WG 4
REGULATORY AND ETHICAL ASPECTS
Leader: Nicola Hofmann (Germany)
Vice Leader: Xavier Lafarge (France)
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:
Dorela Kroni (Albania)
Marcin Jurga (Belgium)
Elma Mrehic' (Bosnia Herzegovina)
Mariastefania Antica (Croatia)
Susanna Miettinen (Finland; STSM Committee Member)
Anna Chioti (Luxembourg)
Andreas Kremer (Luxembourg)
Hanne Scholtz (Norway)
Cecilia Götherström (Sweden)
Volodymyr Shablii (Ukraine)