Marieke van Dalen
Aspen Oss
Referent:innen
Dr. Susan Swiggers
Aspen Oss
All times mentioned are CET.
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.
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
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
How to Handle Brazilian Registrations
- Different ways of submitting API information
- Procedural aspects
- Guidelines
Content of the 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
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 690,- |
| APIC Member Discount*: | € 740,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen - das sagen andere über unsere Seminare:
