Title         Pharmacovigilance in the Pharmaceutical Industry

Online Course Modality

Date          Friday 28 and Saturday 29-August-2020

Duration          6 hours

Schedule          Friday 28 (15: 00-18: 00 hours)

                          Saturday 29 (09: 00-12: 00  hours)

Speaker          QA Dinath Emireth González Riverón

Platform          Zoom

cost

$ 1500.00 VAT Included

It includes

• Online course 6 hrs
• Online speaker
• Digital material
• Electronic diploma
• Constancy DC-3 (STyPS)

Contents

• Introduction to Pharmacovigilance: History and legal framework
• Role of the Pharmacovigilance Unit in the private and public sector
• Process of reporting suspected adverse reactions to drugs, vaccines and medical devices and their notification to the National Pharmacovigilance Center

         -Drug notifications through the VigiFlow platform

         -Notifications of vaccines through the official ESAVI format

• Security Reports

         -Analysis of the structure according to the request of the official guides of:

            * Periodic Safety Reports

            * Security Reports

            * Annual and final reports of clinical studies

            * Non-marketing formats

            * Impact of risk-benefit analysis of a drug, vaccine or medical device

• Risk Management Plans, classification and additional activities

       -Analysis of the structure according to the request of the official guides

       -Categorization according to the risks of the product

       -Additional activities

• Conclusions

GRADES

• The deadline to finalize your payment will be 5 days before the event.
• DO NOT REGISTER IF YOU ARE NOT SURE TO TAKE THE ONLINE COURSE SINCE YOU WILL BE MAKING THE OPPORTUNITY FROM ANOTHER INTERESTED PERSON.
• At the end of your registration, our REGULATE team will send you a registration confirmation email and the payment information will be sent.