Definition of starting materials – scientific and regulatory aspects | CN 6697
VenueLeonardo Royal Hotel Frankfurt
Mailänder Straße 1
Phone:+49 69 680 20
Fax:+49 69 6802-888
Workshop programme for download
- 6697 starting materials.pdf(195 K)
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.
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.
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.