Two Day Course: Common Technical Dossier - Regulatory and Technical Requirements for CMC Management (London, United Kingdom - December 5th-6th, 2017)

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.

Project Management/Collection of Critical Documents for Chemistry, Manufacturing and Control (CMC) for Global Registration (CTD) & Incorporate Quality by Design within the CTD.

This course will cover the following topics:

Who Should Attend:

Agenda:

Day 1 Schedule

What is the CTD? The road map to Module 3 Understanding ICH

Preparing the drug substance section of the application - US and EU

GMP for Active Substances

Case study: Essential information from API suppliers

Examining the content of the sections concerning the drug product. Composition and development of the drug product

Day 2 Schedule

(All Module Sections include Example Sections for Writing)

Writing the section on manufacture of the drug product and process validation

Writing the sections on Excipients and Packaging Components

Writing the sections on control of the finished product and Case Study

Writing the stability section

The function and content of the Quality Overall Summary

Examining Global Roll-out of CTD - Module 3

Examining Change Control - Practical tips

Practical Exercise in Generic Development

For more information about this conference visit https://www.researchandmarkets.com/research/j4t8sf/common_technical

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