PharmaFORUM Webcast Biologics
"ICH Q14 and revision ICH Q2" 3 December 2020
- 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 objectivesDo 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.
Find all the details regarding the programme, experts and technical requirements at
- Twelve live webcasts with international experts per year
- Recorded webcasts at our e-Learning Centre to review as often as you like
- Documentation for your to download
- Multiple-choice test after each webcast to obtain a personal certificate
Dieses Seminar informiert Sie über Quality Assurance/Analytik-Anforderungen an Primärpackmitteln ebenso wie über Regulatory Affairs-Aspekte. Kommende Anforderungen an Drug-Device-Kombinationen (Packmittel als Applikator) werden ebenfalls adressiert.
05.03.2020 in Frankfurt am Main
Seminar mit Fokus: Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige?
28. - 29.01.2020 in Bonn
In diesem Seminar erfahren Sie, wie Sie gewährleisten, dass Ihre Zulassungsunterlagen stets dem aktuellen Profil Ihres Arzneimittels entsprechen, notwendige Anpassungen zeitnah erfolgen und so Regulatory Compliance zu jeder Zeit sichergestellt ist!
30. - 31.01.2020 in Frankfurt
This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
13.02.2020 in Frankfurt
This course provides you with sound knowledge in dealing with the registration and distribution of medical devices in Russia, Belarus, Kazakhstan and many other countries.
27.02.2020 in Frankfurt-Raunheim