- Online training -
Webcode 24112457
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen
Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for marketing authorisation applications, scientific advices and clinical trial applications.
André Mota
ASPHALION S.L., Madrid Office, Spain
Regulatory Affairs Director,
Madrid Office
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 of products, and for different types of companies.
Besides his core CMC expertise, he is 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), and
- eCTD publishing.
More information please click here.
Dr. Helmut Vigenschow
ViPharmaService, Burgrieden
Independent Consultant Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs, pharmaceutical development, quality assurance and quality control. Dr Vigenschow has been working as an independent consultant for several years now.
28/11/2024
28/11/2024
9:00 am - 5:00 pm online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.
You are involved in product lifecycle management processes? Stop asking if Quality by Design is mandatory or needed! Our three experts will sensitise you not to underestimate any longer what you can in fact get from it.
To make the most of ICH Q12 opportunities you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. It's absolutely critical that you understand the need of mastering the different Quality by Design (QbD) options and that you realise their implications.
Our experts will go through each guideline with focus on ICH Q8 (drug product) and ICH Q11 (drug substance). They will point out the specific challenges with interpretation and implementation and the relation between all guidelines.
In the end you will be trained in a more conceptional way on the desired outcome of mastering QbD to make the most of ICH Q12.
After participating in this seminar you will be aware of the relation between the guidelines ICH Q8 to ICH Q12. This will enable you to recognise the opportunities of ICH Q12 and to profitably put the requirements of the guideline into practice.
09:00 Opening and introduction round
09:15
Dr. Steffen Groß
09:45
Dr. Steffen Groß
10:20 Coffee break
10:30
André Mota
12:30 Lunch break
13:30
Dr. Helmut Vigenschow
15:00
Dr. Helmut Vigenschow
16:15 Coffee break
16:30
Dr Steffen Groß and André Mota
17:00 End of the training
Seit 2000 bieten wir Expertenwissen zu verschiedenen Rechtsthemen in englischer und deutscher Sprache an. Zu unseren Kernkompetenzen gehören u.a. das Stoff- und Chemikalienrecht sowie das Pharmarecht.
Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.
This course can be choosen as elective module within the modular qualification training course "CMC-Specialist in Regulatory Affairs".
The concept:
- First you visit the mandatory module "Der CMC-Manager in Regulatory Affairs"
- Further you choose another three elective modules (= three training days) dealing with CMC related topics from our portfolio
- Thus you receive a structured training in CMC/Regulatory Affairs topics
- Thus you are able to qualify yourself individually according to your focus of activities
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