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SCHICHTEL Dr. Julian
Main PRRC for:
Art. 15 (EU)2017/745
Contact to EUDAMED, Health Authorities and Notfied Bodies
Main PRRC for:
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – liquid dosage forms)
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SEIMETZ Erik
Deputy PRRC for:
Art. 15(EU) 2017/745
Contact to EUDAMED, Health Authorities and Notfied Bodies
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TASCEDDA Dr. Patricia
Main PRRC for:
Article15, (3)a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – semi-solid dosage forms)
Deputy PRRC for:
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (external processes – quality of externally manufactured products)
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WIEGAND Dr. Christian
Main PRRC for:
Article 15, (3)a) and (3)e, Annex I - IV and Annex XV, Chap. II, 4.1
Check of conformity of manufactured products with QMS and release (internal processes - test medication for clinical trials and external processes – quality of externally manufactured products)
Deputy PPRC for:
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – semi-solid dosage forms and liquid dosage forms)
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STEINMETZ Charlotte
Main PRRC for:
Article 15, (3)c), Art. 80, Art. 83 ff.
Post Market Surveillance
Main PRRC for:
Article 15, (3)d), Art. 80, Art. 87 – 91
Vigilance Reporting
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GROSS Dorothea
Deputy PRRC for:
Article 15, (3)c), Art. 80, Art. 83 ff.
Post Market Surveillance
Deputy PRRC for:
Article 15, (3)d), Art. 80, Art. 87 – 91
Vigilance Reporting
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STEIN Michaela
Main PRRC for:
Article 15, (3)b), Annex I - IV
Check of conformity of Technical Documentation with the requirements of Annexes II and III of MDR
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RÖCKER Katja
Deputy PRRC for:
Article 15, (3)b), Annex I - IV
Check of conformity of Technical Documentation with the requirements of Annexes II and III of MDR
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MAHLER Markus
Deputy PPRC for (only in absence of Dr. Julian Schichtel and Dr. Christian Wiegand):
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – liquid dosage forms)
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SCHMITZ-ESSER Jörg
Deputy PPRC for (only in absence of Dr. Julian Schichtel and Dr. Christian Wiegand):
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – liquid dosage forms)
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