About This Workshop

This interactive workshop is a pharmaceutical regulatory affairs training refresher course focused on the structure and content of a common technical document (CTD) and application routes specifically designed for QPs and other quality assurance (QA) professionals.

It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for marketing authorisation application (MAA)/New Drug Application (NDA) submissions in the EU/U.S. and other world markets. Our workshop is also relevant to medicinal products containing small molecule drug substances, biologics, generics and biosimilars, drug device combinations and borderline products.

During the workshop, we explore:

  • Regulatory agency expectations on the data that should be included in an e-CTD
  • What can (and often) goes wrong when too much/the wrong information is registered
  • The role of the QP/QA in managing what is registered
  • New/emerging chemistry, manufacturing and controls (CMC) requirements

Key Learning Objectives

By the end of your pharmaceutical regulatory affairs training you will improve and expand:

  • Your awareness and knowledge of the latest regulatory procedures and CMC requirements for major market submissions
  • Your knowledge on how different regulatory procedures work
  • Your understanding of some of the differences between EU and U.S. CMC requirements
  • Your ability to communicate with your regulatory support functions

Course Tutors

Course tutors will be selected from the following:

Helen Erwood - Helen has been working in pharmaceutical regulatory affairs/regulatory compliance for many years; she has wide experience in the regulation of medicines, medical devices and borderline/OTC/ nanotechnology products and enjoys the challenge of dealing with something that doesn’t quite fit the current regulations. Helen is also eligible to act as a nonclinical expert for EU submissions. She also regularly presents at The Organisation for Professionals in Regulatory Affairs (TOPRA) meetings and provides training within the industry on regulatory affairs.