dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr. Katja Aschermann
Astator Solutions
Dr. Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Kati Kebbel
Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Mag. Gabriela Schallmeiner
Inspection Ready Consulting, Austrian Qualified Person Association (aqpa)
Objectives
As part of this GMP course for ATMPs (Advanced Therapy Medicinal Products), you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity, lyophilisation according to the new Annex 1 and much more from various experts from authorities, industry and consulting. In addition to the GMP requirements, you will also learn about the impact and implementation of the new Annex 1.
Background
The new Annex 1 is in effect and must now be implemented. The correct interpretation and implementation in daily business is often difficult and raises many questions. Compliance with the GMP regulations is essential for the continuous, traceable and high-quality manufacture, testing and control of pharmaceutical products.
Advanced Therapy Medicinal Products (ATMPs) are a group of innovative and sophisticated medical treatments that use advanced technologies to modify or use living cells, tissues or genes for therapeutic purposes. These therapies focus on targeting the underlying causes of disease at the cellular and genetic level, with the aim of treating, preventing or diagnosing diseases. ATMPs include gene therapies, cell therapies and tissue engineered products and represent a significant step in medical treatments.
New ATMPs with innovative properties are constantly being developed. It does not matter whether it is a personalized product, production or even transport. The ultimate goal always remains a safe and effective product that provides the patient with healing or relief without harming them. To ensure this, employees must comply with the current regulations. This course offers deeper insights into the regulations and advice on implementing the new and existing requirements of ATMPs.
Target Group
This training is aimed at employees from quality assurance, quality control and production who have daily contact with ATMPs and have to work according to the existing GMP requirements. Experienced staff will have the opportunity to extend and deepen their existing knowledge in core aspects of GMP and Annex 1 Areas.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
EU-GMP Guideline Part IV: Overview Dr Rainer Gnibl
Positioning within EudraLex Vol. 4
Definition of ATMPs
Document structure & technical content
Key messages
Quality Risk Management for ATMPs Dr Rainer Gnibl
What does QRM mean?
ICH Q9 Quality Risk Management (Overview)
Bounderies & Limitations
Examples from Guideline
Freeze-drying of Vectors in the Light of Update Annex 1 Dr Sabine Hauck
Annex 1 requirements for lyophilization
Further regulatory requirements for (non-)viral vectors
Benefits of freeze-dried viral vector formulations
Aseptic Manufacturing of Cell-based ATMPs (HCGTP) Dr Katja Aschermann
Challenges
Impact of new Annex 1
Cross Contamination Control Strategy
Environmental Monitoring Dr Rainer Gnibl
Segregation between Classification, Qualification & Monitoring
Clean room lifecycle
Monitoring elements
Personell & clean room monitoring
Data Integrity of Automated, Decentralised Cell Therapy Production Dr Wolfgang Schumacher
DI concept in research-oriented smaller companies
Computer-assisted manufacturing of therapeutics
DI issues in testing, release and logistics
DI questions in the context of inspections
Contamination Control Strategy Dr Katja Aschermann
Definition
Creation of a CCS
Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing Kati Kebbel
Clarification of types of qualification and validation applied in ATMP manufacturing - supplier qualification - device qualification - software validation
Testimonials
Seminar Programme as PDF