibility testing as per ISO
10993, MHRA and USFDA guidelines. Many medical devices
are integrated with pharmaceuticals and vise a versa.
Track - III
: Workshop on Manufacturing of Orthopaedic Implants :
Highlights
: Materials, Design, Regulations, Testing, Process &
Patient Safety (3 Hours)
Registration and Lunch : 1:30 PM To 2:30 PM,
Technical Session : 2:30 PM to 5:00 PM
Coordinator :
Mr Sanjay Shah,
CEO, Unikal Consultants , Ahmedabad
Global
Orthopedic Implants Market was valued at $47,261 million
in 2016, and is expected to garner $74,796 million by
2023, registering a CAGR of 6.8% during the forecast
period 2017 - 2023.
The Indian
Orthopedic Devices Market is likely to grow between 15
to 20% for more than one decade. As a largely
out-of-pocket healthcare market with less than 400
Million Indians covered by insurance, the medical
devices market benefits from higher disposable income in
an economy growing at 8 to 10% additionally, growing
incidents of diabetes, obesity, osteoarthritis and
Osteoporosis are further enhancing the clinical need.
Thus, while there are many opportunities, the
Indian Orthopedic manufactures are facing number of
challenges. Challenges of Raw Materials, Technology,
Regulatory Requirements & Complexities, Human Resources
& Skilled Manpower, Quality Demands along with of
course, market competitiveness.
In this
special session to be held on second day of the two day
conference, Industry Experts, Regulatory Authorities &
Professionals will discuss the critical issues specific
to this emerging sub-sector of Indian Medical device
Industry.
Shortlisted
Speakers / Panel Experts :
1.
Overview of the Medical Device Regulations :
by
Dr. Arvind
Kukrety :
Deputy Drugs Controller, CDSCO , Zonal
Office, Ahmedabad
2. Orthopedic
Implants : Current status of quality standards by
Bureau of Indian
Standards : by Mr. Prakash Bachani :
Scientist &Head (MHD),Bureau Of Indian Standards,
Delhi
3. Challenges
of meeting the Manufacturing facility compliances in
Current regulatory
scenarios
by Mr. Anil Chaudhary : CEO , Operon
strategist , Pune
4. Voluntary
Certification Scheme for Indian Medical Devices
Manufacturers :
by
Mr. Anupam Gupta :
National Accredition Board of
Certification Bodies (NABCB), New Delhi
5. Challenges
and Opportunities for Orthopedic Implant Manufacturers
:
by
Mr. Vipul Sheth :
Managing Director , Matrix Meditec Pvt. Ltd.,
Ahmedabad*
Track – IV
: Medical Plastics : Materials, Processes & Markets –
Emerging Trends
Registration and Lunch : 1:30 PM To 2:30 PM,
Technical Session : 2:30 PM to 5:00 PM
Session
Chairman : Mr.
N.K. Balgi :
Director, Milacron India Private Limited, Ahmedabad
Presentations / Speakers:
1.
"Processing and Reprocessing for
Medical Plastic Devices"Dr. D.D. Kale :
Vice President,
Society
of Plastic Engineers
2. Quality
Testing of Polymers / Plastic Materials Required For
Medical Applications : Dr.
M.L.
Aggarwal :
Dy. Director (HOD Bio Division),
Shriram Institute For Industrial Research
3. Medical
Textiles From Non-Wovens (Polymers) : Opportunities :
By Dr. Ketan Vadodaria
: Head
,Centre of Excellence for Medical Textiles–SITRA,
Coimbatore
4. Clean
Rooms for Injection Mouldings – Milacron India Private
Limited
5. Medical
Grade Polymer Compounds : Importance of Right Quality
Additives and
Processing
Parameters - Mr. R.C. Gupta :
Sr. General Manager, KLJ Polymers and
Chemicals
Ltd.
6.
Testing Of Medical Device Packaging
– a case study. Mr Pratik Banker :
Hem Techsys Pvt
Ltd,
Vadodara
Panel
Discussion: Theme : Challenges Faced By Medical Plastics
Processors
Moderator :
Mr Atul Kanuga : Panel Experts : Leading Medical
Plastics Processors
Panel
Experts :
1.
Mr. Gurtej Singh Narang : Director,
Sterimed Medical Devices Pvt. Ltd., New
Delhi |
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