Sat, Jun 05

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Mexico City

Face-to-face course, Health Registration of Allopathic Medicines

At the end of the course, the assistant will know the applicable tools for the correct development of allopathic drugs in various pharmaceutical forms.

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Face-to-face course, Health Registration of Allopathic Medicines

Horario y ubicación

Jun 05, 2021, 9:00 AM – 3:00 PM CDT

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

Acerca del evento

Title               Sanitary Registry of Allopathic Medicines

Modality        Classroom course

Date               June 05, 2021

Duration          6 hours

Schedule             09: 00-15: 00 hours

Speaker           QFB Azucena Justo Marcos

Campus                Hotel Holiday Inn Dalí Airport    

cost

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$ 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

1. Introduction

2. Regulatory process for the commercialization of a drug in Mexico.

3. Legal Basis of the Sanitary Registry

4. Modalities of drug files

5. File Integration

   A. New Molecule

               I. Administrative-Legal Information

                * Format / Payment

                * Legal Accreditation  

                *License/  Health Responsible Notice  

                * Label project

                * CBPF / Patent / CLV

                *Distinctive denomination

                * CMN

              II.  Quality information

                 -Drug Information

                 * Drug Master File (Open part)

                 * Drug Control

 

                 -Aditives

                 -Finished product

                 -Container closure system

              III. Preclinical Studies / Clinical Studies

              B. Generic

6. Format

7. Homoclaves. Check list

8. Approval times and Causes for not granting the Sanitary Registry

9. 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 TAKE 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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