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Businessmen

Best Pharmacovigilance Training Institutes in India

Company Connect Consultancy

Combo of PV, CDMS, CR & Medical Writing Training Course

Company Connect Consultancy is Providing Integrated industrial Course for Pharmacovigilance, Clinnical Data Management, Clinical Research and Clinical Trial & Medical Writing with very affordable price. In this course all the topics of PV, CDMS, CR and Medical writing will be covered in 3 month time period. 

Pharmacovigilance Topics to be covered

  • Module 1: Introduction to Pharmacology, Clinical Trials and Pharmacovigilance

  • Module 2: Adverse Drug Reactions and Safety Reports

  • Module 3: Methodologies in Pharmacovigilance

  • Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance (Argus, ArisG, MedWatch, MedRA, WHODD etc.)

  • Module 5: Seriousness & Expectedness & Causality Assessment Criteria

  • Module 6: Aggregate Safety Reports

  • Module 7: Pharmacovigilance Regulations in Various Countries

  • Module 8: Pharmacovigilance Programme in India (PVPI)

  • Module 9: Signal Detection and Data Mining

  • Module 10: Pharmacovigilance of Herbal Drugs & Medical Devices

  • Module 11: Pharmacovigilance Compliance and Inspections

  • Module 12: Hands-on training on Argus, ArisGlobal, ABcube etc software platforms.

  • Module 13: Case Study

Brief of topics to be cover in Training course 

1.     Welcome and Introduction, History & Overview of Pharmacovigilance

2.     Drug Development and Clinical Trial Phases

3.     Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.

4.     Pharmacovigilance Process & Life cycle

5.     Introduction and responsibilities: USFDA, EMA and CDSCO

6.     Pharmacovigilance in India

7.     Clinical Development process

8.     Different phases of clinical Trials

9.     Adverse events and its types

10.  Drug Safety in clinical trials and post marketed drugs

11.  Different sources of Adverse events reporting

12.  Different types of AE reporting Forms

13.  Expedited reporting and its timelines

14.  Different departments working on Pharmacovigilance

15.  Roles and responsibilities of case receipt unit

16.  Roles and responsibilities of Triage unit

17.  Four factors for the reportable case

18.  Seriousness criteria of adverse event

19.  Expectedness or Listedness of adverse event

20.  Causality assessment of the adverse event

21.  Introduction to  safety database and different types

22.  Narrative writing

23.  Case quality check, Medical review and its submission.

24.  The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area

25.  PSUR and its submission timelines

26.  Regulatory Authority in Pharmacovigilance

27.  ICH GCP Guideline

CDMS Topics to be covered

  • Module 1.Clinical Trail Process and Design

  • Module 2.ICH-GCP and GCDMP

  • Module 3.Clinical Data Management Systems

  1. CRF Design

  2. Data Entry & Data Collection

  3. Data Load/Transfer

  4. Data Storage

  5. Data Validation

  6. Data Export (SDTM)

  7. Query Management

  8. Data Archiving

  9. Quality Systems,SOPs and Audits

  10. Safety Management and Pharmacovigilance

  11. Data Management Systems and Tools

  12. Medical Codings and Medical Dictionaries

  13. CDMS, AERS,EDC,OCTMS

  14. Documentation and Document Management System

  • Module 4.Statistical Analysis (analytical Tools) and Reporting

  • Module 5.Project Management

  • Module 6.Security Systems

Clinical Research and Clinical Trials Topics to be covered

  • Introduction to Clinical Research Industry and Basics of Clinical Trials

  • Drug Discovery & Development Process

  • Pre-clinical studiesPre-clinical studies

  • Basics of Clinical Trials & Clinical Research

  • Terminology & Definitions in Clinical Trials

  • Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP): ICH Good Clinical Practice E6 (R2)

  • Indian GCP and Schedule Y

  • Types and Phases of Clinical Trials

  • BA/BE Studies

  • Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

  • Research Methodology & Clinical Trial Design

  • Essential Documents in Clinical Trials: Protocol, CRF, Inform Consent, Investigator's Brochure, Study Progress Report

  • Responsibilities of Clinical Research Professionals

  • 21 CFR PART 11

  • Clinical Data Management

  • Pharmacovigilance in India, US & UK

  • Medical Coding (MedDRA & WhoDrug)

  • Medical Writing

  • Informed Consent Document

  • Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019

  • Intellectual property Rights (IPR) and Patent Laws

  • Industry Based Case Studies

Medical Writing Topics to be covered

  • Module 1.Security Systems

  • Module 2.What is Medical Writing

  • Module 3.Scope of Medical Writing

  • Module 4.Medical Writing in Clinical Trial

  • Module 5.Medical Writing & Scientific Writing

  • Module 6.Fundamentals of Medical Writing

  • Module 7.Marketing Medical Writing

  • Module 8.Regulatory Medical Writing

  • Module 9.The Writing Process

  • Module 10.Good Writing Skills

    • Introduction to basic rules

    • Elements of style

    • Grammar and good writing

  • Module 11.Good Clinical Practice Guidelines

  • Module 12.The Clinical Study Report

  • Module 13.Introduction to Publication Writing

  • Module 14.Regulations and Industry Standards

  • Module 15.Writing Effective Documents

    • Writing Standard Operating Procedures Policies, Procedures, Instructions, and Methods

    • Writing Quality Manuals and Plans

Practical Training will be also provided on Oracle Argus Safety Database on the following topics:

  • Case processing

  • MeDRA coding & WHO DD coding

  • Duplicate Check and case initiation

  • SAE Narrative writing

Benefits of Courses from Company Connect Consultancy

  • Complete Course Material will be provided including detailed information about the entire work flow of Drug Safety Associate.

  • 3 months internship available after rigorous training in Pharmacovigilance.

  • Own CRO live Projects

  • We Provide Real Time Experience on Global Drug Safety Software with PSUR & DSUR Training.

  • Highest Placement record across all training institutes

  • Industry based SOP’s training

  • Trainers with minimum of 7+ years of experience

  • Comprehensive teaching by Medical Doctors

  • Hands on experience on Global Safety Databases used in the Industry.

  • Total 150 hours of exposure to theory, case studies and practicals.

  • Practical Hands on Training will be provided on Case Processing, Narrative Writing, MedDRA 16.1 & Who DRUG Coding.

Eligibility

Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Upon Successful completion of Course our team will provide Following

  • Resume Preparation 

  • Interview Preparation and Mock Interview Session.

  • Communication skills and personality development sessions

  • Placement Assistance

Registration

The registration will be carried out by contacting on Company Connect Consultancy. How to Apply

Programme Deliverables

A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.

  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.

  • Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.

  • All the efforts are made by faculty members to make the entire programme modules easily understandable.

  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.

  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

  • All learning and training delivery initiatives shall be conducted in English.

Certification and Membership Fees

Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure 

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Company Connect.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. 

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

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