Medical Devices Webinar

Shaping India’s Medical Devices Regulatory Framework: Global Best Practices and Priorities

India’s medical devices industry is poised for significant growth in the next five years, with the market size expected to reach $50 billion by 2025. It includes both large multinationals and small to medium enterprises (SMEs), and it is growing at an unprecedented scale: its current market size is estimated to be nearly $10 billion. 

TIC Council fully supports the crafting of a robust medical devices rules regulatory and policy framework which lays a strong foundation towards ensuring a robust quality and conformity ecosystem for medical devices in India. 

In the healthcare sector, patient and operator safety are of paramount importance, which makes it imperative for medical devices to be of high quality and safe for their intended use, therefore a rapidly evolving medical device industry needs hand holding from all stakeholders, in order to be able to realize the government’s vision of quality and affordable healthcare for all. 

Embarking on the mission of patient safety in India, TIC council is organizing a two-day webinar on Shaping India’s Medical Devices Regulatory Framework: Global Best Practices & Priorities. The webinar will witness the presence of senior policy makers from Ministries & regulatory bodies of India, E.U & U.S along with senior industry leaders from the medical devices and TIC industry, sharing their experience, global trends and best practices towards ensuing quality and safety of medical devices. This webinar is a must-attend for industry leaders, decision makers, quality, regulatory and public affairs personnel from the healthcare sector.

Details 

The webinar will be held in two days: Thursday 28 October 2021, 14:30-17:00 IST (11:00-13:30 CET), and Friday 29 October 2021, 14:30-17:00 IST (11:00-13:30 CET)

Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience. 

Speakers: 

Day 1:  

  • Suresh Sugavanam, Chairman, TIC Council India
  • Hanane Taidi, Director General, TIC Council
  • Niranjan Nadkarni, CEO, TÜV SÜD South Asia, South East Asia, Middle East & Africa Region
  • Karthik Venkataraman, Business Manager, UL India
  • Claire Dyson, Global Vice President, Dekra
  • Kimberly Trautman, Medical Device, IVD and Combination Product Regulatory & Quality Expert
  • Latika Vats, Director, Regulatory Affairs & Quality Assurance for India Medtronic and APAC Med Committee
  • Reinaldo Figueredo, ISO-CASCO Chair
  • Sudhir Zutshi, Chair, Public Affairs, Sub Committee, TIC Council India

Day 2: 

  • Dr. R P Singh, Secretary General, QCI
  • Dr. Shailendra Singh, TUV SUD Pvt Ltd.
  • Jitendra Sharma, Managing Director and CEO, AMTZ
  • Ravi Kant, DDC, CDSCO (TBC)
  • Rajesh Maheshwari, CEO, NABCB
  • Ravi Singh, Member, TIC Council, Med Device WG
  • Dr. Girdhar Gyani, Director General, AHPI
  • Harshit Thakkar, Sr. Project Manager, DEKRA
  • Sudhakar Mairpadi, Head Quality, Regulatory and Govt Affairs, Philips India Pvt Ltd
  • Rajiv Nath, Forum Coordinator, AiMED
  • Vibhav Garg, Director-Health Economics & Govt Affairs, Boston Scientific
  • R Asok Kumar, Chairman, Regulatory Sub Committee, Adva Med
  • Dr. Aparna Dhawan, Executive Director, TIC Council India

REGISTRATION

Further Details:

The microphone function will be disabled for participants during the webinar but all questions for the presenter can be submitted through Webex via the chat function during the Q&A session at the end.

For further questions, please do not hesitate to contact – secretariat@tic-council.org

We look forward to welcoming you and/or your colleagues. 

For more information – https://tic-council.idloom.events/shaping-india-s-medical-devices

Medical Labs Trainings

MELAP – ONLINE PROGRAMS

Date: 17-18 November 2021
Program : Molecular Diagnostics in COVID 19

Time for both days: 09:30am-01:30pm
Fee – Rs 4000/- all inclusive

Registration link for Molecular Diagnostic in COVID 19 :
https://bit.ly/2Zp2rV5

For detailed information, please contact :

Ms Tripti-9958697309
Dr Jain -9810492621

Telegram group:
https://t.me/joinchat/TU5KxI1INydP7Ghr

WhatsApp group: https://chat.whatsapp.com/JRsns9vptTNJqfynaSIUsO

Facebook page
https://www.facebook.com/profile.php?id=100071765581442

Linked In page
https://www.linkedin.com/in/dr-neeraj-jain-96386446

website: www.melap.in

Global Services Conclave

Global Services Conclave 2021 – India Serves: Exploring Potential Growth Sectors Beyond IT/ITes

Global Services Conclave 2021
“India Serves: Exploring Potential Growth Sectors Beyond IT/ITes”
10.00 AM-4.30 PM, Tuesday, 9th November 2021
New Delhi, Delhi 110021

The service sector has invited considerable interest among policymakers for its larger contribution to global output, contributing almost more than three-fifths of global GDP and about half of the employment opportunities across the world.

India’s service sector is no exception to the global service composition as its share is over 60 per cent of the national output. India has emerged as a global hub for the supply of various services, and today India exports over $200 billion of services annually, which contribute to 7% of India’s GDP. Services account for 54 per cent of India’s Gross Value Added (GVA) and account for more than 40 per cent of India’s total global exports. Services exports lead directly to the employment of approximately 2.6 crores people in India while leading to indirect employment as well.

Despite the pandemic, the sector has shown immense resilience and services exports stood at $ 206 billion in 2020-21 showing a decline of only 3 per cent. Throughout the decade (2010 to 2021) the CAGR of the services sector has been 6%. Based on trends and present performance of the sector SEPC has projected a target of $250 bn for services exports in the FY 2021-22 and a target of US$ 1 trillion including IT and ITES by 2030 as suggested by the Ministry of Commerce and Industry, Government of India.

In the above context, SEPC is organising its first Global Services Conclave on 9th Nov 2021 which will be an annual feature of SEPC henceforth.

The Conclave will focus on deliberations and discussions to create a roadmap to achieve the projected target. While there will be talks on key service sectors, the focus will be on capacity building, enhancing competitiveness, MSME support, creating jobs, policy recommendations and more.

Looking forward to your participation as our distinguished Sponsor for this prestigious event. Please find attached the presentation on Sponsorship.

For any collaborations, sponsorship enquiries, please reach out to:

Mr Vikrant Wadhera +91 9910316373
Email – Vikrant.wadhera@servicesepc.org

Register for the Program Here :

QCI NBQP Programs

Upcoming Training Programs from QCI TCB , NBQP

Update from QCI TCB :

Training and Capacity Building (TCB) Cell, QCI has announced new batches of virtual training for the months of November & December 2021. Please check program calendar as listed below :

Requirements of ISO/IEC 17065:2012 for Product Certification Bodies 29-30 Nov 2021 Registration   Open INR 5000 +GST 
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017$$ 19-20 Oct 2021  25-26 Nov 2021 Registration Closed INR 5000/-   + GST (18%)  
06-07 Dec 2021Registration   Open 
ISO/IEC 17025:2017 – Risk Management requirements & implementation in Laboratories 15 Nov 2021 Registration Closed INR 2000/-   + GST (18%) 
22 Dec 2021 Registration   Open 
Uncertainty of Measurement and Decision Rule as per ISO/IEC 17025:2017 26-27 Oct 2021 16-17 Nov 2021 Registration Closed  INR 3500/-   +GST (18%)  
22-23 Nov 2021 Registration   Open  
Medical Laboratory System and Internal Audit program as per ISO 15189:2012$$  11-12 Nov 2021 Registration   Open INR 5000/-   +GST (18%)  
Lean Six Sigma Green Belt Certification 28-30 Oct 2021 Registration   Open INR 9500/-   +GST (18%)  

$  eLearning modules for these courses are also available at www.equest.co.in . Once you complete both the courses, you will get an additional ‘Competence Certificate’

The courses are designed for professionals like quality & senior management professionals from Inspection Bodies, Laboratories, Certification Bodies, Regulators, Government Bodies, Industry, PSUs, Consulting Organizations, Consultants, Training Organizations, Trainers etc. 

To deliver quality engagement, only limited number of participants are allowed for the training courses , to give sufficient opportunities for participants to participate in discussions and to clarify their doubts. 

After the completion of the course, all the participants will be issued a certificate of participation. 
Utilise this opportunity to register yourself.
We have launched various other trainings in the general domain as well as listed below :

Cost of Quality – A tool for developing Business Case for Quality Improvement Initiatives 9 November’21 
Fundamentals of Digital Marketing  18 November’21 
Organizational Values, Ethics & Office/Work Place Etiquettes 4 December’21 

Register yourself at the earliest by clicking on the link- http://bit.ly/virtualequest 

On eQuest (www.equest.co.in ), an array of courses on domains such as Environment, Laboratories, Quality, Agriculture, Healthcare, and Technology-related fields etc are listed.

A new course developed by NABL on ‘Program for Potential / Accredited / Applicant Proficiency Testing Providers on ISO/IEC 17043:2010” was launched recently . This program is designed for PT Providers to know about standard ISO/IEC 17043:2010 “Conformity Assessment – General requirements for the proficiency testing”.  

For registration and payment related queries, please contact,  
Rohit Varshney, Associate, TCB, QCI, rohit.varshney@qcin.org, Ph- 9773500376 

For any other queries, please write to  
Alok Jain, Director TCB, QCI, ajain@nabl.qcin.org, Ph. 9811352698  
Ranvijay Bihari, Dy Director, TCB, QCI, ranvijay.nabet@qcin.org, Ph. 8800424788 

Recognising Fearless Heroes

The Initiative : J Mitra, to Recognise & Felicitate these Healthcare Workers/ Frontline Warriors

#fearlessheroes

The corona pandemic has thrown everyday life out of control since March 2020.

Despite the pandemic, the lockdown, fear of contagion, and adverse work conditions, the corona warriors (healthcare workers) have stood their ground, tending to patients, and their duties – with a selfless spirit – putting their lives, and the lives of their near and dear ones at risk for the greater good of the humanity.

The Initiative : J Mitra, to Recognise & Felicitate these Healthcare Workers/ Frontline Warriors

J Mitra to recognise and felicitate these healthcare workers/frontline warriors
This will be a digital initiative
The Fearless Heroes Award

Who is J Mitra ?

The Target Recipients :

  • Doctors
  • Core Management Team at Healthcare Organisations
  • Lab Technologists
  • Logistics and Supply Chain Business Owner
  • Research Scientists, Technologists, and Innovators

The Selection Process

  • Nominate the individual you know and can verify the authenticity of their contribution
  • Review by J Mitra internal team
  • Verification & Validation email from J Mitra recognition team
  • Acceptance by prospective recipient

The Recognition Comprises :

  • A Citation / Certificate of recognition / appreciation
  • A designed infographic containing the recipient’s photograph, basic detail, and recognition message

Sustainable Solutions – Startups

Flagship Annual International Knowledge Millenium Conference

#IKMC2021

Shaping Sustainability: Investing in Our Future IKP’s Flagship Annual International Knowledge Millennium Conference

Undoubtedly, and undeniably, sustainable development is the greatest challenge of our age. From climate change and environmental degradation, poverty and disease to an increasing material and resources footprint – the global society continues to face ecological problems old and new.

How can we power the shift to sustainable practices? Why is it important to account for the value of nature in our balance sheets?

With Shaping Sustainability: Investing in Our Future as its theme, IKMC2021, IKPs flagship annual International Knowledge Millennium Conference, will deliberate virtually on these issues with curated sessions led by thought leaders.

When ?

Oct 28th – 29th 2021

More info – https://ikmc2021.com/

Register – http://bit.ly/SHAPINGSUSTAINABILITY

#ikpknowledgepark#ikplifesciencespark#sustainabilitychallenge#sustainability #sustainabilitymatters#sustainabilitygoals #buinesssustaibaility ##sustainablesolutions#sustainalityconference

NABL Training Programs

Training Programs from NABLAnnouncement

Training Programs from NABL

Download the Brochure here :

Registration Link :

Webinar for Med Tech Startups

Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Program Announcement from BIS for Med Tech Startups
Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Bureau of Indian Standards (BIS), the National Standards body of India, is formulating Indian Standards in various fields. In the field of medical devices and related aspects, BIS has formulated around 1450 standards under its Medical Equipment and Hospital Planning Division Council(MHDC).

With an objective to impart awareness regarding existing Indian Standards on medical devices among the Medtech Start-ups community as well as to explore the feasibility of formulating standards on the novel medical devices developed/being developed by them, the Medical Equipment and Hospital Planning Department (MHD) of BIS is organizing a Webinar with Medical Technology Start-ups on 26 October 2021 from 1400-1700 hrs.

The details of the link for joining the webinar are as follows:

Date26 Oct 2021 (Tuesday)
Time1400 h to 1700 h
Link to joinhttps://bisindia.webex.com/bisindia/j.php?MTID=mec53359b4f7429c481f7ef5c5ec97ebd
Meeting No.2513 899 2572
PasswordBIS@2021

You are cordially invited to participate in the webinar. There is no registration/participation fee. 

Please click on the link below to register :

Contact :
Medical Equipment & Hospital Planning Department
Bureau of Indian Standards
Manak Bhavan
9, Bahadur Shah Zafar Marg
New Delhi – 110 002
Ph : 011-23230910

Indian Clinical Trial & Education Network (INTENT)

EoI Announcement from ICMR

Expression of Interest (EOI) for Participation in “Indian Clinical Trial & Education Network (INTENT)”.

The Indian Council of Medical Research (ICMR) under the Department of Health Research
(DHR), Ministry of Health & Family Welfare,
Government of India, is the apex biomedical
research body in the country for formulation, co-ordination, and promotion of medical research.
The overall goal of ICMR-DHR is to generate evidence to inform policy, program and practices
pertaining to health care in India.

Clinical Studies, Trials and Projection Unit (CSTPU), Indian Council of Medical Research (ICMR),
Department of Health Research (DHR) proposes to launch the Indian Clinical Trial & Education
Network (INTENT), which will serve as a pan-India network of institutes with proven excellence
in clinical research. The network, thus established, will conduct large scale, multi-centric clinical
trials in a timely and well-regulated manner.

Why clinical trial network ?
INTENT envisages to provide evidence-based, cost effective, scientifically sound, and culturally appropriate solutions to diseases and health issues of national and/or regional importance. It will provide a single platform to conduct a range of randomized clinical trials (RCT), that will enable harmonization of trial methods, pooling of results and timely completion of the projects, along with an inclusive representation of the diverse Indian communities. Additionally, this network will be at the forefront for capacity building of a pool of health researchers across the country. The trainees will acquire requisite skills to plan and conduct RCTs and to analyse and disseminate the results that could inform policy and practice.

Structure of INTENT
INTENT will work on a hub and spoke model with a co-ordinating centre located at ICMR-DHR. Hubs will be distributed over the six regions of the country (North, South, East, West, Central and North-east) and will function as nodal point for RCTs in that region. These Advanced Centres for Clinical Trials (ACCT) will include Institutes/Medical Colleges/Hospitals of repute with rich experience and expertise related to RCTs. They will have functional linkages with Multidisciplinary Research Unit (MRU) and/or Model Rural Health Research Unit (MRHRU) under the aegis of ICMR-DHR in the region.

Each regional hub, thus identified, will act as the mentoring body for a region, with the responsibilities of supportive supervision and troubleshooting as required. They will have an inclusive expansion plan so that the newly identified potential partnering agency/institutes/organizations are inducted in the regional network. The identified MRU/MRHRU will act as a Regional Clinical Trial Unit (RCTU), responsible for daily functioning and monitoring of the trials. Each regional hub will select their study sites (spokes) as per the research question to be answered. Funding for human resource, as well as for the mentoring activities at each of these hubs will be provided by ICMR-DHR (Figure 1). The number of regional hubs will be scaled up in a phased manner. Disease-oriented domain specific networks within INTENT will be recognised according to the
domain expertise and subject specific clinical requirements.

Who can apply for Advanced Centre for Clinical Trial?
Govt. Medical Colleges/Institutes
Private Medical Colleges/Institutes
Hospitals with experience of conducting RCTs
ICMR Institutes .

Investigators motivated to lead the regional hubs can apply with institutional approval.

Criteria for selection
Investigator
a. Endorsed by the Head of the Institute/College
b. Experience of initiating/participating in multi-centric RCT
c. Good quality publications on RCTs
d. Subject specialization
e. Preferably a multi-disciplinary team of investigators to be involved, with at least 2 of the team members being mid-level faculty (associate or additional professor, or equivalent experience)

Institute
a. Community outreach programme
b. Access to potential trial participants, both in-patient and outpatients
c. History of collaboration with other institutes/medical colleges/community-based organizations
d. Catchment area catering to various geographical and population groups
e. Presence of requisite infrastructure and space

Trials to be conducted via INTENT
Research priorities of INTENT will reflect the national and/or health priorities of urgent and important nature. Among others, the areas which will be covered by INTENT are reproductive, maternal, neonatal, child and adolescent health (RMNCHA), communicable and noncommunicable diseases, nutrition, mental health, environmental health, health system research, healthcare financing, digital health, occupational health, vulnerable people’s health and oral health.

The clinical trials to be conducted by INTENT partners can be grouped as short, intermediate, and long-term projects. To begin with, the focus of the network will be on short-term projects, where questions relevant to national health needs can be answered within 1-2 years. The projects will be primarily funded by ICMR.

Interested parties should fill the Google form at the following link:
https://docs.google.com/forms/d/e/1FAIpQLSf6yt0HbP0vfJswup8q8nHRt5b1omYX8iQNWt
GEN8aSd3VjaA/viewform?usp=sf_link

The last date of receiving application: 25th October 2021

For further information, please contact:

Dr. Aparna Mukherjee
Scientist E
Clinical Studies Trials & Projection Unit
Epidemiology and Communicable Diseases Division
Indian Council of Medical Research
Email: intent.icmr@gmail.com
Mob: +919968408999

Source : https://main.icmr.nic.in/sites/default/files/upload_documents/EoI_INTENT_v1.pdf

BA BE Centres Regn Process

CDSCO Announcement – BA BE Centres to apply online for Registration Process

CDSCO to move application process for registration of centers for BA/BE studies online from Oct 15 2021

CDSCO has released a notification recently on registration process for BA/ BE Centers.

The National Drug Regulator has switched the applications for registration of bioavailability/bioequivalence (BA/BE) studies from the industry, from physical to digital from the middle of this month – 15th Oct 2021. This is in line with the Central Drugs Standard Control Organisation’s (CDSCO) efforts to implement an e-governance mechanism in the organisation.

The Drugs Controller General (India) Dr V G Somani, in a notice, said that the CDSCO, in collaboration with Centre for Development of Advanced Computing (CDAC), has developed a module for online processing of applications for registration of BA/BE study centres in accordance with New Drugs and Clinical Trial Rules, 2019.

The module is finalised and has been made functional, which can be accessed through the dedicated website of CDSCO. The drug regulatory also requested all concerned stakeholders to avail the facility and welcomed any comments or suggestions to help improve the module.

“Thereafter, the BA/BE centre registration applications processing will be online and physical applications may not be accepted after October 15, 2021, in this regard,” said the notice.

The move comes as CDSCO’s efforts to implement the e-governance mechanism with various online services launched through the Sugam portal on November 14, 2015.

On September 30, the CDSCO has said that the submission of applications on Post Approval Changes in bioavailability (BA)/bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal, in order to streamline the regulatory submission procedure.

“The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing,” said a notice, issued to all stakeholders, State and Union Territory Licensing Authorities and others.

The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.

The portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/ license, online payment, online review process, query management and grant of permission/license online. Sugam portal internally builds the database of drugs & manufacturers and their current regulatory status (approved/ banned) in India, according to C-DAC, which created the portal.

Source : http://www.pharmabiz.com/NewsDetails.aspx?aid=143001&sid=1

CDSCO Notification

Download the Notification from CDSCO here