e-Learning: Common Technical Document & eCTD

Program Lidia Cánovas, Michael Schaub Module 1: CTD basic structure

EU legislation

CTD Modules 1-5

After having passed this module you understand the CTD structure and know the eCTD necessities.

Lidia Cánovas, Michael Schaub Module 2: Organisation and content of the CTD Modules

Regional and Administrative documents (EU focus)

Overviews and Summaries

Study Report

After having passed this module you know where to include which data in the CTD dossier.

Lidia Cánovas, Michael Schaub Module 3: Dossier considerations for generics and other "un-compled" application types

Data Exclusivity

Full Application

Generic, Hybrid or Similar Biological Applications

Well Established Use Applications & Fixed Dose Combinations

Traditional Use Registration for herbal medicinal product

After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.

Lidia Cánovas, Michael Schaub Module 4: Details on CTD Module 3 content

Modul 4a: IntroductionCTD Module 3 structure and guidelines

Modul 4b: Drug Substance CTD Module 3 drug substance data requirements

Modul 4c: ASMP & CEP

Modul 4d: Drug Product CTD Module 3 - drug product data requirements

After having passed this module you have a thorough understanding of the CMC part of the marketing authorisation dossier and know how to fill in module 3 of the CTD.


Program Lidia Cánovas, Michael Schaub Module 1: CTD basic structure

EU legislation

CTD Modules 1-5

After having passed this module you understand the CTD structure and know the eCTD necessities.

Lidia Cánovas, Michael Schaub Module 2: Organisation and content of the CTD Modules

Regional and Administrative documents (EU focus)

Overviews and Summaries

Study Report

After having passed this module you know where to include which data in the CTD dossier.

Lidia Cánovas, Michael Schaub Module 3: Dossier considerations for generics and other "un-compled" application types

Data Exclusivity

Full Application

Generic, Hybrid or Similar Biological Applications

Well Established Use Applications & Fixed Dose Combinations

Traditional Use Registration for herbal medicinal product

After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.

Lidia Cánovas, Michael Schaub Module 4: Details on CTD Module 3 content

Modul 4a: IntroductionCTD Module 3 structure and guidelines

Modul 4b: Drug Substance CTD Module 3 drug substance data requirements

Modul 4c: ASMP & CEP

Modul 4d: Drug Product CTD Module 3 - drug product data requirements

After having passed this module you have a thorough understanding of the CMC part of the marketing authorisation dossier and know how to fill in module 3 of the CTD.


Program
Program


Lidia Cánovas, Michael Schaub Module 1: CTD basic structure

EU legislation

CTD Modules 1-5

After having passed this module you understand the CTD structure and know the eCTD necessities.

Lidia Cánovas, Michael Schaub Module 2: Organisation and content of the CTD Modules

Regional and Administrative documents (EU focus)

Overviews and Summaries

Study Report

After having passed this module you know where to include which data in the CTD dossier.

Lidia Cánovas, Michael Schaub Module 3: Dossier considerations for generics and other "un-compled" application types

Data Exclusivity

Full Application

Generic, Hybrid or Similar Biological Applications

Well Established Use Applications & Fixed Dose Combinations

Traditional Use Registration for herbal medicinal product

After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.

Lidia Cánovas, Michael Schaub Module 4: Details on CTD Module 3 content

Modul 4a: IntroductionCTD Module 3 structure and guidelines

Modul 4b: Drug Substance CTD Module 3 drug substance data requirements

Modul 4c: ASMP & CEP

Modul 4d: Drug Product CTD Module 3 - drug product data requirements

After having passed this module you have a thorough understanding of the CMC part of the marketing authorisation dossier and know how to fill in module 3 of the CTD.


Lidia Cánovas, Michael Schaub Module 1: CTD basic structure

EU legislation

CTD Modules 1-5

After having passed this module you understand the CTD structure and know the eCTD necessities.

Lidia Cánovas, Michael Schaub Module 2: Organisation and content of the CTD Modules

Regional and Administrative documents (EU focus)

Overviews and Summaries

Study Report

After having passed this module you know where to include which data in the CTD dossier.

Lidia Cánovas, Michael Schaub Module 3: Dossier considerations for generics and other "un-compled" application types

Data Exclusivity

Full Application

Generic, Hybrid or Similar Biological Applications

Well Established Use Applications & Fixed Dose Combinations

Traditional Use Registration for herbal medicinal product

After having passed this module you have a deep understanding of the possible legal basis for marketing authorisations in Europe and know which legal basis might be applicable to your product.