Description

Associate - Regulatory Affairs and Intellectual Property prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM -05-LS-00252-2023-V1.1-LSSSDC LFS/Q0501-SI001 5 II 630 21 B. Tech Final Year Student (in Relevant Field) OR B. Pharma final year student OR M. Sc (with relevant Subjects) Final Year Student 990(mandatory)

Theory

Practical

ES

210 330 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

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Download

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Description

Associate - Regulatory Affairs and Intellectual Property prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM -05-LS-00252-2023-V1.1-LSSSDC LFS/Q0501-SI002 5 II 630 21 B. Tech Final Year Student (in Relevant Field) OR B. Pharma final year student OR M. Sc (with relevant Subjects) Final Year Student 990(mandatory)

Theory

Practical

ES

210 330 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate - Regulatory Affairs and Intellectual Property prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM -05-LS-00252-2023-V1.1-LSSSDC LFS/Q0501-SI003 5 II 630 21 B. Tech Final Year Student (in Relevant Field) OR B. Pharma final year student OR M. Sc (with relevant Subjects) Final Year Student 990(mandatory)

Theory

Practical

ES

210 330 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate - Regulatory Affairs and Intellectual Property prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM -05-LS-00252-2023-V1.1-LSSSDC LFS/Q0501-SI004 5 II 690 23 B. Tech Final Year Student (in
 Relevant Field)
 OR
 B. Pharma final year student
 OR
 M. Sc (with relevant Subjects)
 Final Year Student
990(mandatory)

Theory

Practical

ES

240 360 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate - Regulatory Affairs and Intellectual Property prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM -05-LS-00252-2023-V1.1-LSSSDC LFS/Q0501-SI005 5 II 690 23 B. Tech Final Year Student (in
 Relevant Field)
 OR
 B. Pharma final year student
 OR
 M. Sc (with relevant Subjects)
 Final Year Student
990(mandatory)

Theory

Practical

ES

240 360 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

The Lab Technician-Research and Quality Control performs the processing of glassware for experimentation. The job holder is responsible for storage, handling chemical reagents / solutions and preparation of stock solutions for smooth execution of experiments and tests. They also provide all the required assistance to analysts and researchers in ensuring that laboratory activities are carried out in adherence with procedures laid in Good Manufacturing / Laboratory / Clinical Practices. The individual also assists lab in-charge in complying with WHO, NABL and other environmental, health and safety guidelines.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-03-LS-00261-2023-V1.1-LSSSDC LFS/Q0509-SI001 3 I 315   B. Pharma 7th Semester or B. Tech (Biotechnology/Biochemical/ Chemical Engineering) 3rd year or M.Sc. (Biotechnology/ Life Sciences) 12 Months

Theory

Practical

ES

95 190 30
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

The Lab Technician-Research and Quality Control performs the processing of glassware for experimentation. The job holder is responsible for storage, handling chemical reagents / solutions and preparation of stock solutions for smooth execution of experiments and tests. They also provide all the required assistance to analysts and researchers in ensuring that laboratory activities are carried out in adherence with procedures laid in Good Manufacturing / Laboratory / Clinical Practices. The individual also assists lab in-charge in complying with WHO, NABL and other environmental, health and safety guidelines.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-03-LS-00261-2023-V1.1-LSSSDC LFS/Q0509-SI002 3 I 315   B. Pharma 7th Semester or B. Tech (Biotechnology/Biochemical/ Chemical Engineering) 3rd year or M.Sc. (Biotechnology/ Life Sciences) 12 Months

Theory

Practical

ES

95 190 30
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate - Regulatory Affairs and Intellectual Property (IVD and Medical Devices) prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00253-2023-V1.1-LSSSDC LFS/Q0513 5 II 660 22 B. Tech Final Year Student (in Relevant Field)
 OR
 B. Pharma final year student
 OR
 M. Sc (with relevant Subjects) Final Year Student
990(recommended)

Theory

Practical

ES

210 360 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate - Regulatory Affairs and Intellectual Property (IVD and Medical Devices) prepares dossiers to support appropriate licensing, marketing and legal compliance of products and ensure products comply with current regulations. The job role holder carries out proper documentation and reporting for dossier preparation and assist in intellectual property management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QM-05-LS-00253-2023-V1.1-LSSSDC LFS/Q0513-SI001 5 II 600 20 B. Tech Final Year Student (in Relevant Field)
 OR
 B. Pharma final year student
 OR
 M. Sc (with relevant Subjects) Final Year Student
990(recommended)

Theory

Practical

ES

180 330 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI001 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI002 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI003 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI004 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI005 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI006 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Research Associate - Pharma and Biological Products is responsible for assisting in biological product development, API synthesis, medicinal chemistry-based research, carrying out research related activities along with also assists in technology transfer and process development activities to large scale manufacturing. The jobholder is also responsible for reporting and documentation, problem solving and decision-making, Co-ordinate with manager and team members and maintaining healthy and safe working environment.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00997-2023-V1-LSSSDC LFS/Q0514-SI007 5.5 I 540 18 Pursuing Final Year of postgraduation -M Sc. In relevant science field OR Pursuing Final Year of postgraduation -M. Pharma OR Pursuing Final Year of postgraduation-M.Tech in relevant Engineering domain 990 recommended

Theory

Practical

ES

180 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate-Clinical Research Management (Pharma, Biologics and Medical devices Facility) supports clinical trial activities, carries out reporting and documentation for monitoring of research activities to ensure regulatory compliance and current Good Clinical Practices (cGLP) as per ICH and coordinates with site staff members, investigators, Site Management Organization and Sponsor. The role holder is expected to assist in the Biostatistics analysis of clinical trial data with the help of artificial intelligence.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00251-2025-V2-LSSSDC LFS/Q3501-SI001 5.5 II 570 19 Completed 3rd year of 3-year/ 4-years UG in Biology, Nursing, Medical Lab Technician, Life Sciences, Biotechnology
OR
Completed 3rd year of B.E/ B. tech. Biotech
Or    
Completed 3rd year B. Pharma    
OR
BAMS/ BDS/ BUMS/ BHMS/ MBBS
6 Months

Theory

Practical

ES

180 300 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate-Clinical Research Management (Pharma, Biologics and Medical devices Facility) supports clinical trial activities, carries out reporting and documentation for monitoring of research activities to ensure regulatory compliance and current Good Clinical Practices (cGLP) as per ICH and coordinates with site staff members, investigators, Site Management Organization and Sponsor. The role holder is expected to assist in the Biostatistics analysis of clinical trial data with the help of artificial intelligence.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00251-2025-V2-LSSSDC LFS/Q3501-SI002 5.5 II 570 19 Completed 3rd year of 3-year/ 4-years UG in Biology, Nursing, Medical Lab Technician, Life Sciences, Biotechnology
OR
Completed 3rd year of B.E/ B. tech. Biotech
Or    
Completed 3rd year B. Pharma    
OR
BAMS/ BDS/ BUMS/ BHMS/ MBBS
6 Months

Theory

Practical

ES

180 300 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate-Clinical Research Management (Pharma, Biologics and Medical devices Facility) supports clinical trial activities, carries out reporting and documentation for monitoring of research activities to ensure regulatory compliance and current Good Clinical Practices (cGLP) as per ICH and coordinates with site staff members, investigators, Site Management Organization and Sponsor. The role holder is expected to assist in the Biostatistics analysis of clinical trial data with the help of artificial intelligence.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00251-2025-V2-LSSSDC LFS/Q3501-SI004 5.5 II 570 19 Completed 3rd year of 3-year/ 4-years UG in Biology, Completed 3rd year of 3-year/ 4-years UG in Biology, Nursing, Medical Lab Technician, Life Sciences, Biotechnology
OR
Completed 3rd year of B.E/ B. tech. Biotech
Or    
Completed 3rd year B. Pharma    
OR
BAMS/ BDS/ BUMS/ BHMS/ MBBS
6 Months

Theory

Practical

ES

220 260 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

Associate-Clinical Research Management (Pharma, Biologics and Medical devices Facility) supports clinical trial activities, carries out reporting and documentation for monitoring of research activities to ensure regulatory compliance and current Good Clinical Practices (cGLP) as per ICH and coordinates with site staff members, investigators, Site Management Organization and Sponsor. The role holder is expected to assist in the Biostatistics analysis of clinical trial data with the help of artificial intelligence.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-00251-2025-V2-LSSSDC LFS/Q3501-SI003 5.5 II 570 19 Completed 3rd year of 3-year/ 4-years UG in Biology, Nursing, Medical Lab Technician, Life Sciences, Biotechnology
OR
Completed 3rd year of B.E/ B. tech. Biotech
Or    
Completed 3rd year B. Pharma    
OR
BAMS/ BDS/ BUMS/ BHMS/ MBBS
6 Months

Theory

Practical

ES

210 270 90
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

The Lab Technician-Pharma, Biologics and Medical devices performs the processing of glassware for experimentation. The job holder is responsible for storage, handling chemical reagents/solutions and preparation of stock solutions for smooth execution of experiments and tests. They also provide all the required assistance to analysts and researchers in ensuring that laboratory activities are carried out in adherence with procedures laid in current Good Manufacturing/ Laboratory/ Clinical Practices. The individual also assists lab in-charge in complying with WHO, NABL and other environmental, health and safety guidelines.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-3.5-LS-03405-2024-V2-LSSSDC LFS/Q0509-SI001 3.5 I 360 12 11 grade pass 
Or 
10th Grade pass with 1.5 Year of Experience In Lifesciences sector
6 Months

Theory

Practical

ES

110 220 30
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

The Lab Technician-Pharma, Biologics and Medical devices performs the processing of glassware for experimentation. The job holder is responsible for storage, handling chemical reagents/solutions and preparation of stock solutions for smooth execution of experiments and tests. They also provide all the required assistance to analysts and researchers in ensuring that laboratory activities are carried out in adherence with procedures laid in current Good Manufacturing/ Laboratory/ Clinical Practices. The individual also assists lab in-charge in complying with WHO, NABL and other environmental, health and safety guidelines.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-3.5-LS-03405-2024-V2-LSSSDC LFS/Q0509-SI002 3.5 I 360 12 11 grade pass 
Or 
10th Grade pass with 1.5 Year of Experience In Lifesciences sector
6 Months

Theory

Practical

ES

110 220 30
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

This NOS on Pharmacovigilance Case Processing for Incidents/adverse event using software including AI tools will enable individual of adverse event processing, software tools, and advanced AI applications in drug safety. Participants will gain a comprehensive understanding of pharmacovigilance's role in ensuring drug safety and the potential benefits and ethical considerations of AI integration. Regulatory compliance, data source analysis, and the practical application of AI tools are emphasized throughout the course. By the end, participants will be equipped to navigate the evolving field of pharmacovigilance with a strong focus on AI's pivotal role in ensuring drug safety, efficiency, and compliance.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NG-5.5-LS-01295-2023-V1-LSSSDC LFS/N0707 5.5 II 60 2 Pursuing Final Year of B.Sc (Microbiology) / B. Pharma / B. Tech (Biotech) (Indian / foreign universities) 
 OR
 Pursuing Final Year of MBBS/BDS/BPT/BOT/BAMS/BHMS (in any medical subject)/ (Indian / recognized foreign universities)
6 Months

Theory

Practical

ES

30 30  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

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Description

This NOS on Aggregate Report writing for Regulatory Compliance will enable individual to have the capability to independently draft comprehensive Aggregate Reports that adhere to strict regulatory compliance standards, ensuring the accurate and timely submission of critical pharmacovigilance data, and demonstrating proficiency in the application of industry-specific best practices for report writing.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NG-5.5-LS-01296-2023-V1-LSSSDC LFS/N0708 5.5 II 60 2 Pursuing Final Year of B.Sc (Microbiology) / B. Pharma / B. Tech (Biotech) (Indian / foreign universities) 
 OR
 Pursuing Final Year of MBBS/BDS/BPT/BOT/BAMS/BHMS (in any medical subject)/ (Indian / recognized foreign universities)
6 Months

Theory

Practical

ES

30 30  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

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Download

Description

Analyst- Drug Safety/ Pharmacovigilance is responsible for the collection of information on ADR/AE and processing of Individual Case Safety Reports (ICSR). The individual is responsible for preparation and submission of Periodic Safety Reports Like PSUR, PBRER, DUSR etc. The person is also expected to render support in development of Risk Management Plan (RMP) and Pharmacovigilance System Master File (PSMF). The individual is also responsible for Global and local Literature Surveillance using literature databases (e.g. PubMed, Embase).This individual is involved in Processing , maintenance and safety of sensitive personal information in compliance with local regulations and company’s Global Pharmacovigilance requirements. The individual is responsible for permanent organized documented records of for all safety reports
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

QG-5.5-LS-01267-2023-V1-LSSSDC LFS/Q0701 5.5 II 540 18 Completed B.Sc (Microbiology) / B. Pharma / B. Tech (Biotech) (Indian / foreign universities) 
 OR
 Completed MBBS/BDS/BPT/BOT/BAMS/BHMS (in any medical subject)/ (Indian / recognized foreign universities)
6 Months

Theory

Practical

ES

210 270 60
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

Download

Download

Download

Description

The professional with Basics of Clinical Data Management have foundational knowledge and skills in the field of clinical data management (CDM). This includes understanding of the importance of CDM in clinical research, learn key terminology and concepts, explore data sources in clinical trials, delve into the design of case report forms (CRFs), and understand the critical processes of data entry, cleaning, and quality assurance in CDM. The professional with Basics of Clinical Data Management has good knowledge of regulatory guidelines and data privacy regulations that impact CDM practices
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NM-05-LS-01298-2023-V1-LSSSDC LFS/MCr-0009 5 II 15 0.5 Pursuing 2nd-year of Graduation Degree in relevant Field and continuous education
 Or
 Pursuing 2nd year of 2-year Diploma (after 12th Class) in relevant field
6 Months

Theory

Practical

ES

12 3  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

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Description

The individual with Advanced Data Capture Techniques in Clinical Data Management is able to perform cutting-edge data capture techniques within the field of clinical data management. This includes Electronic Data Capture (EDC) systems, mobile health (mHealth) data collection, remote patient monitoring (RPM), electronic patient-reported outcomes (ePRO), and the integration of real-world data (RWD) into clinical databases. The professional with Advanced Data Capture Techniques in Clinical Data Management is prepared for roles demanding in-depth theoretical understanding, specialized technical proficiency, and the ability to make informed decisions in the dynamic field of clinical data management.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NM-05-LS-01299-2023-V1-LSSSDC LFS/MCr-0010 5 II 30 1 Pursuing 2nd-year of Graduation Degree in relevant Field and continuous education
 Or
 Pursuing 2nd year of 2-year Diploma (after 12th Class) in relevant field
 

Theory

Practical

ES

20 10  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

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Description

The individual with Clinical Data Reporting and Analysis skills is able to support in Clinical Data Management (CDM). This includes data analysis, safety and efficacy reporting, Clinical Study Reports (CSRs) compilation, advanced data visualization, and meta-analysis. The professional with Clinical Data Reporting and Analysis skills is proficient in ensuring data quality and compliance, making them indispensable in the healthcare and pharmaceutical sectors, where they contribute to informed decision-making and effective communication of research findings.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NM-5.5-LS-01300-2023-V1-LSSSDC LFS/MCr-0011 5.5 II 30 1 Pursuing 3rd year of Graduation Degree in relevant Field and continuous education 6 Months

Theory

Practical

ES

20 10  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

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Description

The Individual with Clinical Data Validation and Quality Control Skills is able to ensuring the accuracy and reliability of clinical data in clinical research industry. This includes data validation principles, database locking, query management, data reconciliation, and quality control measures in Clinical Data Management (CDM). The professional with Clinical Data Validation and Quality Control has knowledge to manage discrepancies, uphold data integrity, and make informed decisions critical to the success of clinical trials and studies.
 

NQR Code

QP Code

NSQF Level

CCN Category

Total Duration

Credits

Eligibility Criteria

Apprenticeship Duration

NM-5.5-LS-01301-2023-V1-LSSSDC LFS/MCr-0012 5.5 II 30 1 Pursuing 3rd year of Graduation Degree in relevant Field and continuous education 6 Months

Theory

Practical

ES

20 10  
 

Qualification Pack

Model Curriculum

Trainer Qualification

Lab Specification

Equipment List

Facilitator Handbook

Participant Handbook

Sample Question Bank

Download

Download

Download

Download

Download

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