e-Learning: Marketing Authorisation Outside the ICH Region

Program Module 1: Key principles

ICH

WHO

Non-ICH region

Acceptance of data

Registration planning

Registration scenarios

After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.

Module 2: The Marketing Authorisation Dossier

International Council for Harmonisation

CTD / eCTD

Acceptance of CTD / eCTD / electronic submission

Other formats

Dossier requirements inAustralia

Hong Kong

India

South Korea

Taiwan

Saudi Arabia

GCC

Jordan

Turkey

Thailand

China

South Africa

Russia

Kazakhstan

Eqypt Brazil

Mexico

Argentina

Additional requirements and summary

Q & A

After having passed this module you know the dossier requirements in the mentioned countries including the acceptance of an ICH (e)CTD.

Module 3: Countries with or without CPP requirements

What is a CPP

Overview of CPP dependent and non CPP dependent countries

Regulatory submission strategy based on CPP

After having passed this module you know which countries depend on a CPP and have hints how to develop your submission strategy.


Program Module 1: Key principles

ICH

WHO

Non-ICH region

Acceptance of data

Registration planning

Registration scenarios

After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.

Module 2: The Marketing Authorisation Dossier

International Council for Harmonisation

CTD / eCTD

Acceptance of CTD / eCTD / electronic submission

Other formats

Dossier requirements inAustralia

Hong Kong

India

South Korea

Taiwan

Saudi Arabia

GCC

Jordan

Turkey

Thailand

China

South Africa

Russia

Kazakhstan

Eqypt Brazil

Mexico

Argentina

Additional requirements and summary

Q & A

After having passed this module you know the dossier requirements in the mentioned countries including the acceptance of an ICH (e)CTD.

Module 3: Countries with or without CPP requirements

What is a CPP

Overview of CPP dependent and non CPP dependent countries

Regulatory submission strategy based on CPP

After having passed this module you know which countries depend on a CPP and have hints how to develop your submission strategy.


Program
Program


Module 1: Key principles

ICH

WHO

Non-ICH region

Acceptance of data

Registration planning

Registration scenarios

After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.

Module 2: The Marketing Authorisation Dossier

International Council for Harmonisation

CTD / eCTD

Acceptance of CTD / eCTD / electronic submission

Other formats

Dossier requirements inAustralia

Hong Kong

India

South Korea

Taiwan

Saudi Arabia

GCC

Jordan

Turkey

Thailand

China

South Africa

Russia

Kazakhstan

Eqypt Brazil

Mexico

Argentina

Additional requirements and summary

Q & A

After having passed this module you know the dossier requirements in the mentioned countries including the acceptance of an ICH (e)CTD.

Module 3: Countries with or without CPP requirements

What is a CPP

Overview of CPP dependent and non CPP dependent countries

Regulatory submission strategy based on CPP

After having passed this module you know which countries depend on a CPP and have hints how to develop your submission strategy.


Module 1: Key principles

ICH

WHO

Non-ICH region

Acceptance of data

Registration planning

Registration scenarios

After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.

Module 2: The Marketing Authorisation Dossier

International Council for Harmonisation

CTD / eCTD

Acceptance of CTD / eCTD / electronic submission

Other formats

Dossier requirements inAustralia

Hong Kong

India

South Korea

Taiwan

Saudi Arabia

GCC

Jordan

Turkey

Thailand

China

South Africa

Russia

Kazakhstan

Eqypt Brazil

Mexico

Argentina

Additional requirements and summary

Q & A

After having passed this module you know the dossier requirements in the mentioned countries including the acceptance of an ICH (e)CTD.

Module 3: Countries with or without CPP requirements

What is a CPP

Overview of CPP dependent and non CPP dependent countries

Regulatory submission strategy based on CPP

After having passed this module you know which countries depend on a CPP and have hints how to develop your submission strategy.


Module 1: Key principles

ICH

WHO

Non-ICH region

Acceptance of data

Registration planning

Registration scenarios

After having passed this module you know the working principles of ICH and WHO. You understand the differences to the Non ICH regions including national requirements for stability data and further conditions.


Module 1: Key principles

ICH

WHO