About This Course

Advanced therapy medicinal products (ATMPs) are an emerging class of innovative medicines, whose properties make them very different from traditional pharmaceutical medicines. They bring new, complex challenges in terms of storage, handling and maintaining a chain of custody from raw material to patient.

With the publishing of the stand-alone guidelines on Good Manufacturing Practice specific to ATMPs in November 2017, there are defined standards that provide special challenges for compliance, which we will help you to navigate during the course.

This course provides an overview of ATMPs, covering the different types and their manufacture, QC testing and logistical requirements of these products. We also provide an overview of the governing legislation and GMP requirements in force. The course includes topics such as batch record review and the QP certification and release process. Throughout the course, the typical challenges involved with the manufacturing, testing, QP certification and transportation of ATMPs is covered, including the challenges involved in certifying and releasing ATMPs with short shelf lives. Delegates also have the chance to interact with individuals who have worked with these products in both commercial and clinical settings. The day ends with key areas of focus when auditing ATMP manufacturing and testing sites.

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • Legislation and GMP requirements for ATMPs
  • Different types of ATMPs
  • Manufacture and testing of ATMPs
  • ATMP BMR review
  • ATMP logistics
  • QP certification and release, including typical issues faced by a QP
  • Auditing ATMP manufacturing and testing sites

Who Should Attend

  • Those who are responsible for quality aspects of ATMP
  • Those who implement GMP in ATMP manufacturing
  • Those involved in regulatory inspections of ATMP

Course Tutors

Robert Smith - Robert has extensive experience in ATMP manufacturing and one of his current roles is at the Cell and Gene Therapy Manufacturing Centre, Catapult. One of Robert’s key achievements was bringing the first ATMP drug/device combination to the global marketplace, by working on both the clinical trials as well as the marketed product.

Pauline Johnstone - Pauline is a Qualified Person with over 25 years of experience in various quality roles. She has worked with a number of ATMPs in early-phase clinical trials for the last 10 years. Pauline is a trained auditor specializing in sterile products, blood products and the global supply chain.