Annual CMC Conference
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
This online-conference addresses quality-related questions from the CTD compilation to quality changes/variations. Take the chance to participate in our virtual conference via Zoom.
Meinungen
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Sämtlich Kurse sind auf dem neuesten Stand
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Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Inhalte
Detailed programme
9:00 am - 5:00 pm Online-Conference
09:00
Dr Mónica Unger-Bady (Chair day one)
Welcome and introduction
09:15
Dr Blanka Hirschlerová
Update from the Quality Working Party - current topics in 2020
- Which guidelines, recommendations, etc. are under review?
10:45 Coffee break
11:15
Dr Heike Volkmer
CMC requirements especially for new excipients - focus biological products
- Legal aspects and regulations in Europe and USA
- Overall strategic considerations will impact submission and business timelines
- Regulatory requirements guide the development of new excipients
- Excipient risk assessment defines the CMC data package
- Do's and don'ts for new excipients development
12:45 Lunch break
14:15
Andrew McMath
Nitrosamines impurities: Current status and expectations
- Recap of the root cause
- Actions taken by EDQM, Impact on the Ph Eur
- Nitrosamines in APIs
- The lessons learned exercise: The different aspects including OMCLs
15:15 Coffee break
15:45
Dr Monica Unger-Bady
Outsourcing Regulatory Affairs
- Distinguishing between different types of outsourcing (pros and cons)
- Defining requirement specifications
- Preparing internal structures and interfaces
16:45 Concluding discussion
17:00 End of day one
09:00
Kevin O'Donnell, PhD
Revision ICH Q9: Quality Risk Management
- Main changes and challenges
- Implementation in the EU
10:45 Coffee break
11:15
Dr Christina Juli
Global CMC requirements - The Asia Pacific Region
- Specific CMC requirements in non-EU countries: Asia - focus China, Russia, Japan
- Additional quality data to be generated
- Documentation to be included in regulatory submission dossier in context of CTA, MAA/BLA and post-approval changes
- Practical experiences from industry perspective
12:15 Lunch break
13:45
Dr Katrin Buss
Primary pharmaceutical packaging = applicator: quality requirements towards drug-device combinations from the regulatory point of view
- Definition of DDC
- What's new?
- EMA Guideline on the quality requirements for drug-device combinations
14:45 Coffee break
15:15
Dr Cornelia Nopitsch-Mai (Chair day two)
Workshop: Variations related hot topics/Acceptability of starting materials
- Quality related changes of the
- API
- manufacturing process
- analytical methods
- Starting Material (with case studies)
16:45 Concluding discussion
17:00 End of conference
Detailed programme
9:00 am - 5:00 pm Online-Conference
09:00
Dr Mónica Unger-Bady (Chair day one)
Welcome and introduction
...
Annual CMC Conference