Invitation Registration Form Brochure
Schedule
Facilitator of Workshop

Index Medical College & HRC Index Institute of Dental Sciences Index Nursing College Index Institute of Health Sciences Index Paramedical College Amaltas College of Pharmacy Amaltas College of Management
 
Workshop Schedule
 
WORKSHOP ON PHARMACOVIGILANCE - PRACTICE AND PROSPECT
 
Venue: Index Medical College, Hospital & Research Centre, Indore
 
1st to 3rd July 2013
Monday, 1st July 2013
Time Topic Facilitator
 08:30-09:30  Registration /Breakfast/Pharmacovigilance Awareness Questionnaire  
 09:30-09:45  Welcome and Introduction to the  workshop  Dr. Sudhir Bansod
 09:45-10:15   Pre Test  Dr. Sukanta Sen / Dr. Sachin Kuchya
 10:15-11:00  Adverse drug reactions (ADRs) –  Mechanisms and risk factors  Dr. S.P.Dhaneria
 11.00-11.50  Toxicology and early detection of ADRs  Dr. Prem Nyati
 11:50-12.00  Tea break
 12:00 – 13.15  Basics concepts in Pharmacovigilance -  Part 1
 Data collection, Data processing, Data  evaluation, Labeling, Risk Management 		 Dr. Sudhir Bansod
 13:15-13:45  Lunch
 13.45-15:00  Basics concepts in Pharmacovigilance
 - Part 2
 Seriousness, Severity, Causality,  Expectedness 		 Dr. Sudhir Bansod
 15:00-15:15  Tea break
 15:15-16:30  Drug-Drug interactions (DDIs)  Dr.Sachin Kuchya
     
 Tuesday, 2nd July 2013
 8.45- 9.30  Breakfast
 9:30-10:00  First day review  Dr. Sudhir Bansod
 10:00-11:00  Regulatory affairs relating to  pharmacovigilance in India   Dr Shantanu Tripathi
 11:00-11:15  Tea break
 11:15-12:45
  • Collection of safety data - clinical trials and post-marketing setting
  • Safety databases – data entry and retrieval
  • MedDRA and other standard coding dictionaries
  • Issues with coding of adverse events
  Dr. Sudhir Bansod
 12:45-13:15  Lunch
 13:15-15:00
  • Single case evaluation for causality – temporality, latency, dechallenge, rechallenge, alternative etiologies
  • Bradford-Hill criteria - Causality and correlation in drug safety data
  Dr. Sudhir Bansod
 15:00-15:15  Tea break
 15:15-16:45
  • Concepts in epidemiology relating to drug safety
  • Epidemiological study types – case series, cohort studies, case-control studies, randomised clinical trials
  • Practical uses of epidemiology databases in pharmacovigilance
  • Dr. Sudhir Bansod


  • Dr.Sukanto Sen



  • Dr. Sudhir Bansod
     
 Wednesday, 3rd July 2013
 8.45-9.30  Breakfast
 9:30-09:45  Second day review  Dr. Sudhir Bansod
 09:45-11:00
  • Signal detection, Issue analysis reports
  • Regulatory safety reports (PSUR, PBRER)
  • Risk management plans
  Dr. Sudhir Bansod
 11:00-11:15  Tea break
 11:15-13:00  Group Work (SAE form filling, MedDRA  coding, case evaluation)  Dr. Sudhir Bansod/ Dr.Sachin  Kuchya
 13:00-13:30  Lunch
 13:30-15:00
  • Product labels - CCSI, USPI, EU SPC, India PI
  • Regulatory, legal, ethical aspects of pharmacovigilance
  • Drug safety scenario in India - offshoring, future prospects
  • Scenario of drug safety in standard global pharmaceutical companies
  • Career prospects for students
  Dr. Sudhir Bansod
 15:00-15:15  Tea Break
 15:15-15:45  Post Test  Dr. Sachin Kuchya / Dr. Sukanta Sen
 15:45-16:30  Feedback  Dr. P. Nyati / Dr. Sukanta Sen
 16:30-17:00  Valedictory Function