Quality of active ingredients: technical and regulatory issues.

October 3rd 2008 - Aula VOLTA University of Pavia Strada Nuova 65 27100 Pavia-Italy

Master Biennale di II livello in Discipline Regolatorie "G. Benzi"

Chemical Pharmaceutical Generic Association

Master Universitario in Valutazione e Controllo del Rischio Tossicologico da Inquinanti Ambientali

Legal address:

Dipartimento di Chimica Farmaceutica
Via Taramelli 12 – 27100 – Pavia
Italy
Phone: +39.0382.987583
Fax: +39.0382.422975
E-mail: cda AT ibiocat.eu
Web: www.ibiocat.eu
P.IVA e C.F.: 02221580182

Preliminary Program

Certificate of Suitability at the European Pharmacopoeia and revisions. Mrs
Hélène Bruguera; Deputy Head Certification of Substances Division; EDQM Strasburg (France) Council of Europe

GMP for APIs manufactured by fermentation: Anthracyclines key study. Dr. Fulvio Carlotti, Pfizer Italia, Milano (Italy)

EDQM inspection program. Dr. Isabella Marta, Inspector, Certification of Substances Division; EDQM Strasburg (France) Council of Europe

Sterile products, regulatory aspects and technical controls. Dr. Stefano Oggiano,
ACS Dobfar, Tribiano, Milano (Italy)

Products of fermentation: impact of bioprocess on the quality of chemotherapic drugs. Prof. Marco Terreni, University of Pavia, Italy. Expert for the commission of "Certification Procedure for the chemical purity and microbiological quality evaluation� EDQM Strasburg (France) Council of Europe.

Control of fermentation processes. Prof. Flavia Marinelli, University of Insubria; Varese (Italy).

Scientific Committee (University of Pavia, Italy)

• Prof. Marco Terreni
• Prof. Maurizia Dossena

Program and Registration [Download - PDF file, 247 Kb]:

Regulatory_meeting_2008_2nd_circular.pdf