Pharmacovigilance course (online - spanish)

Modality

Online. The course is in spanish. You can take the course from anywhere. It is only necessary that you have an Internet connection. It is a live course, where you can take the class live and you can interact with the speaker, ask questions, participate, etc.

Who is it for?

This course is aimed at health professionals, health officials, personnel in the area of quality assurance, regulatory affairs, medical management and in general to all professionals involved in Pharmacovigilance activities that require updating on the guidelines of the new NOM- 220-SSA1-2016 "Installation and operation of Pharmacovigilance".

Objectives

1. That the participant knows clearly and easily the guidelines of the new NOM-220-SSA1-2016 Installation and operation of the Pharmacovigilance.

2. That the participant knows how to comply and apply the guidelines in the matter.

3. At the end of the course, the participant will be able to identify the requirements for the implementation and preparation of:

a) Notification of cases to the authority.

b)    Reportes periódicos de seguridad (NotiReporta).

c) Safety reports of clinical studies.

d) Risk management plans.

Course Content

 

MODULE I. INTRODUCTION TO NOM-220-SSA1-20161.

1.1 Review of the most important requirements of the new NOM-220-SSA1-2016.

1.2. Pharmacovigilance system in Mexico.

MODULE II. NOTIFICATION OF CASES

2.1 Adverse Reaction, Adverse Event and safety problems related to the use of medication.

2.2 Report and notification of cases to COFEPRIS.

MODULE III. PERIODIC SAFETY REPORT

3.1 Review of the structure of the Periodic Safety Report in Mexico.

3.2 Revisión de los lineamientos para el sometimiento a COFEPRIS (NotiReporta).

MODULE IV. CLINICAL STUDY SECURITY REPORT 

4.1 Review of the structure of the Clinical Studies Safety Report.

4.2 Review of the guidelines for submitting to COFEPRIS.

MODULE V. RISK MANAGEMENT PLAN

5.1 Review of the structure of the Risk Management Plan in Mexico.

5.2 Review of the guidelines for submitting to COFEPRIS.

MODULE VI. Pharmacovigilance Unit

5.1 Implementation of a Pharmacovigilance Unit

Duration

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12 total hours.

Dates

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Por definir.

Schedule

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9 to 15 hrs.
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