Making science workFind out how

Making science work

Find out how

Definition of starting materials – scientific and regulatory aspects  | CN 6697

08.11.2017 | Frankfurt/Main, Germany

Venue

Leonardo Royal Hotel Frankfurt
Mailänder 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

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 €
All prices free of VAT

Organizer(s)

APV-Office

Dr. Martin Bornhöft
Phone: +49 6131 9769-0
Fax: +49 6131 9769-69
E-mail: apv@apv-mainz.de
www: http://www.apv-mainz.de/