WG 4
REGULATORY AND ETHICAL ASPECTS

Leader: Nicola Hofmann (Germany)

Vice Leader: Andreas Kremer (Luxembourg)

Aims:

1) To discuss general regulatory issues and specific exemptions for perinatal derivatives (PnD);

2) To set commonly accepted GMP and regulatory standards;

3) To provide an understanding on patient perspectives concerning the collection and use PnD;

4) To discuss with stakeholders, including regulatory agencies, ethical, legal and insurance issues for donation, processing and use of Pn tissues;

5) To guide clinicians for optimal clinical trial design and the successful implementation of efficient and safe clinical trials.

Members:

Marcin Jurga (Belgium)

Elma Mrehic' (Bosnia Herzegovina)
Mariastefania Antica (Croatia)
Susanna Miettinen (Finland; STSM Committee Member)

Anna Chioti (Luxembourg)

Hanne Scholtz (Norway)

Cecilia Götherström (Sweden)

Volodymyr Shablii (Ukraine)

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Funded by the Horizon 2020 Framework Programme of the European Union

© 2019 SPRINT