TypeOnline Course
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pharmacovigilance training

Pharmacovigilance training course gives you a good understanding of the basic principles of drug safety and adverse drug reaction management. The course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings. The pharmacovigilance course also provide the detailed training on the signal detection & risk management.

Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

  • Course Code – KPE-C-044
  • Course Title: Certificate Course in Pharmacovigilance

Nature of the Course:

Distance & e-Learning

Eligibility

Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e. Doctors of all disciplines, junior professionals in Pharmaceutical and IT Industry, Clinical Research professionals. 3rd and final year graduation students can also apply for the course.

Duration:

1 Month.

Deliverable

  • Printed Book dispatched to correspondence address (For admission from India). Incasse of admission other than India e-books will be sent to registered email id.
  • Access the E-Modules online with user id and password.
  • Attend lectures online.
  • Access to case study file online
  • All e-study material contains self assessment computer based test.
  • Flexible online final examination.

 

Section 1Introduction : Drug Discovery and R&D Fundamentals
Lecture 1Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Review on Drug Discovery and Development 
Section 2Clinical Research
Lecture 7Clinical Trials Terminologies 
Lecture 8Clinical Trial Protocol Writing
Lecture 9Ethics in Clinical Research
Lecture 10Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Pharmacovigilance : ADR
Lecture 11Introduction to Pharmacovigilance
Lecture 12Introduction to Adverse Drug Reactions
Lecture 13ADR: Pharmacology
Lecture 14Controversies on ADR
Lecture 15ADR: Classification
Lecture 16PV and ADR Monitoring
Lecture 17ADR and Related Terminologies
Lecture 18ADR Reporting System 
Lecture 19DoTS
Lecture 204 Elements of AEs
Lecture 21ADR Reporting Limitations
Lecture 22ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 23The Adverse Drug Reaction (ADR) Probability Scale
Section 4Pharmacovigilance Process
Lecture 24Pharmacovigilance Process
Lecture 25PSURs
Lecture 26Risk Management
Section 5Pharmacovigilance regulatory authorities
Lecture 27Introductions
Lecture 28United States
Lecture 29COSTART
Lecture 30MedDRA
Lecture 31Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 32European Union
Lecture 33The World Health Organization (WHO)
Lecture 34WHOART
Lecture 35The International Conference on Harmonization (ICH)
Lecture 36The Council for International Organizations of Medical Sciences (CIOMS)
Lecture 37The International Society of Pharmacovigilance (ISoP)
Lecture 38Active surveillance schemes
Lecture 39EudraLex
Section 6Pharmacovigilance Framework
Lecture 40Pharmacovigilance framework
Lecture 41SmPC / SPC
Lecture 42Pharmacovigilance Software
Lecture 43Good Pharmacovigilance Process (GPVP)
Section 7Case Study
Section 8Role of Drug Safety Associates