Sat, Dec 05

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Holiday Inn Mexico Dalí Airport

Medicines Health Regulation Course: Initiation

At the end of the course, the assistant will be able to identify the most prominent concepts in the area of regulatory affairs, in order to develop satisfactorily in the area.

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Medicines Health Regulation Course: Initiation

Horario y ubicación

Dec 05, 2020, 9:00 AM – 3:00 PM

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

Acerca del evento

Title         Sanitary Regulation of Medicines: Initiation

On-site course modality

Date          Saturday 05-December-2020

Duration          6 hours

Schedule               09: 00-15: 00 hours

Speaker          QFB Azucena Justo Marcos

Campus                  Holiday Inn Mexico Dali Airport Hotel: Viad. Río de la Piedad 260, Magdalena Mixhuca, 15860 City                            from Mexico, CDMX

cost 

$ 2000.00 Taxes Included

It includes

  • Classroom course
  • 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

Contents

  1. Introduction
  2. CTD overview
  3. Regulatory process for marketing drugs
  4. Basic concepts in regulatory areas (Legal Accreditation, Authentication, Translations, Prevention)
  5. Allopathic Drug Dossier
  • Dossier types (New, extension, modifications, cancellation) 
  • Physical characteristics of the dossier
  • Elements that make up the dossier
  1.    Administrative - Legal Documentation

               *Format

               *Pay

               *License

               * Notice of sanitary manager

               * IPP's

               * Certificate of Good Manufacturing Practices

               *Patent

               * CMN

       2.  Technical documentation

 

  6. Other procedures

  • Free Writings
  • Prevention response

7. Conclusions

GRADES

  • The deadline to finalize your payment will be 1 week prior to the event.
  • DO NOT REGISTER IF YOU ARE NOT SURE TO ATTEND THE 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.
  • This course will take place with the recommended sanitary measures.

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