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

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 :

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

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 .

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