How to register APIs in Brazil - Live Online Training

How to register APIs in Brazil - Live Online Training

Seminar Nr. 19406

All times mentioned are CET.

Kosten

ECA-Member*: EUR 490,--
Regular Fee*: EUR 590,--
EU/GMP Inspectorates*: EUR 490,--
APIC Member Discount*: EUR 540,--

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Marieke van Dalen, Global Regulatory Specialist

Hintergrund

Since August 2020, the “CADIFA Manual of Administrative Procedures” of the Brazilian Health Regulatory Agency (Anvisa) is valid and needs to be followed for API dossiers. Now, the new version of the “CADIFA Manual” is published and available in Portuguese and in English language.1

According to the agency, the DIFA (Active Pharmaceutical Ingredient dossier) must be submitted to Anvisa by the DIFA holder to receive a CADIFA (letter of suitability of the active pharmaceutical ingredient). It shows the compliance of a DIFA with the regulatory requirements. A valid CADIFA and GMP certificate are necessary for the approval of an associated marketing authorization or post-approval change application.1

The understanding of Brazilian Registration Procedures for APIs is thus important to know. This Live Online Training provides an overview of the regulatory and GMP requirements for registering APIs in Brazil and obtaining the Brazilian GMP certificate.
 
1 Source: CADIFA Manual for Administrative Procedures, CADIFA Manual nº 01, 2nd Version

Zielgruppe

This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Specifics of the Brazilian Registration File
  • The CADIFA system
  • The DIFA (API dossier)
  • What is different from other regions?
Handling Changes in Brazil
  • Relevant guidelines
  • How does it work in practice
Obtaining the Brazilian GMP Certificate
  • Starting the GMP certificate procedure
  • Different sites & different classes of products

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