Definition of starting materials – scientific and regulatory aspects | CN 6697
Venue
Leonardo Royal Hotel FrankfurtMailänder Straße 1
60598 Frankfurt/Main
Phone:+49 69 680 20
Fax:+49 69 6802-888
E-mail:res.royalfrm@leonardo-hotels.com
Workshop programme for download
- 6697 starting materials.pdf(195 K)
Target groups
This seminar addresses pharmaceutical professionals in R&D as well as in quality control/assurance and regulatory affairs departments of pharma-ceutical industry and API manufacturers.
Objective
This seminar covers all relevant aspects concerning the definition of starting materials:
• ICH Q11 and other relevant guidelines
• Requirements from authority’s perspective
• Experiences after submissions and consequences for drug substance
development and lifecycle management
• Scientific data in regulatory submissions
• Starting materials for biologicals
Take advantage to discuss with colleagues from pharmaceutical industry,
API manufacturer and authorities.
Speaker
Philipp Huber, PhD
Philipp Huber, PhD is pharmacist, food chemist and toxicologist. He has
15 years of experience in the area of quality control/assurance and CMC regulatory affairs. He is currently working as Head of Quality Excellence,
Dept. Quality for Boehringer Ingelheim in Ingelheim, Germany.
Registration fee
| Price | |
|---|---|
| Industry | 990.00 € |
| Authorities/University | 495.00 € |
| Students | 178.00 € |
Organizer(s)
APV-Office
Dr. Martin Bornhöft
Phone: +49 6131 9769-0
Fax: +49 6131 9769-69
E-mail: apv@apv-mainz.de
www: https://www.apv-mainz.de/