eCTD preparation and submission

Program

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Efficient baseline creation

• Step-by-step guide to baseline submissions
• Mandatory and optional scope of baselines
• Identifying the currently valid version of your documentation

eCTD compilation and submission

• Best practice for eCTD compilation, submission and review
• Typical validation issues and how to avoid them
• Best practice: Practical short exercises

Program

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Efficient baseline creation

• Step-by-step guide to baseline submissions
• Mandatory and optional scope of baselines
• Identifying the currently valid version of your documentation

eCTD compilation and submission

• Best practice for eCTD compilation, submission and review
• Typical validation issues and how to avoid them
• Best practice: Practical short exercises

Program

Program

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Efficient baseline creation

• Step-by-step guide to baseline submissions
• Mandatory and optional scope of baselines
• Identifying the currently valid version of your documentation

eCTD compilation and submission

• Best practice for eCTD compilation, submission and review
• Typical validation issues and how to avoid them
• Best practice: Practical short exercises

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Efficient baseline creation

• Step-by-step guide to baseline submissions
• Mandatory and optional scope of baselines
• Identifying the currently valid version of your documentation

eCTD compilation and submission

• Best practice for eCTD compilation, submission and review
• Typical validation issues and how to avoid them
• Best practice: Practical short exercises

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

Your programme Screening and editing essential marketing authorisation documents

• eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD
• Granularity, bookmarks and hyperlinks - options and requirements
• The eASMF - reduced-scope eCTDs for drug substances

eCTD document authoring and technical preparation - structures and processes to develop documents suitable for the eCTD

Granularity, bookmarks and hyperlinks - options and requirements

The eASMF - reduced-scope eCTDs for drug substances

Efficient baseline creation

• Step-by-step guide to baseline submissions
• Mandatory and optional scope of baselines
• Identifying the currently valid version of your documentation