Titolo del corso
Aspetti Regolatori
Codice identificativo del corso
2223-1002-6
Syllabus del corso
Titolo
REGULATORY ASPECTS
Docente(i)
- Sandra Petraglia
- Maria Elena Trovati
- Annabella Amatulli
- Silvia Mori
Lingua
English
Breve descrizione
COURSE OBJECTIVES
Introduction to the key features relating to the regulatory legislation and the Good Clinical Practices (GCP) principles.
MAIN TOPICS
- Regulatory aspects & legislations: the view of AIFA – 2h Sandra Pedraglia
- Regulatory aspects & legislations: the view of pharma – 2h Maria Elena Trovati
- Regulatory aspects & legislations in the area of rare-diseases – 2h Annabella Amatulli
- Good clinical practices – 2h Silvia Mori
CFU / Ore
1/8
Periodo di erogazione
- July 20th (2h) 17.00-19.00 Petraglia - Streaming
- July 22nd (2h) 17.00-19.00 Mori - Streaming
- July 23rd (2h) 9.00-11.00 Trovati - Streaming
- July 23rd (2h) 11.00-13.00 Amatulli - Streaming
Title
REGULATORY ASPECTS
Teacher(s)
- Sandra Petraglia
- Maria Elena Trovati
- Annabella Amatulli
- Silvia Mori
Language
English
Short description
COURSE OBJECTIVES
Introduction to the key features relating to the regulatory legislation and the Good Clinical Practices (GCP) principles.
MAIN TOPICS
- Regulatory aspects & legislations: the view of AIFA – 2h Sandra Pedraglia
- Regulatory aspects & legislations: the view of pharma – 2h Maria Elena Trovati
- Regulatory aspects & legislations in the area of rare-diseases – 2h Annabella Amatulli
- Good clinical practices – 2h Silvia Mori
CFU / Hours
1/8
Teaching period
- July 20th (2h) 17.00-19.00 Petraglia - Streaming
- July 22nd (2h) 17.00-19.00 Mori - Streaming
- July 23rd (2h) 9.00-11.00 Trovati - Streaming
- July 23rd (2h) 11.00-13.00 Amatulli - Streaming