Sat, Sep 11

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Mexico City

On-site 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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On-site Pharmacovigilance Course in the Pharmaceutical Industry

Horario y ubicación

Sep 11, 2021, 9:00 AM – 3:00 PM CDT

Mexico City, Viad. Río de la Piedad 260, Col. Magdalena Mixhuca, Venustiano Carranza, 15860, CDMX.

Acerca del evento

Title:           Pharmacovigilance in the Pharmaceutical Industry

Modality   Classroom course

Date           Saturday September 11, 2021

Duration      6 hours

Schedule         09: 00-15: 00 hours

Speaker        QA Dinath Emireth González Riverón

Campus               Hotel Holiday Inn Dalí Airport

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cost

$ 2,000.00 (PER PERSON) Taxes Included

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It includes

- Face-to-face course (Explanatory and applicative part)

- Printed material

- Ballpoint

- Continuous coffee service

- Light breakfast

- Diploma of participation issued by REGULATE

- Certificate DC-3 (Secretary of Labor and Social Welfare)

- Parking lot

   TEMARY 

  • 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

            - Vaccine notifications 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 the 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 24 hours before the course.
  • 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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