The word Pharmacovigilance came from: pharmakon (Greek), “drug;” and vigilare (Latin),“ to keep awake or alert, to keep watch.”

 

Pharmacovigilance is concerned with adverse drug reactions, or ADRs, which are officially described as “A response to a drug which is noxious and unintended including lack of efficacy of drug and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. It also includes overdose, misuse and abuse of drug”.

 

Pharmacovigilance is the science of that deals in collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological, herbalist and traditional with a view to:

  • Identifying new information about hazards associated with medicines.

  • Preventing harm to the patients.

 

The major pharmaceutical Organizations have started Pharmacovigilance Units in India and abroad for the betterment of Human Life through which will be helpful in providing good quality of life. In November 2004, the ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Program under the guidance of Directorate General of Health Services, Union Ministry of Health and Family Welfare. The CDSCO is having 60 ADR Monitoring Centre all across India reporting to 4 sub-zonal offices.

 

In addition, pharmaceutical and biotech companies are increasing their R&D efforts both for novel molecules as well as the standard market. As the stats say the market worldwide in 2008 was worth $1859.9 million and is estimated to reach $2252.2 million in 2015. This market report also stresses upon the growing trend of major drug manufacturing companies to contract out/offshore their pharmacovigilance operations to many CROs, SMOs, KPOs and BPOs in their domain of Healthcare.

 

IMPERIAL Institute of Clinical Research is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.

 

The APGD CR & PV course in IMPERIAL Institute of Clinical Research to provides a systematic understanding of the core areas of the clinical research process and pharmacovigilance methodologies which will improve skills and knowledge to the level accepted for Clinical Research and Pharmacovigilance Professionals. Apart from clinical research management, it trains students to assemble, analyze and document adverse drug reaction data in order to make regulatory decisions regarding marketed drugs.

 

The APGDCR-PV course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia which enables professionals working in the clinical research industry with the skills and knowledge required being the part of team as there are ample numbers of the professionals required in this arena.

 

Eligibility :

MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.

Mode :

Distance learning / online

Academic Assistance:  

5 hours E-learning with in-house faculty.

Exam Pattern:

E- VIVA and project submission within course validity period.

Placement Assistance:

2 hours E-session with Placement Department + 3 chances to appear for an interview with in course validity period.

Study Material:

Study Material will be provided at correspondence address.

Program Details :

Clinical Research

  • Introduction to Clinical Research, Principles of Pharmacology, Drug Discovery & Development,
  • Clinical Trail Documents. Regulatory Submissions, Roles & Responsibilities of Key Stakeholders
  • Project Life cycle Planning, Study Feasibility, Start-up, Initiation, Trial Monitoring & Closeout essentials, Clinical Trials Design & Budgeting.

  • Auditing & Quality Control & Quality Assurance in Clinical Research
  • Biostatistics & Overview of Clinical Data Management

Pharmacovigilance

  • General Overview of Pharmacovigilance, Key Terms & Terminologies, Application of Medical Dictionary for Drug Regulatory Activities MedDRA

  • Case Processing: AE/ADR Reporting Systems & Forms, Narrative Writing, Diagnosis And Management of Adverse Drug Reactions, Medical Evaluation (Causality Assessment methods) of Adverse Events

  • Quality Management System in Pharmacovigilance, Role of SOPs in Pharmacovigilance, Regulatory Guidelines & Laws in Pharmacovigilance

  • Individual Case Safety Reports
  • Periodic Safety Update Reports (PSURs) & DSUR
  • Expedited Reporting Requirements
  • Signal Detection Tools (CIOMS, EU-Vol 9A, ICH E2)
  • Introduction to ADR Database (WHO), An Overview of Pharmacovigilance Softwares – Argus, Arisglobal

 

 (* The Date of Joining is the date on which 1st study material will be dispatched to you from institute)

 

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(For more details please contact on Mob : 08511188845 or write on ahmedabad@iicrindia.com)

 

* “Fees (Registration & program fees)  once paid will not be refundable”

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