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Pharmacovigilance

Pharmacovigilance

Overview
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. This course provides an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies and medical devices), with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem.
Curriculum

Why to take this course:

  • Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary
  • Outline how drug safety / pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies. 
  • Sketch how a product safety database is compiled, how a product’s safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers.
  • Apply appropriate terms to describe different types of adverse effect.
  • Specify requirements to report adverse reactions to regulators. 

Course curriculum:

  • Drug discovery process 
  • Phases of clinical trials
  • Good clinical practice  
  • Scope and process flow of Pharmacovigilance  
  • Pharmacovigilance glossary  
  • Safety databases  
  • Types of cases  
  • Case Assessment which includes
  • Duplicate check  
  • Check the validity of case 
  • Seriousness  
  • Medical coding using MedDRA, CDD and WHODD
  • Causality and Listedness assessment  
  • Narrative writing  
  • Regulations and timelines Introduction to Medical Writing  
  • Introduction to Data Management
  • Preparation of CV  
  • Mock interview  

Required Educational Qualifications in under graduation:

B.Pharmacy, Nursing, MBBS, Physiotherapy, BDS (dentist), Homeopathy/Ayurvedic, Biochemistry, Biotechnology, Microbiology, B.Sc biology/Zoology and any Para-medical and life sciences background. 

Educational qualification in USA (M.S):

All healthcare related fields (Parma, nursing, healthcare management, public health etc), Chemistry, Regulatory Affairs, All Management fields and Information systems/Information Technology (I.T) with any of the above under graduation can apply for this position. 

Target industries:

All the pharmaceutical companies, CROs (clinical research organizations), BPO/KPO (like Accenture, Cognizant, TCS etc). 

Target Positions:

Drug Safety Associate, Pharmacovizilance Associate, Drug Safety Co-coordinator, Sr. Drug Safety associate, Pharmacovigilance specialist, Pharmacovizilance Scientist, Case processing associate/specialist etc. 

Course structure:

Total hours of training: 20-25 hours 

Duration of training: less than 2 weeks 

Material: Well prepared material which includes PPTs and PDFs and Database documents will be provided. 

Resume Preparation: Resume preparation will be done once the candidate completes the training 

Key concepts of the Course: Adverse events, Medical coding, Product coding, MedDRA, WHO-DD, CDD, Narrative writing, Argus database, ARISg database, ICSRs (individual case safety report), Aggregate reporting, PSURs/DSURs, Suspect drugs, concomitant medications, De-challenge, Re-challenge, Investigations, SAE reconciliation etc. 

Features
Real Life Case Studies

Real Life Case Studies

Projects modeled on select use cases with implementation of diverse technology concepts

Assignments

Assignments

All guided classes and courses are mandatorily followed by useful practical assignments

24x7 Expert Support

24x7 Expert Support

Every technical query is resolved on demand with readily available expert assistance

Instructor-led Sessions

Instructor-led Sessions

Technical session conducted under the guidance of qualified and certified educationists

Course Info

Course Start Date 05/20/2024
Estimated Duration 3/4 Weeks
Maximum Students 10
Levels Advanced

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