Research and Markets: Common Technical Dossier Course – London, UK – December 14-15, 2015

DUBLIN–(BUSINESS WIRE)–Research and Markets (http://www.researchandmarkets.com/research/qjp8p8/common_technical)
has announced the addition of the “Common
Technical Dossier (London, UK – December 14-15, 2015)”

conference to their offering.

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:

– Development, analytical, formulation and quality experts to contribute
to the effective compilation of CTD and allow effective review of
documentation requiring agreement by regulators

– Drive full understanding of Quality by Design, Critical Attributes and
developing new product using the CQA Pyramid model

– Compile and submit Module 3 (CTD) of your registration dossier

– Identify development needs for applications taking a Right First Time
development approach and utilizing QBD

– Identify extent of content expected by EU and US regulators

– Provide practical experience and examples

– Achieve the quickest turnaround of your submission

– Deal effectively with your internal and external clients

– Manage the Pharmaceutical Development and Quality aspects of your
developments and registration dossier in Europe and US

– Ensure all data needed has been collected in efficient manner

– Ensure Right First Time development

– Meet the legal framework and guidelines for the CMC/ Quality part of
the dossier, and links to GMP

– Incorporate Quality By Design into your developments

Trainer: Andrew Willis BSc. (Hons), MTOPRA – Independent Consultant in
Advanced Regulatory Affairs and Pharmaceutical Development

Benefits of Attending:

This 2-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.

For more information visit http://www.researchandmarkets.com/research/qjp8p8/common_technical

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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