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Printable Handouts
Navigable Slide Index
- Introduction
- Outline
- No reproductive borders
- Objectives
- What the directives apply to
- What the directives deal with
- The directives
- Directive 2004/23/EC
- Competent authority & procurement and testing
- Traceability
- Import-export to third parties & register of TE
- Report, donation, consent and confidentiality
- Quality management
- System of TC identification
- Notification of SAR-SAE
- TE’s must have a QMS
- Person responsible
- Personnel
- TC reception
- TC processing & TC storage
- Relationships with third parties
- First directive - summary
- Directive 2006/17/EC
- Tissue establishments & competent authorities
- ART definitions
- Procurement (Art 2)
- Directive 2006/17/EC 2- annex III: partner donation
- Annex III: non-partner donation
- Directive 2006/17/EC 2- annex IV
- Second directive - summary
- Directive 2006/86/EC
- What directive 2006/86/EC apply to
- Article 3: organisation
- Article 3: personnel
- Article 3: equipment and materials
- Article 3: facilities and premises
- Article 3: documentation and records/quality review
- Article 4 (preparation)
- Preparation process
- Serious adverse reactions
- Notification of serious adverse reactions form
- Conclusions of serious adverse reactions form
- Serious adverse event
- Notification of serious adverse event form
- Conclusions of serious adverse event form
- Articles 5 and 6 (notification of SARE)
- Article 7 (annual report)
- Annual notification format: part A
- Annual notification format: part B
- Article 8
- Articles 9 & 10 (traceability & coding)
- Traceability
- What member states must establish
- Competent authorities
- Tissue establishments
- Unique code
- Acknowledgements
Topics Covered
- Regulation objectives
- The directives
- 2004/23/EC: standards of quality and safety
- 2006/17/EC: technical requirements for the donation, procurement and testing of human tissues and cells
- 2006/86/EC: traceability, notification of serious adverse reactions and events & technical requirements
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Mocanu, E. (2015, August 31). Regulation of assisted reproduction under the European Union tissues and cells directives [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 21, 2024, from https://doi.org/10.69645/NGPT4700.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Edgar Mocanu has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Other Talks in the Series: Tissue in Research
Transcript
Please wait while the transcript is being prepared...
0:00
EDGAR MOCANU: I'm Edgar
Mocanu, consultant
obstetrician and gynecologist at
the Rotunda Hospital in Dublin.
I'm also the European Society of
Human Reproduction and Embryology
EU TCD task force coordinator.
I'll be talking about the
regulation of assisted reproduction
under the European tissue
and cell directors.
0:25
I will specifically address
the objectives of introducing
regulation in this field and dissect
the three directives, which have
been transposed into law in European
countries. I would like to describe
the specific implications for member
states, for tissue establishments,
and for competent authorities.
0:49
From the beginning,
I would like to acknowledge
that ART services have no country
or continental borders at present.
Both patients and reproductive
materials like gametes, embryos,
and frozen issues liberally cross
borders, as do individuals that can
act both as recipients or donors.
This makes the
regulation and quality
assurance of reproductive
tourism a significant task.
1:18
From this perspective,
the European Commission
has introduced the
directives in order
to set standards of
quality and safety
for human tissues
and cells intended
for human medical treatments
and to ensure a high level
of protection of human health.
1:36
While the directives apply to
hermatopoetic peripheral blood,
umbilical cord blood, bone
marrow stem cells, fetal tissues
and cells, embryonic stem
cells, I'll specifically focus
on reproductive cells in my talk.
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