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Regulatory Requirements for a New Active Substance: Quality




Chesham, United Kingdom


04 Dec 2019 - 06 Dec 2019

Reference No: T1907367-TOP

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Key points about this Training Event

  • Display a systematic understanding of, knowledge of, and a critical awareness of the Chemistry and Pharmacy data requirements and interpretation during development of a new chemical active substance
  • Gain a comprehensive understanding of good manufacturing processes in formulation and the validation requirements in the context of drug development
  • Demonstrate conceptual understanding of the legal and regulatory requirements for the development of a new active substance including EU clinical directives, global legislation and guidelines to evaluate current research critically
Event Description

Course Outline:

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of chemistry and pharmacy data. It will cover the regulatory requirements imposed on preparing chemistry and pharmacy data, as well as the processes of preparing chemistry and pharmacy documentation such as the Common Technical Document, IMPDs and INDs.

Lectures and workshops will cover the following:

  • Understanding the application of modern approaches for preparing the chemistry and pharmacy development programme
  • The latest requirements for the role of chemistry and pharmacy in the overall drug development programme
  • The chemistry and pharmacy dossier format and structure in the EU and US
  • Drug master files and certificates of suitability
  • Analytical methods and validation
  • Manufacture of the drug products
  • Quality control of specifications for the drug substance and drug product

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge 

When & Where?

4th - 6th December 2019

De Vere Latimer Estate 


Course fee for Delegates £1,700 plus 20% VAT
Course fee for Students £1,500 plus 20% VAT

Applicant Requirements
  • Regulatory affairs professionals
Reference No: T1907367-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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