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Quality Aspects of the CTD


How to assure Flexibility, Practicality and Compliance

Dates: Monday 11 to Thursday 14 November 2013
Hilton York Hotel, York, UK

£2400.00 excl. VAT – £2880.00 incl. VAT

Type: Pharmaceutical

About this course

The ever-increasing complexity of obtaining approval for drug products requires that companies provide high quality registration applications. To achieve this objective, it is essential that personnel in Regulatory Affairs, Research & Development, Manufacturing and Quality Assurance understand regulatory requirements and work together as an effective team.

The ICH Common Technical Document (CTD) has brought the possibility of a global dossier many steps closer. This emphasises the importance of getting it right first time.

NSF-DBA and Regulatory Resources Group have once again combined their complementary skills to present this well proven and successful pharmaceutical training course which is designed to provide attendees with a clear understanding of the regulatory process and technical data requirements for registration and subsequent manufacture of medicinal products.

Although this pharmaceutical training course will primarily focus on EU aspects, consideration will be given to corresponding aspects in US submissions.

What You Will Learn

  • Current regulatory requirements and their impact on Chemistry and Pharmacy registration requirements:
    • Legal framework
    • CTD submission structure and content
    • Data requirements for new and established products
      • How much data is enough?
    • CTD summary documents
    • Role of the EU expert
    • EU marketing authorisation procedures
    • EU clinical trial applications
    • Post approval changes (variations)
    • GMP inspections
    • Role of the EU Qualified Person

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Washington and Ann Arbor, USA

A word from NSF Health Sciences

If you do not find the course you are looking for please contact me at the NSF Health Sciences Kirkbymooorside Office

Bev Willett, Course Administrator, NSF Heath Sciences

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