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 :

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

Laboratory Excellence Award

Prof. S.K. Joshi Laboratory Excellence Award from QCI NBQP

Prof. S.K. Joshi – Laboratory Excellence Award has been instituted to promote Laboratory Quality and performance improvement in the country. The award has been incepted to ensure the laboratory’s commitment to achieve excellence in providing high precision testing and calibration services in line with the prevalent national/international quality systems legislations including Health, Safety, Environment (HSE).

The Award is to recognize Laboratories (Testing, Medical and Calibration) those have established outstanding achievements in the field of Quality in services and benchmarked in their domain for their best practices

Eligibility:

1.This award is open to all currently operational Laboratories pertaining to Testing, Calibration & Medical including their Proficiency Testing Providers & Reference Material Producers located in India.
2.Participating labs are required to operate the applicable Quality System according to the requirements as stipulated in ISO 17025/ISO 15189/ISO 17043/ISO 17034, regarding its implementation and monitoring.
3. The award require labs to operate with proper HSE measures.
4.The Laboratory should not have been convicted by any Court.
5.A Laboratory once awarded can be considered only after a period of 3 Years

The 5 stages of assessment by Technical Expert Committee (TEC) are as follows:-

Stage 1: Application Document Evaluation
Stage 2: Physical/Virtual Presentation
Stage 3: Site Assessment / verification
Stage 4: Evaluation through Reference check of customer in special case
Stage 5: Inputs to Jury for final evaluation

Assessment Criteria

The assessment of the application submitted by the laboratory is made on the basis of various parameters which have been identified by a team of experts from NBQP/QCI.

Primary Parameters:

  1. Management Commitment – Qualification, Experience, Training & Innovation, Quality Improvement and skill upgradation.
  2. Strategy – Accreditation for entire Laboratory activities (to ensure Sustainability).
  3. Processes – Standard Method (National/International), Validation/Verification, Equipment/Techniques used and Measurement Traceability to SI units.
  4. Infrastructure & Quality Control Resources – Facilities and Environmental Conditions (Innovation for enhancing Good Laboratories Practices) owned by Lab. Use of Certified Reference material, Proficiency Testing Program participation and Inter-Laboratory Comparison and other QC checks.
  5. Customer Complaints, Feedback and Improvement – Diagnosis of the problem (Root Cause Analysis & Quality tools deployed)
  6. Key Results/Satisfaction – Reports, Customer Results, Society Results and Employee Satisfaction. Tangible benefits, intangible benefits or socio economic and environmental benefits

Terms & Conditions Of The Award:

1. Non – disclosure and confidentiality
I. The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed.
II. QCI will not disclose the details about the shortlisted/non-shortlisted laboratories at any stage of the assessment. The qualified laboratories will be notified via e-mail/call by the QCI office directly.
2. Any misinterpretation of facts will disqualify the laboratories from Awards.
3. Applications received with incomplete data will not qualify.
4. Any Award applicant and Awardee cannot use the NBQP and QCI logo in anyway that suggests that QCI is affiliated with, sponsors, approves or endorses you, your organization, your websites, your products or your services etc.

Application Fees

There is no Application Fees

Award Presenatation

The awards will be presented during a special Award Ceremony

Where to Apply ?

Award Details

check here to know more about various awards and details

When is the Last date for applying ?

Last date for submitting the application form is 16th November 2021

For any queries, contact :

Source – https://labexcellenceaward.qcin.org/Home.aspx

Fee Update from NABL

Revised Fee Structure effective for all applications received on/after 01.10.2021 Posted on 01.10.2021

NABL has released revised Fee Structure for all applications received on or after 1/10/2021 . This is applicable for all Testing and Calibration Labs.

All applicant labs and Accredited, Certified Labs have to make a note of the same.

Download the notification from here .

Medical Device QMS

NABCB Program on MDQMS – Medical Device Quality Management Systems

Program Announcement from NABCB !

NABCB is organising series of webinars on “Medical Devices Quality Management Systems (MDQMS) and Indian Certification for Medical Devices (ICMED) Scheme”

There is no fee for the said Webinar. The Webinar is scheduled on 20 October 2021 at 11:00AM – 01:00 PM (IST)

This webinar would provide an interface wherein you may directly interact with NABCB Officials about NABCB Accreditation system and other requirements, so your participation would make the webinar interesting and fruitful.

Registration link is https://forms.gle/Qg2Z55iYc6oNWKnv7

The flyer is available on link  http://nabcb.qci.org.in/Meeting%20%20flyer%20-%20MDQMS%20%20ICMED-%2020%20October%202021.pdf

Meeting Link shall be provided to all the registered participants a day before the scheduled date.

Contact NABCB Secretariat :
National Accreditation Board for Certification Bodies
Quality Council of India | www.qcin.org
Institution of Engineers Building, 2nd Floor,
2, Bahadur Shah Zafar Marg, New Delhi – 110002, India
Work: +91-11-2337-9321 | Fax: +91-11-2337-8678
Facebook | Linked In Twitter

Good Clinical Practices Training

Awareness Programme For Training Institutions on Good
Clinical Practice Professional Certification Scheme (GCPPCS)

About CDSA

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.

About GCPPCS

There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. Setting up an uniform system to achieve the desired competence standard using internationally accepted best practice for ‘Assessment’ and ‘Certification’ is the key to addressing this unmet need.

To this end, a Certification Scheme for GCP professionals based on the International ‘Personnel Certification’ standard (ISO 17024:2012) has been developed by CDSA-THSTI.

The GCP professional certification scheme has  two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and  GCP Professionals Certification (by Third-Party Certification) to promote certification of professionals both within the country and across the globe.

GCPPCS is owned by the Clinical Development Services Agency (CDSA)-Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSA-THSTI as Scheme Owner,  has the Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents and  effective implementation of the Scheme.  These committees are comprised of multiple stakeholders for example subject and process experts with representatives from ministries, regulator, government agencies, industry, academia, accreditation body, certification body, training institutions and civil society organisations.

Upcoming Program on GCPPCS :

CDSA has successfully completed two webinars for creating awareness and generating interest amongst the Personnel Certification Bodies, Training Institutions and individual GCP professionals for the Good Clinical Practice Professional Certification Scheme (GCPPCS) on September 22 and October 6, 2021.

The next webinar, specifically designed for the Training Institutions, is scheduled for October 20, 2021 from 1400 hrs. Prof Y K Gupta would be delivering the Opening Remarks.

S.NO.DATESPEAKERTOPICRELATED MATERIALREGISTRATION LINK
1October 20,2021Prof. Debjani Roy
Dr. Harish Nadkarni Maheshwari
Dr. Sanish Davis
Dr. Sucheta Banerjee Kurundkar
Mr. S Krishnamurthy
Prof. Y.K Gupta
Awareness Programme For Training Institutions on GCPPCSProgram FlyerRegistration deadline: October 18, 2021

Registration Form

CDSA invites participation from Healthcare Services Sector to explore opportunities to be the Training Partners for this program. Attending this webinar will throw more light about the GCPPCS Program.

For further information, please contact us at gcppcs.cdsa@thsti.res.in 

प्रो. देबजानी रॉय/Prof. Debjani Roy
सदस्य सचिव और कार्यक्रम प्रबंधक, जीसीपीपीसीएस /Member Secretary & Program Manager, GCPPCS – Clinical Development Services Agency Translational Health Science & Technology Institute, 
Department of Biotechnology, Ministry of Science & Technology, Government of India
NCR Biotech Science Cluster, 3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121001
क्लिनिकल डेवलोपमेंट सर्विसेस एजेंसी, ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट,
विज्ञान और प्रौद्योगिकी मंत्रालय, भारत सरकार
Tel: +91-41052296,
Email: debjaniroy.cdsa@thsti.res.ingcppcs.cdsa@thsti.res.in

OKRs Focus in Businesses

Webinar on OKRs – Growth Strategy for your Business Sep 17th 2021 – Friday – 3PM – 4PM

“Ideas are Easy. Execution is Everything” – John Doerr

How OKRs help 1000s of companies accelerate growth

O – Objectives
K – Key
R – Results

What is OKR ?

Objectives and Key Results (OKR) are a goal-setting framework that helps organizations define goals — or objectives — and then track the outcome.

OKR is a concept widely accepted in the digital landscape as well as offline market to inspire and motivate their employees. It answers the major questions like:

  • Where do I want to go?
  • How do I pace myself to see if I am getting there?

OKRs provide organizational focus to teams and help in drastically improving productivity.

Download a brief note on OKR to understand a little about the same :

Session Focus

How to introduce OKRs for your Organization?
– A Case Study Presentation

Target Audience

CXOs / Founders / Chief of Staff / Strategy Leaders

Program Agenda

Speaker Session – 40 minutes
Q & A – 20 minutes

Webinar Outcome

  • What are OKRs ?
  • Why are OKRs being adopted by CXOs globally?
  • A case study presentation – An OKRs implementation story

Registration

No Registration Fee but prior registration is a must.

Registered Participants shall get confirmation mail 2 days before the program.

Registration Link :

Contact Co-ordinate

D C Sriram
RVK Business Advisory Services P Ltd
Email – contact@virtualadvisor.in
WA – +91 9150061418

Download Program Brochure

Virtual Advisor on Social Media

https://www.youtube.com/channel/UC5_HedmdImYZ-9hxgv27LYg/featured

https://www.facebook.com/glocaladvisor

Clarification on the Role of NABL in Enforcing Regulations

Announcement from NABL – National Accreditation Board for Testing and Calibration Laboratories

Clarification on the Role of NABL in Enforcing Regulations

Accreditation is the independent evaluation of Conformity Assessment bodies against recognised normative documents like Standards, Regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence. Through the application of national and international Standards, Government, Procurers and Consumers can have confidence in the results of accredited Conformity Assessment Bodies.

Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to Medical Laboratories.

Laboratory Customers, Regulatory Authorities, Organizations and Schemes using peer assessment, Accreditation bodies, and others use these documents in confirming or recognizing the competence of laboratories.

The results from Accredited Laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.

Many Government Agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards.

NABL Accreditation is increasingly being used by Regulators and Government to ascertain the Quality of Products. Accredited CABs can objectively state conformance of product or service to specified requirements.

NABL is a Voluntary Accreditation body and has no Regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable Regulator.

In all cases, it is the responsibility of Laboratory to abide by the National & State Statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions/ Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time.

Download the announceement from here

Source : https://nabl-india.org/

The above announcement from NABL clarifies its role as Accreditation body to various stakeholders at market place. Regulators , Governments normally rely on Accreditation Bodies for Conformity Assessment procedures. Accreditation bodies are not Regulators and can’t step into shoes of Regulators. This confusion is often seen at market place where Accreditation bodies and Regulators Roles are understood wrongly , get mixed up often. Frequent communication from Apex bodies , Accreditation bodies clarifying the role of ABs, CBs etc throws so much clarity to the industry, stakeholders too. Markets still mix up Accreditations and Certifications. Lot of confusion prevails between Voluntary Recognition Programs and Mandatory Recognition Programs. FAQs list is very long and apex bodies can release communication often on all the FAQs.

Improving Global Competitiveness of Indian businesses is the key focus of Govt of India and businesses need to show compliance to various Conformity Assessment Procedures of Importing Countries. Understanding all these matter as most of these protocols are International Protocols too.

Country is witnessing lot of FDI and many new global businesses are setting up shop in India. International businesses need clarity and clear communication on conformity assessment too as Technical Regulations are linked to International Accounting Standards as well.