- Online training -
Webcode 22102450
Dr. Margit Schnee
Vifor Pharma
Regulatory Affairs Manager CMC
André Mota
ASPHALION S.L., Madrid Office, Spain
Regulatory Affairs Director;
André has more than 14 years' experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different countries, with several types products, and for different types of companies.
Besides his core CMC expertise, mainly focused on CMC writing and strategic guidance, he has also been deeply involved in other relevant areas, such as:
- Project lead/management of global projects
- Implementation of EMA Policy 0070 (clinical data transparency)
- eCTD publishing
More information please click here.
Dr. Helmut Vigenschow
ViPharmaService, Burgrieden
Keine ausführliche englische Beschreibung vorhanden
13. - 14.10.2022
13. - 14.10.2022
Day 1: 9:00 am - 5:00 pmDay 2: 9:00 ...
Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm
online
online
Event - 1.790,- € plus tax
The fee includes course documentation for download and a certificate.
Event - 1.790,- € plus tax
The fee includes course documentation for download and a certificate.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar via Zoom.
This online-training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. Our experts will pass on their indepth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.
This seminar will particularly benefit CMC managers, regulatory affairs managers and quality assurance specialists dealing with
the
09:00 Welcome and introduction
09:15
Dr. Margit Schnee
09:45
André Mota and Dr. Margit Schnee
10:45 Coffee break
11:00 Continuation: Quality data for the marketing authorization
12:30 Lunch break
13:30
André Mota and Dr. Margit Schnee
14:45 Coffee break
15:00
André Mota and Dr. Margit Schnee
17:00 End of day 1
09:00
Dr. Margit Schnee
10:15 Coffee break
10:30
Dr Helmut Vigenschow
12:45 Lunch break
13:45
Dr. Margit Schnee
15:00 Coffee break
15:15
Dr Helmut Vigenschow
16:45 Q&As and outstanding questions
17:00 End of training course
- Knowledge of regulatory framework in Europe and the ICH region
- Ability to choose the essential quality data for drug substance and drug product section of Module 3
- CMC writing skills
- Background knowledge in interdisciplinary field: non-clinical, GMP and clinical meets CMC
- Familiarity with life cycle management in a global environment
- The ability to classify quality-related changes
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions during the seminar.
Please send your questions to: Dr. Birgit Wessels, b.wessels@forum-institut.de
Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.
1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.
Overall impression: 100 % of the participants feedback was very good or good (September 2019)
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Comment of September 2019
Helpful and recommendable
Dr. Jelena Dimitrijevic
Glenwood GmbH
