FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505

Modular online qualification course „Development Expert Biologics“

Do you work with biologics? Our modular online qualification course will provide you with an in-depth knowledge on the current challenges in the development of biologics (analytics, quality, safety) according to your needs.
 

Your benefits at a glance

  • Modular online training tailored to your needs
  • One e-Learning and choice of three webcast modules according to your needs
  • Learn at your own pace – wherever and whenever you want
  • Pass the online multiple-choice test for each training module and receive a certificate
  • Pay 25% less with this package

Programme content in detail

1) Commencement of training

Webcast Interaction with Agencies
  • National 'versus' EMA Scientific Advice
  • How to strategically plan interaction with authorities
  • What to expect from the interaction
Webcast by Dr Christian Schneider 10/2018
 

2) Choice of two webcasts from our PharmaFORUM Webcast Biologics series, which you can freely choose from the following according to your field of interest:


QbD elements in early and late stage biotherapeutic development
(from research to first in human until commercial)
  • Implementation of QbD elements
  • Quality attributes / critical quality attributes
  • Quality target product profile (QTPP)
  • Comparability studies
Webcast by Dr Dorothée Ambrosius 11/2018

Analytical development concepts to guide CMC development
  • Current analytical methods
  • Specification and validation
  • Developmental vs. CMC data
Webcast by Dr René Thürmer 01/2019

Cell line development
  • Host cells
  • State-of-the-art cell line generation process
  • Importance of monoclonality assurance
  • Bioreactor assessment
  • Phenotypic & genotypic stability
Webcast by Dr Simon Fischer 02/2019

Virus safety
  • Potential sources of virus contamination
  • Cell line qualification: testing for viruses
  • Testing for viruses in unprocessed bulk
  • Virus validation studies
Webcast by Dr Barbara Enenkel and Sabine Häcker 03/2019

Upstream development
  • Process characterization
  • Fermentation development
  • Scale-up and scale-down approaches
Webcast coming soon by Dr Markus Michael Müller 04/2019
 

3) e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region. It will provide you with an understanding of the chemical, physical and microbiological factors influencing stability testing, and an in-depth knowledge of stability study requirements.
 

4) Completion

Once you have successfully completed all the modules and tests you receive  the ‘Development Expert Biologics’ certificate.
 

Fee

The fee for a single account, which is valid for 12 months, is € 990 (excluding German VAT). You may access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
 

FREE demo account

Try out our ‘Stability Testing in the ICH Region’ e-learning programme for free and familiarise yourself with our learning environment.
 
Auszeichnungen und Kooperationspartner
 
 

CONTACT & QUESTIONS

Dr Birgit Wessels

Conference Manager Pharma & Healthcare

+49 6221 500-655

b.wessels@forum-institut.de