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Pharmacovigilance – Post Graduate Diploma

pharmacovigilance

Post Graduate Diploma in Pharmacovigilance

 

Pharmacovigilance is the process of identifying and responding to drug safety issues and has grown considerably as a discipline over the past 10 to 15 years. We know that, Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. 

The pharmacovigilance industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit.

Post Graduate Diploma in Pharmacovigilance is blended (Online + Offline) program in pharmacovigilance provides you basic & advance knowledge  in pharmacovigilance principles and operations. The program also provides training on pharmacovigilance systems, global safety standards, guidelines and regulations & hands on training related to pharmacovigilance. The training curriculum is fully designed by expert faculty and is appropriate for candidates who wish to enter the pharmacovigilance sector.

 

Eligibility:  B.Pharm / M. Pharm / Life science/ Medical graduates and post graduates

Duration:  6 Months ( 4 Months Theoretical + 2 Months Practical Internship )

Placement:  100% Internship with placement assistance

 

Course Curriculum:

  1. Introduction to Clinical Research 

 

    2. ICH GCP Guidelines

 

    3. New Drug Development Process

 

    4. Project Management

 

  • General Overview of Pharmacoviglance

 

  • PV- Basic principles of PV and AE/ADR Reporting system

 

  • Global Pharmacoviglance Regulatory Requirements in Pharmacoviglance

 

  • Safety Data Management

 

  • Safety Data Reporting

 

  • General Overview of GVP

 

  • Quality in Pharmacovigilance

 

  • Safety Signal management

 

  • Drug Safety in Clinical Trials

 

  • Overview of Safety Database and forms used in the actual scenario

 

Other benefits:

      • 100% Internship with Placement assistance
      • Digital Notes
      • Industry Based Learning
      • Faculty with 20+ years of Clinical research Industry Experience
      • Live Interactive Sessions
      • Limited Seats Batch
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