Meet the training leaders
- Dr. Jörg Engelbergs
- Regulatory-scientific Expert
- Paul-Ehrlich-Institut, Germany
- Dr. Robert E. Zoubek
- Senior Consultant
- Granzer Regulatory Consulting & Services, Germany
Key Topics
Manufacturing of the Drug Substance and IMP
Requirements for process validation
IMPs comparators and placebos
Release specifications versus In-Process Controls, ICH guidelines
Analytical methods throughout clinical development, Batch data
The site master file (SMF)
Manufacturing process changes during clinical development
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events