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

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

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

Quality Champion Award

QCI Quality Champion Award – Announcement

3rd Edition – QCI Quality Champion Award – 2021-22

Quality champion award has been institutionalized by Quality Council of India with a purpose to recognize and motivate the individuals pursuing the path of Quality, Excellence for benefit of Organization associated with, society & Group/s. This Award provides a unique platform to the individuals for showcasing their significant & unique achievements and advancement in quality systems at all levels of the organization/society including recognition for their technological innovations, implementation of quality best practices for significant improvement in processes, products and services.

Quality Champion Award aims to honour outstanding individuals who have demonstrated/contributed significantly towards the Quantum (breakthrough) improvement in Quality in organisational/Social goals/objectives by

– Facilitating a quality journey
– Getting benefits to self, organization and society.
– Getting patents, publication, rewards, stakeholders appreciation within and outside the organisation
– Sustained growth of the organisation and society (business results, quality, innovation and technology)
– Upliftment of the stature of the profession.

Eligibility Criteria – Who can Apply

1. Individuals from any sector/organization from any function/department, who have demonstrated an outstanding commitment to the Quality principles through its application, management, promotion etc. to elevate Quality in any sphere(organizational/societal/social etc.) and satisfying the following:
* The applicant has direct contribution to the field of quality within India
* The applicant, through his/her work shall have a significant impact both within the organization and also towards the society and other stakeholders at large.
* The applicant has demonstrated excellence, actions, behaviours which are considered as a role model by peers and others to emulate across sectors.
2.Indian Nationals including NRI (holding Indian passport) and OCI card holders
3.Should have at least 10 years of professional experience.
4.Shall have a formal education qualification
5.Candidate should not be convicted by any court for any irregularities.
6.Candidate should also not have any investigations against them by Central/State govt. agencies of any nature

Note:

a)Following are not eligible to apply :
* QCI Employees, professionals on the payroll of QCI/its Boards and divisions
* Prevailing QCI Board/Council/Governing Body members and Committee members QCI/its constituent Boards ex. ACM, TCM members
b)Applications are accepted on self-nomination basis. Providing 2 recommendations from the field of work supporting applicant’s nomination would be advantageous

Application Fee

There is no Application Fee.

Assessment Criteria

1.Education and Skills (pertaining to Quality and other related areas including type and level of education acquired).
2.Professional Qualifications ( Methodology/tools/trainings etc. to drive organisational level change for internal/external stakeholders)
3.Working Experience : Key Professional management/leadership positions including organization wide responsibility for a major quality function(Current and key role(s) in last 10 years, including relevant projects and assignments with significant results/achievements through the application of quality related concepts/methods, impact on professional sphere ).
4.Delivery in external forum (Quality Related presentations made in national/international seminars, webinars, conferences, delegation etc.
5.Publication (Quality related articles/paper/book published).
6.Innovation in approach, Innovation in application of Quality tools and techniques, any patent(s).
7.Upgradation / development through soft intervention (demonstrated role modelling and mentoring of others, training, technical assistance, disseminating cutting edges concept of technologies)
8.Technology / digital interventions
* Application of new technologies within the organization or as a part of some project/initiative.
* Achievements on the Digitalization front through: demonstration through actual achievements – People, Product and services.
9.Benefits to the Organization(Enhancement of the processes /products, services/ quality infrastructure/building human resources driving change in the work environment , customer delight, including the horizontal deployment to other processes and units)
10.Impact on society/Quality of life/Stakeholders (brought positive change in the community/society etc.)
11.Recognition/accolades related to leadership, operations excellence, quality and performance improvement etc, peer and public recognition, any honorary title etc.

Assessment Process

1. All applications received will be initially scrutinized for completeness and adequacy of the applications.
2. Assessment team will be formed for assessment of application.
3. Shortlisted applications (after step 1) will be evaluated and scored by the assessment team as per the assessment criteria
4. Brief interaction with the shortlisted applicants (credentials, work ex, awards etc) as necessary.
5. Feedback through applicant’s customer(s)/Partner(s) from work) of the shortlisted applicants by the Assessors as per the need identified
6.The recommendation list will be reviewed by QCI Jury and the Awardees will be finalized

Terms and Condition

1. By applying for the awards, the applicant will be deemed to have read and understood the eligibility criteria and to be bound by Terms and Conditions.
2. Only online applications through the QCI Quality Champion Award web portal will be accepted
3. By applying for the awards, the applicant has agreed to allow the details of their application to be shared with the assessment panel, jury and representatives of NBQP – QCI for the purpose of administration and judging of the awards and any other purposes to which the applicant has consented.
4. In case no application qualifies for a particular award the same will not be given.
5. The names/data/scores of the applicants, the scoring system developed for the evaluation will be 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 in the public domain.
6. The Award winners will be notified via e-mail. Entries which are not shortlisted will not be notified via email or other correspondence.
7. Winners names will be announced during the Award ceremony and their names will also be listed on the Awards website and on QCI/NBQP social media channels.
8. The assessors, jury and QCI reserve the right at its absolute discretion to reject/disqualify any entry which is not accompanied by the appropriate / correct supporting documentation or any entry which is found to be inaccurate, false or misleading.
9. The jury decision will be final and no explanation, correspondence or discussion will be offered or entered into before or following the jury’s decision. Additionally, feedback will not be given on any successful or unsuccessful entry before or following the jury decision
10. No other certificate etc. shall be issued to the unsuccessful applicants.
11. By submitting application for the Award, the applicant acknowledges and gives consent on behalf of all the reference(s)/nominator(s) mentioned on his/her application for contacting them via email and/ or telephone for purpose of reference check/seeking feedback etc.
12. QCI reserves the right at its own discretion to alter or reschedule the awards and these terms at any time and without notice
13. An applicant is discouraged from influencing any officer of QCI at any stage of the Award cycle.
14. If any prospective candidates is found to be canvasing, then the application will be disqualified without any prior intimation

Timelines

Application window open till 30th Nov 2021

Guidelines For The Applicants

Template of application form and How To Apply

Where to Apply ?

https://www.qcin.org/nbqp/dsa/ChampionAward_2020/QCI/Login.aspx

QCI – D.L. SHAH Quality Awards

QCI – D.L. SHAH Quality Awards – Announcement from QCI NBQP

About the Award

Applicant organizations, who are QCI members qualify for a 10% relaxation in the application fees.

OBJECTIVE

The QCI-DL Shah Quality Awards were launched in 2007 and are positioned PAN-India as the recognition for successful projects of an organisation that have resulted in continual improvement of processes, products and/or services, better/effective operations and increased customers/stakeholders satisfaction. The awards are given for specific projects which have to be submitted in the form of case studies supported by adequate evidence in the form of documents or video clips.

AWARD CATEGORIES

There are 3 levels of the Award.These levels are:

  1. Level 1 : QCI-D.L. Shah Quality Platinum Award
  2. Level 2 : QCI-D.L. Shah Quality Gold Award
  3. Level 3 : QCI-D.L. Shah Quality Silver Award

Each level has its own distinct rigors and requirements for quality and performance with minimum qualifying marks to be achieved. During the site verification when no suitable project (case study) is found to be eligible under a sector / category, no award shall be given.

ELIGIBILITY CRITERIA

Project(s) can be from any function or department of the organization and is open to all type of organizations/sectors like :

  1. Any Govt Enterprise
  2. PSU
  3. NGO
  4. MSME
  1. Manufacturing
  2. Healthcare
  3. IT/ITes
  4. Finance
  1. Infrastructure
  2. Education
  3. Service
  4. Pharma
  1. Food
  2. Petroleum Oil,Gas
  3. Other

Sectors covered by Gol under Udyog Manthan are encouraged to apply

An organization submitting projects, shall satisfy the following conditions:

  1. The applying unit should be located in India (project(s) implemented at the sites abroad will also be considered on case to case basis).
  2. Projects should have been concluded within the last 3 years from the date of announcement of the award.
  3. Only those Projects which have concluded and have demonstrated benefits for minimum 6 months at least shall be considered.
  4. The organization shall not have been convicted by any Court for any irregularities
  5. Multiple projects applied under the same title from various units shall not be considered by virtue of implementation at other unit/plant in the horizontal deployment process.
  6. Projects applications which have been received in the past but after incorporating substantial continual and break through improvements in the process resulting in outcome(s) demonstrating quantum jumps may be considered after the period of 3 years.
  7. Projects that are entirely sub-contracted are not acceptable, however projects driven through the strategic leadership of the management and implemented with the help of outsourced facilities which are not available in-house would be acceptable (Projects shall be implemented by the applicant under the strategic plan/leadership of the management)
  8. Applications which seem to have negative influence on the human being, Quality of life, environment, Health, Safety, Society etc. will not be considered

Note:

organization can submit a maximum of 3 projects from a particular unit/branch or its regional office.

APPLICATION FEES

Organization TypeApplication Fees*
MSME/Educational/Govt/NGOINR 5000
OthersINR 10,000
Note:-
*G.S.T 18% will be applicable on application fees.
**MSMEs are required to mention their valid UAM registration number while filling up the online application form.
Applicant organizations, who are QCI members qualify for a 10% relaxation in the application fees..

Where to Apply ?

ASSESSMENT CRITERIA

Please click here to see the Detailed Evaluation Criteria

Note

1. Various sectors like large manufacturing, IT/ITes, Finance, Health Care etc. have started applying digital transformation initiatives in their respective areas. In case the organization has took any such initiative, the organization shall provide the information regarding application of new technologies or any

  1. Application of new technologies within the organization or as a part of some project/initiative example any application of Internet of Things (IOT), artificial Intelligence, Robotics etc
  2. Achievements on the Digitalization front through: demonstration through actual achievements – implementation in pipeline or ready for execution as per the roadmap/strategic plan approved by the top management on the aspects mentioned below:
    1. People : Readiness of your organization and its people to accept the changes as a consequences of the transformation including skill upgradation etc.
    2. Product/Services : The impact which digital transformation has or will have on your product(s) and services including the preparedness of the stakeholders.
    3. Process: Impact of the digital transformation on your processes/operations.

2. Such projects for which financial impact cannot be arrived at (e.g. Projects belonging to Government, Education and Social Sector etc.), financial benefits will not be considered as a parameter for evaluation. However, such projects should state the environmental, socio-economic and other benefits with reference to the assessment criteria.

ASSESSMENT PROCESS

a. Online Application

Applicants are required to submit details pertaining to the online application from (available on website)

Guidelines for Preparing project report

b. Preliminary Screening

At this stage, the NBQP Secretariat for completeness and adequacy of the application will scrutinize all the online applications

c. Document Evaluation

  1.  All filtered applications from previous step will undergo document assessment by the Assessment Team
  2. The Assessment Team will examine the case studies on the basis of the assessment criteria
  3.  Incomplete applications or such applications which lack clarity on the enablers, processes or results or are unrelated to any applications of quality tools and techniques will be rejected during this stage.
  4. The decision for cut-off marks and thereafter the selection of projects that will go for the next stage will be taken by NBQP team based on the input/feedback received from the assessment panel.

d. Project Presentation at QCI office

  1.  The aim of the project presentation is to objectively comprehend and seek clarifications from the project team that have actually executed the project. After the presentation, the Assessment Team will finally decide the marks for various criteria through consensus approach. The decision for cut-off marks and thereafter the selection of projects for which site verification are needed will be taken at the end of this phase. Organizations shortlisted after this stage will be informed about the site verification schedule well in advance

Guidelines for preparing the presentation by the Applicant organizations

e. Site Verification

The aim of site visits will be to ensure that the claims made in the project including savings as well as tools employed are verified. The Assessment team will scrutinize the necessary documents as well as interact with Top Management, Project Head & Team personnel of the organization including people involved in the project in order to satisfy that all claims are justified. The CEO/COO/VP along with Project Head shall debrief the Project and answer all the queries put up by the site assessment team.

Note :

  1.  All filtered applications from previous step will undergo document assessment by the Assessment Team
  2. The Site assessment plan will be created by QCI-NBQP with inputs from the assessors and will be informed to the organizations in advance accordingly
  3. Depending on the size of the organization, the physical site visits will be conducted by an assessment team comprising of
    1. a) 2 assessors (including 1 lead assessor) for Large organizations
    2. b) 1 assessor for small organizations
    3. c) Additionally, assessment team may have representation from QCI Team as well
  4.  The terms and conditions w.r.t physical site visit are mentioned in the respective section

f. Report Submission

The assessment team will submit a report of their assessment to NBQP Secretariat for this stage and it will include their inputs regarding their recommendations for the awards.

g. Final Selection

NBQP Secretariat will compile the results based on the cut off set and feedback received from the assessment team and share the recommendation list with the D.L. Shah Trust for the final approval on the winning projects and number of awards

GUIDELINES FOR THE APPLICANTS

Guidelines for the applicants to prepare a project report for project submission
Guidelines for preparing the presentation by the Applicant organizations

Template of application form and How To Apply

AWARD PRESENTATION

The awards will be presented during a special Award Ceremony.

TIMELINES

Application window date starts from 23rd Aug 2021 till 31st Dec 2021

TERMS AND CONDITIONS OF THE AWARDS

  1. 1. Non – disclosure and confidentiality
    1. a) 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
    2. b) QCI will not disclose the details about the shortlisted/non-shortlisted candidates at any stage of the assessment. The qualified projects will be notified via e-mail/call by the QCI office directly. 
  2. 2. Any misinterpretation of facts will disqualify the organization from Awards and fees would be non- refundable
  3. 3. Applications will be considered only if the eligibility criteria are satisfied
  4. 4. Incomplete applications or such applications which lack clarity on the enablers, processes or results or are unrelated to any applications of quality tools and techniques will be rejected.
  5. 5. Project Site: only initial site where the project has been implemented will be considered, rest locations will only be considered as a case of replication. Successful applicants will receive the trophy/certificate only for the location against which they submitted the application
  6. 6. No changes in the project application (title, location etc.) will be accepted after the final submission
  7. 7. Application Fees towards submission of the project(s) is non-refundable/ non- adjustable
  8. 8. Any Quality Award applicant and Awardee cannot use the NBQP, QCI and D.L. Shah Trust logo in any way that suggests that QCI is affiliated with, sponsors, approves or endorses them, their organization/websites/products/services etc
  9. 9. QCI and D.L. Shah Trust reserves all the rights to final selection of the Awardee(s). No appeal or protest in this regard would be entertained.
  10. 10. If no outstanding entries have been received, no award will be awarded for the year
  11. 11. In case of Physical Site Visits, following conditions will be applicable

Cost to be borne by the applicant organization 
Besides the requisite application fees for participating in the Award the following costs are to be borne by the applicant organization.

  1. For Presentation round: All costs incurred by the Team Members of various projects who would be making presentation before assessment team members atQuality Council of India office, New Delhi.
  2. For Site verification 
    1. a) All incidental expenses from the residence of the assessment team/Head Office at Delhi will be borne by the applicant organization based on the consolidatedclaim raised by QCI.
    2. b) Airfare charges* (wherever there is air connectivity)/train/AC Sedan car (in case no air/train connectivity exists) 
    3. c) Hotel stay including Food/travel and other miscellaneous expenses.

Note: –

  1. Depending on the size of the organization, the Assessment team members(as stated in section” Assessment Process-Site verification ) and man-days would vary from 1-2 days, so the hotel and travel expenses will vary accordingly
  2. In case the assessment is carried forwarded to the 2nd day, then the stay expenses shall be borne by the applicant organization for the 2nd night as well 

CONTACT POINT

Ms. Shruti Gupta              Administrative Officer|NBQP   Mail at : shruti.nbqp@qcin.org         8800891834

Ms. Priyanka Maithani    Assistant Director|NBQP          Mail at : priyanka.nbqp@qcin.org    8178602471

Source : https://www.qcin.org/nbqp/dsa/home/Home.aspx

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

FAQs Session With CDSCO

Medical Device Regulations – Non Notified Devices – Voluntary Registration ProcessSeptember 19th 2021, Sunday – 4 PM – 5 PM

Let Our REGULATOR Speak to You !

Do Join Us to get answers to your FAQs on Voluntary Registration Process !

Voluntary Registration Process rolled out by CDSCO for Non Notified Devices is coming to an end by Sep 30th 2021. Industry Forums are receiving so many FAQs from various stakeholders over the last 2 months asking many questions on Voluntary Registration Process and raising wide range of questions on WHAT HAPPENS FROM OCTOBER 1ST 2021.

Hence AIMED (Association of Indian Medical Device Industry) is organising a session to enable the industry, stakeholders to get their FAQs addressed from the Regulator.

Some of the FAQs raised by stakeholders are captured below and we invite industry, stakeholders to register and join the session to discuss pertinent issues , challenges faced, if any.

This program is the initiative of AIMED , a leading Industry Platform for Make in India Manufacturers representing the Voice of the Industry.

Program Information :

Some FAQs from Industry which need information from CDSCO :

Registration Details :

Who Should Attend ?

Program is Open for all Industry Members, Stakeholders like Manufacturers, Traders, Distributors, Startups, Med Tech Businesses etc.

There is NO REGISTRATION FEE but Prior Registration is a MUST.

Registered Participants shall get Email Confirmation 2 days before the session from Consultants Consortium of Chennai .

Registration Link

Download the program collaterals from here

Contact Co-ordinates :

Ms Rama Venugopal
Email – contact@ccc-consultants.org
WhatsApp – +91 9840870532

Mr D Srikanthan
Email – secretariat@ccc-consultants.org
WhatsApp – +91 9003056539

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

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