It comprises the minimum essential information for each nuclear medicine concept represented by a single term. It provides the reader with the information required to approach this multidisciplinary speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate communication and promote common understanding.

Scope

This Handbook provides guidance on what a digital hospital is and proposes a set of principles (in Section 3) that provide the basis for the development of a Digital Hospital Program.
Sections 5 to 9 of this Handbook set out the key phases required to deliver a digital hospital—from business case through design, implementation, go-live and finally, to handover—that take place in a Digital Hospital Program. Throughout the program are foundations or themes that should be considered and established at the onset and thereafter require a continuous focus; the breadth and depth of focus on each theme or foundation may vary but should be commensurate with the stage of the program.

1. contamination by bacteria, moulds or yeasts;

2. contamination by viruses;

3. contamination by agents causing transmissible spongiform encephalopathies (TSE);

4. material responsible for undesired pyrogenic, immunological or toxicological reactions.

For parasites and other unclassified pathogenic entities, similar principles can apply.

This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

This document does not specify a quality management system for the control of all stages of production of medical devices.

This document does not cover the utilization of human tissues in medical devices.

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This PAS also includes guidance on identifying, assessing and controlling risks to patients associated with materials of biological origin.

This PAS covers the evaluation of all materials of biological origin that come into contact with the cellular active substance.

This PAS focuses primarily on materials of human and animal origin and their potential impurities and contaminants. However, reagents derived from diverse biological sources including plants, insects and marine organisms are also used in the development of cell-based medicinal products. Therefore the fundamental principles of risk management also apply for these materials.

This PAS also covers legislation for cell-based medicinal products and is intended for developers who wish to undertake clinical trials and/or license products in both the EU and the US.

This PAS does not cover the selection, assessment or control of cellular active substances, nor the starting materials as defined in Directive 2001/83/EC [1] and excipients. However, it is anticipated that these are still covered by general risk management procedures.

This PAS does not cover biological materials that are used in the development of any other biological medicinal product.

This PAS is applicable for product developers at all stages of development; however maximum benefits can be gained by the implementation of recommendations in this PAS in the early stages of development.

This PAS is intended for use by organizations and individuals with an interest in the development of cell-based medicinal products for clinical applications.

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1. associated with the naming of types of cell therapy and regenerative medicine products; and

2. that describe materials, processes, methodologies and applications within cell therapies and regenerative medicine.

It covers:

1. general terms;

2. cell and tissue components;

3. non-cellular components;

4. cell and tissue procurement;

5. measurement and analysis;

6. manufacturing and production; and

7. clinical trials.

Alternative definitions of terms found in regulations relevant to the cell therapy and regenerative medicine industry are covered in Annex A.

Finance terms and definitions relevant to the cell therapy and regenerative medicine industry are covered in Annex B.

This PAS will act as a guide to point users in the direction of the relevant EU and US legislation, guidance documents, pharmacopoeial chapters and monographs.

NOTE 1 Since the implementation of EU Directives varies between Member States it is not possible to provide specific national details of how legislation is enacted around the EU.

NOTE 2 Where national differences exist this will be indicated in the text.

This PAS is intended for use by organizations and individuals with an interest in the development of human cells for clinical applications including academic groups, small and medium sized enterprises (SMEs) and larger industrial manufacturers and the general public.

For researchers new to the field, this PAS will give an appreciation of the level of regulation, guidance and associated quality issues that apply to cell therapy products.

This PAS does not cover:

• solid organ transplantation or blood transfusions;
• blood products (e.g. serum, plasma, erythrocytes and platelets);
• xenogeneic products and xenogeneic feeder cells, although much of the text will be broadly applicable;
• combination products, although the text will still be applicable to the cellular component, other requirements will also apply;
• tissue and cell products regulated in the US as devices (e.g. requiring PMA), although much of the text will be broadly applicable to the cellular component, other requirements will also apply;
• genetically modified cell or tissues products, although the text will still be applicable to the cellular component other requirements will also apply;

but for clarity, their relationship to the overall process map is included where useful.

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