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Now also available via Online live stream!

In the light of the current outbreak of COVID 19 across Europe, we have prepared an option to accommodate those delegates who will not be allowed to travel. The situation might fully be under control by the time when the training is planned to run, however we want to make sure everyone will get the same chance to take part in this unique training course.

Are you going to be able to attend the course in-person? Fantastic! We are looking forward to meeting you. Will you not be allowed to travel or do you feel it is safer to enjoy this unique course from the luxury of your office or home via your laptop, tablet or mobile? We obviously understand the situation and offer you the opportunity to join us via the online live stream enabling the mutual interaction between you and the trainer.

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

Meet the training leaders

  • Dr. Jörg Engelbergs
  • Regulatory-scientific Expert
  • Paul-Ehrlich-Institut, Germany
Learn more about the trainer
  • Dr. Robert E. Zoubek
  • Senior Consultant
  • Granzer Regulatory Consulting & Services, Germany
Learn more about the trainer

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

Key Takeaways

Learn

  • The principles of regulatory-scientific Quality assessment
  • EMA Guidelines and European Pharmacopeia Monographs
  • Manufacturing process development
  • Formulation development and choice of excipients
  • Batch record review and release methods

Gain

  • Stepwise requirements for process validation
  • Characterization of physicochemical quality attributes
  • Control of Drug Substance and IMPs
  • Best practice: Presentation of the comparability data for the IMPD
  • Quality related aspects of GMP inspections for IMPs

Understand

  • The regulatory landscape for national CTA procedures
  • How the assessors in Europe work
  • Voluntary Harmonized Procedure (VHP) in Europe
  • Quality challenges for Biotech-IMP development
  • Minimal required stability data for phase I to III

Join us in Munich

Munich, the third most populous city in Germany, is famous for its beautiful architecture, fine culture, and the annual Oktoberfest beer celebration. Although it was heavily damaged by allied bombing during World War II, many of its historic buildings have been rebuilt and the city center appears mostly as it did in the late 1800s. Nowadays it is a major international center of business, engineering, research and headquarters of sev-eral multinational companies and worldclass technology and science museums like the Deutsches Muse-um and BMW Museum. It is Germany's most prosperous city and makes it repeatedly into the top 10 of global quality-of-life rankings. Munich represents the balance between the ability to stay at the forefront of technological developments and maintain its cultural heritage.

Ticket

Delegate Fee

from 2596 € Buy

Online Live Stream

from 1596 € Buy

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