4th ANNUAL MEDICAL DEVICE REGULATORY AND QUALITY SUMMIT 2019
The existing regulatory framework for the medical devices in India is inadequate for the USD 6 billion Industry. Medical Devices were unregulated in India until recently. The first draft of the Medical Device rules came in existence in 2016 and after consulting the industry and stakeholder, as second draft if the draft was issued in October 2016 and later in January 2017. The 2017 draft has been effective from January 2018, thereby giving the industry time to adapt to the new rules. The rules framed around the guidelines of the Global Harmonization Task force (GHTF) ensure that the Indian norms governing medical devices are on par with those in vogue globally. Medical devices, henceforth, both produced and imported, will conform to the best international practices o manufacturing, ensuring the prevalence of quality products in India. The industry, which is been growing at a rapid pace, hence the need for clarity on regulations, export and import guidelines is essential for the Industry.
The 4th Annual Medical Device Regulatory and Quality Summit 2019 will create a platform for regulators, industry stalwarts to come under one roof to discuss and share ideas that would not only benefit their organisations, but at large the industry as well. The 4th Annual Medical Device Regulatory and Quality Summit 2019 will review the evolving regulations, their impact on the industry as well as take an in depth look into areas of quality control and assurance.
Elmas Certification and Management Systems
Senior Director, Head Corporate Quality
Biocon Biologics India Ltd.
Asok kumar Raghavan Nair
Director Strategic Global Regulatory Affairs
Head Regulatory Affairs
Quality & Public Business – India & South Asia Biomerieux India Pvt. Ltd.
Dr. Bina Naik
Chief Operating Officer
CBCC Global Research LLP
Dr. T. C. Ganesh Babu
Head - Clinical & Regulatory Affairs
(CARIn Division) Carl Zeiss India (Bangalore) Pvt. Ltd. ZEISS Group
A. Ganesh Kumar
Head - Quality/ Regulatory Affairs
Siemens Healthcare Pvt. Ltd.
Associate Director – Regulatory Affairs & Quality Assurance
Boston Scientific India Pvt. Ltd.
Head-QA & Regulatory
RAS Lifesciences Pvt Ltd (a BioMerieux Company)
Lalit Mohan Sharma
Scientific Officer (E)
Northern Regional Regulatory Centre, Atomic Energy Regulatory Board (AERB), Govt. of India
Site Head of Quality (APAC R&D)
Boston Scientific Pvt. Ltd.
Rihim Pharma Consultancy Pvt. Ltd.
Regional Regulatory Manager South Asia
Reckitt Benckiser (India) Pvt. Ltd.
Country Manager - India and South East Asia, CADFEM
Engineering Services India Pvt. Ltd.
Group Quality Head
Healthium Medtech Pvt. Ltd.
Director RA & QA
Terumo India Pvt. Ltd.
Director - Quality & Regulatory
Philips India Ltd.
Uhlmann India Pvt.Ltd.
Vice President - Health Policy & Govt Affairs
GE Healthcare South Asia
Head - Regulatory Affairs, Quality Assurance and Govt. Affairs
Stryker India Pvt. Ltd.
KEY CONFERENCE FOCUS AREAS
- Changes and advancements in Regulations
- Regulatory Framework and Implementation
- Restructuring Strategies
- Risk Management
- Regulatory implications on medical device packaging
- Quality control procedures, techniques and norms
WHO SHOULD ATTEND?
- Government Authorities
- Medical Device manufacturers
- Medical Device distributors
- Quality control
- Quality Assurance
- Registration and regulatory consultants
- Medical Device packaging companies
- Solutions Providers
FROM WHICH DEPARTMENT?
- Legal & Regulatory Affairs
- Government Affairs
- Product Regulations
- Quality Control & Assurance
- Research & Development
- New Product Development
- Packaging and Labelling
- Detailed updates on the regulation and approval of Medical Devices and IVDs
- Take away an in-depth understanding of the registration requirements and expectations
- Essential updates on post market surveillance and vigilance reporting
- Examine IVD registration requirements and expectations across the region and learn how to successfully meet these in practice
- Understanding the EUMDR, requirements and expectations
- Discover country specific labelling requirements and ensure you remain compliant to changing expectations