DUBLIN, Sept. 9, 2015 /PRNewswire/ -- Research and Markets (http://www.researchandmarkets.com/research/qk69wn/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/qk69wn/common_technical
Laura Wood, +353-1-481-1716, email@example.com
SOURCE Research and Markets