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Contact : Mr. D. L. Pandya
Classic Computer Services
B-4, Mandir Appt., Opp. P & T Colony, Jodhpur Char Rasta, Satellite Road, Ahmedabad-380 015. India.
Phone : +91 79 26740611 Telefax : +91 79 26754867
M : +91 9825457563
E-mail : medicalplastics@gmail.com / dlpandya@gmail.com

 

ANNOUNCEMENT

The 16th National Conference and Technology Exhibition on

Indian Medical Devices & Plastics Disposables/Implants Industry 2020

 

To be held in October, 2020

Venue : Ahmedabad Management Association, Ahmedabad, Gujarat

Click Here For More Details

Previous Show Program Overview

Theme : Medical Device Sector : Making India Globally Competitive

08:30 - 09:30

Registration And Welcome Drink

09:30 - 11:05

Inaugural Session :

 

Prayer and Welcome Address by Mr. D. L. Pandya, Conference Convener

Chief Guest :

  • Dr S. Eswara Reddy : Drugs Controller General Of India, Central Drugs Standard Control Organization, New Delhi

  • Mr. Rajneesh Tingal - Joint Secretary ( PSU / NIPER ), Ministry of Chemicals & Fertilizers,  Department of Pharmaceuticals

Key Note / Special Address :

 

Guests of Honors :

  • Dr.  H.G. Koshia – Commissioner - Food & Drug Control Administration (Gujarat State), Gandhinagar

  • Mr. Kishore Khanna, Managing Director, Romsons Group of Industries, Agra

  • Mr. Rajiv Nath, Forum Coordinator, Association of Indian Med. Device Industry (AiMeD) and Jt. MD, Hindustan Syringes & Med.Ltd.

  • Dr. Arvind Kukrety -Deputy Drugs Controller, CDSCO , Zonal Office, Ahmedabad

  • Mr. Prakash Bachani -Scientist &Head (MHD),Bureau Of Indian Standards, Delhi

  • Dr. Kiran Kalia - Director, NIPER, Ahmedabad

  • Mr. Sunil Parekh : Senior Strategy Advisor, Zydus Cadila Healthcare Group

Vote of Thanks :  Dr. Atul Sardana, Director, Alfa Corpuscles Pvt. Ltd., New Delhi

11:05-11:45

Inauguration & Visit to “Technology Show Exhibition” & Comfort Tea

 

Session – I : Panel Discussions

11:45-12:35

Panel Discussion-I, Theme : Building The Medtech Ecosystem In India

Moderator : Mr. Rajiv Nath : Forum Coordinator, Association of Indian Med. Device Industry (AiMeD) and Jt. MD, Hindustan Syringes & Med.Ltd., Faridabad

 

Panel Experts:

  • Dr S. Eswara Reddy : Drugs Controller General Of India, Central Drugs Standard Control Organization, New Delhi

  • Mr. Kishore Khanna, Managing Director, Romsons Group of Industries, Agra

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

  • Mr. Ravishankar Srivastava, Managing Director, Conquest Medtech LLP, Mumbai

  • Mr. Ravishankar Srivastava, Managing Director, Conquest Medtech LLP, Mumbai

  • Mr. Anand Srinivasan, Country Head (Polycarbonate Resin), Covestro (India) Pvt. Ltd., Mumbai

  • Dr. Alok Ray, Former , Professor & Head, Centre For Biomedical Engineering , IIT, New Delhi

12:35 - 13:45

Session - II : Theme : Competitiveness Through Materials Quality and Manufacturing

Session Chairman : Mr. Kishore Khanna, MD, Romsons Group of Industries, Agra / Dr. Alok Ray, Former , Professor & Head, Centre For Biomedical Engineering , IIT, New Delhi

 
  • "Technological Innovation in styrenics for infusion set and drug delivery housing applications" - By Mr. Masayuki Sakai, Regional Industry Lead, Healthcare APAC, INEOS Styrolution APAC Pte Ltd., Japan

  • Polymer Compounds & Masterbatch To Help Deliver Safe Treatment Globally - by Mr. Umang Shah : National Sales & Marketing Manager – Masterbatch & Compounds for Medical & Pharma Segment, CLARIANT Chemicals India Ltd, Mumbai

  • Formulating life & Enhancing solution : Global Advance Products For Local Medical Device Industry : Mr. Sanjay Chotalia : Manager – Manager - Medical Segment Expert Covestro (India) Pvt. Ltd, Mumbai

13:45 - 14:30

Lunch & Visit to Technology Display Show 2018

14:30 - 15:30

Session - III - Panel Discussion-II, Theme: “Medical Device Sector : Making India Globally Competitive -  Getting Easier or Tougher ?”

Moderator : Mr. Kishore Khanna : Managing Director, Romsons Group of Industries, Agra

 

Panel 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

  • Mr Manoj Bhardwaj, SMC Medical Manufacturing Pvt Ltd., Bangalore

  • Mr. Ganesh Sabat – CEO, Sahajanand Medical Technologies Pvt. Ltd., Mumbai

  • Mr. N.K. Balgi, Director, Milacron India Private Limited, Ahmedabad

  • Mr. Anupam Gupta : NABCB - Quality Council of India, New Delhi

  • Mr. Maulik Patel, Executive Director, Sahajanand Laser Technology Ltd., Gandhinagar

15:30 - 16:30

Mr. Rajiv Nath - Forum Coordinator, Association of Indian Medical Device Industry (AIMED) and Joint Managing Director, Hindustan Syringes & Medical Devices Ltd.

- Meeting Of “Association for Indian Medical Device Industry (AIMED)” Members. (Venue : Room No. S-7, Ground Floor)

16:30-18:00

- Refreshment Break

- Visit to :  TECHNOLOGY DISPLAY SHOW 2018 EXHIBITION

An Exhibition Displaying Materials , Adhesives , New Technologies , Manufacturing / Testing Equipments, Packaging / Sterilization Equipments And Supplies For Medical Device Industry

 


DAY : 2, OCTOBER 27, 2018, PROGRAM HIGHLIGHTS

THEME : Being Globally Competitive Through Design, Quality Materials & Manufacturing

Focused Workshops & Presentations & Panel Discussions Divided In Various Tracks running parallel Including following :

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