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Focus on Tissue: A Multidisciplinary Approach - Live Online Training

Thursday, 19 September 2024 9 .30 - 15.30 h

Seminar-Nr. 21300

Referent:innen

Dr. Verena Plattner

Dr. Verena Plattner

AGES

Dr. Katja Aschermann

Dr. Katja Aschermann

TETEC

Dr. Pia Strasser

Dr. Pia Strasser

AGES

All times mentioned are CEST.

Zielsetzung

In this live online training you will be familiarized with the current regulatory requirements for Tissue Engineered Medical Products (TEMPs) and experts from authorities and industry will give you an insight into important topics related to TEMPs such as the management of process changes, donor eligibility, transport and storage as well as biovigilance.

Hintergrund

Tissue engineering and the development of Tissue Engineered Medical Products (TEMPs) represent an innovative and rapidly evolving field that merges the principles of engineering and biological sciences. The primary aim is to develop biological substitutes that can repair, replace, maintain or enhance tissue function. These innovative therapy methods open up new possibilities in biological reconstruction. Cartilage, bone and skin defects can be treated with autologous tissue replacement. However, the path from conceptualization to clinical application of TEMPs is fraught with unique challenges and stringent regulatory requirements.

One of the most significant challenges in the field of tissue engineering is related to the use of allogeneic donors - donations from individuals genetically different within the same species - for the creation of TEMPs. The field must navigate the complexities of process changes in the manufacturing of TEMPs, which can significantly impact the product's characteristics. Such changes require rigorous validation to ensure they meet the stringent standards set by regulatory bodies and are safe for patient use.

The transportation and storage of cells and tissues for medical applications are governed by comprehensive regulatory requirements designed to preserve their viability and functionality. Authorities like the FDA and EMA have established guidelines to minimize risks associated with contamination, degradation, and other factors that could compromise the therapeutic value of these products. Despite these regulations, the sector faces challenges in consistently meeting these standards, leading to deficiencies that can affect patient safety and treatment outcomes.

Quality control (QC) is another cornerstone in the production of TEMPs, ensuring that these products meet predefined quality criteria and are safe for clinical use. This involves evaluating Critical Quality Attributes (CQA), key product characteristics that must be measured, and conducting rigorous testing of raw materials. The complexity of TEMPs and their components poses significant challenges in QC, requiring sophisticated analytical methods and strategies to assess and ensure their quality throughout the manufacturing process.

Overall, it can be assumed that the development of new TEMPs will continue to progress rapidly over the next few years. However, realizing these potentials requires overcoming specific challenges, including ensuring donor eligibility, managing process changes, adhering to stringent regulatory requirements for transportation and storage, implementing quality control measures, and enhancing biovigilance. By addressing these challenges, the field can continue to advance and provide significant benefits to patients worldwide.

Zielgruppe

This course it intended for all person from
  • design and development of TEMPs
  • manufacturing and process development
  • regulatory authorities
  • research institutions
  • quality assurance and quality control
who have daily contact with TEMPs.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Focus on Tissue: A Multidisciplinary Approach - Live Online Training

Gesamtes Programm als PDF herunterladen

TEMPs and their Specific Challenges
  • Specific challenges of TEMPs
  • US donor eligibility for allogeneic donors
  • Process changes
Cell and Tissue Inspections: Regulatory Requirements for Transportation and Storage
  • Authorities' perspective
  • Regulatory requirements for transportation and storage
  • Current deficiencies
Quality Control for TEMPs
  • From CQA to quality control strategy
  • Challenges
  • QC of raw materials
Adverse Reactions and Events
  • Introduction and definition in biovigilance
  • Correct implementation of reporting
  • Examples from daily business

ECA-Member*: € 990,-
Regular Fee*: € 1090,-
EU/GMP Inspectorates*: € 545,-
APIC Member Discount*: € 1040,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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