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 and U.S. It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for variations to EU marketing authorisation (MA) 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 variation
  • The categorization of post-approval changes, e.g. 1A, 1B, Type 2 in EU and CBE0, CBE30 or 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 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 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 also 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 an experienced regulatory affairs professional who has over 17 years of experience in regulatory affairs from both industry and consultancy. Jason has provided support across a broad range of projects covering both medicinal products (including several biologicals) and medical devices, supporting numerous clients in preparing documentation, managing projects (strategy, early phase development, INDs, MAAs), scientific advice meetings and regulatory training.

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.