e-Learning: CTD Module 3

Program

Module 1: Introduction

• CTD Module 3 structure
• Applicable guidelines

After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.

Module 2: Drug substance part

• CTD Module 3 drug substance data requirements

After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.

Module 3: ASMF and CEP

• Application and use
• Structure
• Procedure

After having passed this module you know the roles of the ASMF and CEP and when they are used.

Module 4: Drug product part

• CTD Module 3 drug product data requirements
• Appendices and regional information

After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements, the information that should be included in the appendices and the regional information.

Program

Module 1: Introduction

• CTD Module 3 structure
• Applicable guidelines

After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.

Module 2: Drug substance part

• CTD Module 3 drug substance data requirements

After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.

Module 3: ASMF and CEP

• Application and use
• Structure
• Procedure

After having passed this module you know the roles of the ASMF and CEP and when they are used.

Module 4: Drug product part

• CTD Module 3 drug product data requirements
• Appendices and regional information

After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements, the information that should be included in the appendices and the regional information.

Program

Program

Module 1: Introduction

• CTD Module 3 structure
• Applicable guidelines

After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.

Module 2: Drug substance part

• CTD Module 3 drug substance data requirements

After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.

Module 3: ASMF and CEP

• Application and use
• Structure
• Procedure

After having passed this module you know the roles of the ASMF and CEP and when they are used.

Module 4: Drug product part

• CTD Module 3 drug product data requirements
• Appendices and regional information

After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements, the information that should be included in the appendices and the regional information.

Module 1: Introduction

• CTD Module 3 structure
• Applicable guidelines

After having passed this section you know the structure of CTD Module 3 as well as essential quality guidelines.

Module 2: Drug substance part

• CTD Module 3 drug substance data requirements

After having passed this module you are familiar with the subchapters of the drug substance part 3.2.S and the detailed data requirements.

Module 3: ASMF and CEP

• Application and use
• Structure
• Procedure

After having passed this module you know the roles of the ASMF and CEP and when they are used.

Module 4: Drug product part

• CTD Module 3 drug product data requirements
• Appendices and regional information

After having passed this module you are familiar with the chapters and subchapters of the drug substance part 3.2.P and the data requirements, the information that should be included in the appendices and the regional information.

Module 1: Introduction

• CTD Module 3 structure