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Program 14: PG Diploma in Pharmacovigilance

Sale Sale
Original price Rs. 50,000.00
Original price Rs. 50,000.00 - Original price Rs. 50,000.00
Original price Rs. 50,000.00
Current price Rs. 49,000.00
Rs. 49,000.00 - Rs. 49,000.00
Current price Rs. 49,000.00

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

This module helps the students to find the scope in

    • Drug monitoring
    • Pharmaceutical preparations - adverse effects
    • Adverse drug reaction reporting
    • Product surveillance, Postmarketing
    • Legislation

 Course Content:

Section – 1 Introduction of Pharmacovigilance

  • Overview of Pharmacovigilance
  • Standard Terms and Terminology in Pharmacovigilance
  • Introduction to Databases
  • Importance of Safety monitoring

Section -2 Introduction to adverse drug reactions

  • Definitions and classification of ADRs
  • Detection and reporting
  • Causality assessment
  • Severity and seriousness assessment
  • Predictability and preventability assessment
  • Management of adverse drug reactions

Section – 3 Case Processing

  • Global Perspective of Pharmacovigilance
  • Single Case Processing
  • Case Narrative Writing

Section – 4 Coding in Pharmacovigilance

  • WHO adverse reaction terminologies
  • MedDRA and Standardised MedDRA queries
  • Eudravigilance medicinal product dictionary

Section 5- Tools used in Pharmacovigilance

  • Introduction to Argus
  • Introduction to Aris G Pharmacovigilance and safety

Section – 6 PV laws and Guideline

  • Regulatory Guideline & Laws in PV
  • SOPS in PV
  • PV Auditing and Inspection
  • Regulatory Aspects in PV

Section - 7 Pharmacogenomics of adverse drug reactions

Who should join?

Minimum eligibility criteria for application to the course would be either of the following:

  • A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate.
  • A postgraduate or graduate with Chemistry as a subject with at least 50% marks in aggregate.
  • A postgraduate or graduate in Pharmacy or Pharmaceutical Science
  • A postgraduate or graduate in Medicine
  • A graduate or equivalent degree/diploma in Nursing

Course Duration: 4 Month

The classes will be held in Biotecnika Bangalore branch/ Online. 

NB : The course duration mentioned above is not applicable if it is taken under any offer or Scheme. or in any combination thereof. The duration of course can increase or decrease based on the teachers speed.

Lab Partner: Azyme labs

Customer Reviews

Based on 4 reviews
Durgesh.C Chandra
The best faulty members, very useful and well managed course

The whole course is worth money and is nicely covered by the faculty members explaining each and every module, these kinds of course will help a lot in future as there are companies who need diploma candidates as well.

Deepak Sharma
Much needed Course, Worth money

I am very impressed with the faculty members, didn't expected this at the start, such a great platform Biotecnika has provided for students like us launching this course. It will help a lot for a good job in these kinds of field.

Mayank Srivastav
well managed course launched by Biotecnika

Its a very rare course and most of the institute does not provide it, Thanks to Biotecnika for helping those students who are looking forward to pursue a diploma in Pharmacovigilance.

Rohit Sharma
Very helpful course launched by Biotecnika

Very helpful course launched by Biotecnika, The Teaching staff have a great depth of knowledge regarding the course.