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2012279 PharmaFORUM Webcast Biologics
PharmaFORUM
Webcast Biologics
2020-01-23 2020-01-23 Online Online

PharmaFORUM Webcast Biologics

"ICH Q14 and revision ICH Q2" 3 December 2020

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Topics
  • ICH Q14: a new Quality Guideline on Analytical Procedure Development
  • ICH Q2(R1): revision of the Guideline on Validation of Analytical Procedures
  • Harmonisation of the scientific approaches of analytical procedure development
  • Provision of the principles relating to the description of the analytical procedure development process

Aims and objectives

Do you work with biologics? Then, we would like to invite you to join our live webcast series.
Industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs (pre- and post-authorisation phases) of biologics every monthly. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.
You will meet our experts in a virtual conference room and share your experiences live. Each meeting will be held as a 1.5 to 2-hour webcast, presenting the latest news with supporting presentation slides. To be best prepared, you will be able to download the complete presentation documents prior to each webcast.
Are you unable to attend one of the webcasts? No problem! Following each live meeting, you will be able to retrieve the recorded webcast (audio track and presentation) from our eLearning Centre, using your personal password. This allows you to review each presentation at any time and as often as you like.
Who should attend
This webcast series addresses the needs of managers in the biopharmaceutical industry needing to keep up to date with development, quality, analytics and regulatory affairs, in particular with CMC related topics.
Your Speaker
Dr. René Thürmer
-requested- Expert for Pharmaceutical Quality, Bonn, Germany


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