Fri, Aug 28

|

Zoom

Pharmacovigilance Course in the Pharmaceutical Industry

The assistant will be able to understand the current regulatory framework of Pharmacovigilance in Mexico. Exemplify with practical cases, the notification of suspected adverse drug reactions; as well as broadening the panorama of topics such as: security reports and Risk Management Plan.

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Pharmacovigilance Course in the Pharmaceutical Industry

Horario y ubicación

Aug 28, 2020, 3:00 PM – Aug 29, 2020, 12:00 PM

Zoom

Acerca del evento

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.

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