Event price: $ 770,000 COP

Online payment: At the time of your registration you will be able to pay online with credit card and PSE.

Payment in banks:
Present the invoice printed in laser, and approach the following banking entities:

  • Bancolombia
  • Itaú
  • Banco de Bogotá and its banking correspondents: Almacenes Éxito, Carulla, Surtimax, Súper inter.

Face-to-face payment:
Go to the University Cashier and pay with a debit or credit card.

Start date: 03-07-2019

End date: 04-07-2019

Duration: 2.00 hours.

Event city: Medellin

Hours: starts Wednesday, July 3 and ends on Friday, September 6, hours Wednesday and Friday from 5:00 pm to 7:00 pm Place: Calle 10 A # 22- 04 CES University, town hall, classroom to be confirmed.

Learn about our discounts for our university community, or if you are an employee or associate of institutions with current agreements with the CES University Learn more

Event Code: 70061913

To register, you must fill out the form to generate the invoice and make the payment online, banks or in person at the University.

Faculty: Pharmaceutical Chemistry

Carolina Valencia Medina
Assistant Faculty of Sciences and Biotechnology
svalenciam@ces.edu.co
(57) (4) 444 05 55 ext 1240

Julie Benavides
Extension Coordinator
jbenavides@ces.edu.co
(57) (4) 444 05 55 Ext. 1587

you have doubts? Write to us

Description

Know the importance of the topics to be addressed during the development of the Course

Addressed to

We share the characteristics or requirements that you must meet to be part of this Course

Modality

The modality of the event is Face-to-face

A generic medicine is a medicine that contains an active ingredient already known and previously developed and invented by others. After the expiration of the Patent that protects it, it can be manufactured by any pharmaceutical company in the world. The cost of these generic or multi-source products must be less than their original counterparts. But as the clinical effects and the risk-benefit balance of a drug do not depend exclusively on the pharmacological activity of the active substance, the world Regulatory Agencies require as a pre-requisite for their commercialization the demonstration of bioequivalence of generic drugs.
The concept of bioequivalence between two products is fulfilled when these two products have comparable bioavailability under appropriate experimental conditions.

This course is especially recommended for professionals in the area of health and pharmaceutical sciences. Aimed especially at pharmaceutical and medical chemists. The application requirements are to be in possession of a university professional degree or an equivalent bachelor's degree.

The work methodology will be face-to-face: workshops, master classes and weekly meetings.

Financing

Find out how you can finance your registration in this event.

Study plan

Find the contents to be dealt with in the Continuing Education Course

Objective

Know the skills that you will acquire when taking the Course at our University.

Finance the payment of your registration with SUFI, contact the advisor:

Anderson Acevedo Benitez
Telephone: (57) (4) 604 91 25
Mobile: 301 254 98 44
Email: anaceved@bancolombia.com

Payment with Severance:
Check with your fund and severance management company about the requirements to make the payment *.
* Applies for diplomas and certifications.

  • Stages of the bio-exemption study. Demonstration of API solubility. Demonstration of API permeability. Characterization of the dissolution of the pharmaceutical product
  • Know basic concepts of Biopharmacy and Pharmacokinetics that allow understanding the aspects of pharmaceutical equivalence, bioavailability, bioequivalence, therapeutic equivalence, etc.
  • Medicines that do not have to be shown bioequivalence
  • Medications that require demonstration of bioequivalence
  • Characteristics that the pharmaceutical product must demonstrate to be a candidate for a bioequivalence study.
  • Related Colombian and International Regulations. Challenges to implement a bioequivalence center
  • GLP and analytical methodology
  • Good Clinical Practices
  • Experimental designs of a Clinical Bioequivalence study
  • Fundamental pharmacokinetic parameters for a BE study. Concepts and their calculation
  • Special situations in BE studies. The case of enantiomers, metabolites, etc.
  • Bio-exemption studies. Characteristics that the active principle (API) and the pharmaceutical product must demonstrate to be a candidate for a bio-exemption study
  • Stages of the bio-exemption study. Demonstration of API solubility. Demonstration of API permeability. Characterization of the dissolution of the pharmaceutical product
  • Interchangeability concept

The ultimate objective of this entire process is to make quality drugs available to society, which can also contribute to a more rational use of economic resources in the health system

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