Regulatory Affairs for QA: Variations Training

About This Course

Our regulatory affairs for quality assurance (QA) professionals’ training is an interactive refresher course focused on the variations in process requirements and categorizations found in the EU, UK and U.S. It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for variations to EU marketing authorisations (MAs) and post-approval changes to U.S. New Drug Application (NDA)/Abbreviated New Drug Application (ANDA)/Biologics License Application (BLA) submissions.

During our training course, we explore:

  • Regulatory agency expectations on the data that should be included in variations
  • The categorization of post-approval changes, e.g. 1A, 1B and Type 2 in the EU and CBE0, CBE30 and prior approval in the U.S.
  • The need for the QP/QA to be kept informed regarding post-approval changes via an effective change control process
  • New/emerging expectations arising from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12

Key Learning Objectives

By the end of this regulatory affairs training, QA professionals will improve and expand their:

  • Awareness and knowledge of the latest regulatory procedures for post-approval changes
  • Knowledge on how EU, UK and U.S. regulatory procedures work
  • Ability to communicate with their regulatory support functions

Course Tutors

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 regularly presents at The Organisation for Professionals in Regulatory Affairs (TOPRA) meetings and provides training within the industry on regulatory affairs.

Jason Collins – Jason is a seasoned regulatory professional who has been working in pharmaceutical regulatory affairs for more than 20 years. He has broad experience in medicines and medical device regulations, including advanced therapies, pediatric investigation plans, immunological products and radiopharmaceuticals, and site licensing support. Jason is also a keen supporter of TOPRA and is a module leader on their MSc Medical Device programme.