e-Learning: EU Variation System & Procedures

Program Module 1: Overview of the EU law and Guidelines Content:

European Union law covering marketing authorisation procedures

Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents

Learning objectives: After having passed this module you can

understand the principles of the European law covering Marketing Authorisation procedures including variations

you know which guidance documents are applicable for variations and where you can find

Module 2: Classification of Variations Content:

Category of variations and decision tree

Recommendation on unforeseen variations (Article 5)

Types of variations: Type IA / IAIN; Type IB; Type II

Extensions of marketing authorisations

Pre-submission query service

Learning objectives: After having passed this module

you will be able to differentiate between the types of variations

understand what recommendations according to Article 5 are

gain insight into the documentation requirements of the applications

you know what an extension application entails

Module 3: Procedural Aspects of Variations Conten:

Centralised and mutual recognition variation procedure: Type IA / IAIN; Type IB; Type II

Variation milestone dates

Urgent safety restrictions

Learning objectives: After having passed this module

you understand the procedural aspects of the variation and with regards to timelines

you know when to implement the change

gain insight into the milestone dates for the variations

understand what an Urgent Safety Restriction is

Module 4: Grouping and Worksharing

Legal context and definitions

Grouping

Worksharing

Module 5: Application form et cetera

Electronic application form; data on medicines - SPOR

Cover letter

eCTD requirements

Editorial changes

Module 6: Other Post-Authorisation Procedures

Article 61(3) notifications

Marketing authorisation validity

Marketing status report and marketing cessation

Renewal; Post-Authorisation Measures (PAMs)

Repeat-Use procedure; marketing authorisation transfer; change of RMS

Referral procedures

Program Module 1: Overview of the EU law and Guidelines Content:

European Union law covering marketing authorisation procedures

Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents

Learning objectives: After having passed this module you can

understand the principles of the European law covering Marketing Authorisation procedures including variations

you know which guidance documents are applicable for variations and where you can find

Module 2: Classification of Variations Content:

Category of variations and decision tree

Recommendation on unforeseen variations (Article 5)

Types of variations: Type IA / IAIN; Type IB; Type II

Extensions of marketing authorisations

Pre-submission query service

Learning objectives: After having passed this module

you will be able to differentiate between the types of variations

understand what recommendations according to Article 5 are

gain insight into the documentation requirements of the applications

you know what an extension application entails

Module 3: Procedural Aspects of Variations Conten:

Centralised and mutual recognition variation procedure: Type IA / IAIN; Type IB; Type II

Variation milestone dates

Urgent safety restrictions

Learning objectives: After having passed this module

you understand the procedural aspects of the variation and with regards to timelines

you know when to implement the change

gain insight into the milestone dates for the variations

understand what an Urgent Safety Restriction is

Module 4: Grouping and Worksharing

Legal context and definitions

Grouping

Worksharing

Module 5: Application form et cetera

Electronic application form; data on medicines - SPOR

Cover letter

eCTD requirements

Editorial changes

Module 6: Other Post-Authorisation Procedures

Article 61(3) notifications

Marketing authorisation validity

Marketing status report and marketing cessation

Renewal; Post-Authorisation Measures (PAMs)

Repeat-Use procedure; marketing authorisation transfer; change of RMS

Referral procedures

Program
Program


Module 1: Overview of the EU law and Guidelines Content:

European Union law covering marketing authorisation procedures

Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents

Learning objectives: After having passed this module you can

understand the principles of the European law covering Marketing Authorisation procedures including variations

you know which guidance documents are applicable for variations and where you can find

Module 2: Classification of Variations Content:

Category of variations and decision tree

Recommendation on unforeseen variations (Article 5)

Types of variations: Type IA / IAIN; Type IB; Type II

Extensions of marketing authorisations

Pre-submission query service

Learning objectives: After having passed this module

you will be able to differentiate between the types of variations

understand what recommendations according to Article 5 are

gain insight into the documentation requirements of the applications

you know what an extension application entails

this module

you will be able to differentiate between the types of...