- Online training -
Webcode 23112453
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics" in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunsera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.
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
14/11/2023
14/11/2023
9:00 am - 5:00 pm online seminarYou ...
9:00 am - 5:00 pm online seminar
You may dial in 30 minutes before the training starts
online
online
Event - 1,150 € plus tax
The fee includes course documentation for download as well as a certificate.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a € 50 discount on the e-learning programme (€ 340 + local VAT rather than € 390 + local VAT) if you book it simultaneously.
340,00 €
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a € 50 discount on the e-learning programme (€ 340 + local VAT rather than € 390 + local VAT) if you book it simultaneously.
340,00 €
Event - 1,150 € plus tax
The fee includes course documentation for download as well as a certificate.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a € 50 discount on the e-learning programme (€ 340 + local VAT rather than € 390 + local VAT) if you book it simultaneously.
340,00 €
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a € 50 discount on the e-learning programme (€ 340 + local VAT rather than € 390 + local VAT) if you book it simultaneously.
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 as a lifecycle manager 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 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
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.
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
Get to know our Learning Space and gain confidence: You can attend one of our one of our PreMeetings free of charge, registration is not required. Dates and access data for our PreMeetings can be found in your customer account. A PreMeeting offers the opportunity to get to know our Learning Space better. It is a non-binding offer for all customers and is not a prerequisite for your participation. If no date of a PreMeeting does not suit you, but you would like a technical check in advance, please contact us. please do not hesitate to contact us.
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