Marieke van Dalen
MARA Consultancy
Referent:innen
Dr. Susan Swiggers
Aspen Oss
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 Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
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
Recording from 27 February 2024
Duration of Recording: 2h 30min
| 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.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Sonderkonditionen DB BahnTeilnehmerstimmen - das sagen andere über unsere Seminare:
