- Online-training -
Webcode 25092450
Dr. Cornelia Nopitsch-Mai
Expert pharmaceutical quality and regulatory affairs, GERMANY
From 1991 till 2023 she was scientist at the Federal Institute for Drugs and Medical Devices in the assessment of the quality of the dossier and is experienced in the assessment of pharmaceutical dossiers for marketing authorisation applications of medicinal products. She has broad knowledge of the national and EU regulations of medicinal products as well as of the corresponding EU guidelines and the European Pharmacopoeia. Since 2000 she was assessor for the Certification Procedure (EDQM) in Strasbourg. She was member of the Technical Advisory Board (TAB) from 2001 to 2010, chairperson of the TAB from 2005 to 2010 as well as member of the Quality Working Party from October 2007 to February 2011.
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.
Dr. Henrietta Dehmlow
F. Hoffmann La Roche AG, Basel, SWITZERLAND
Head of Submission Management Small Molecules Basel
Dr. Lisa Matzen
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY
Head of Global CMC Regulatory Affairs
22-23/09/2025
22-23/09/2025
Day 1: 09:00 am till 05:00 pm
Day 2: 09:00 am till 12:00 pm
You may dial-in 30 minutes before the session starts
online
online
Veranstaltung - 1,690 € zzgl. MwSt.
The participation fee incl. documentation for download, a certificate, access to the Learning Space and technical support incl. PreMeeting.
Veranstaltung - 1,690 € zzgl. MwSt.
The participation fee incl. documentation for download, a certificate, access to the Learning Space and technical support incl. PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!
After the seminar, you will know the requirements for the presentation of quality data of active pharmaceutical ingredients (APIs) in the dossier in Europe and the USA. You will also be familiar with the presentation in the ASMF, CEP and US-DMF.
You will be able to assess the suitability of an API Starting Material and draw conclusions from common misinterpretations in case studies. You will also be able to put the regulatory requirements for the impurity profile into practice.
You will have received strategic tips for your CMC writing and will be able to distinguish between GMP-relevant and dossier-relevant data. You plan your Scientific Advice Meetings sensibly and purposefully.
You will have learned what to consider when submitting change notifications for active substances and know what to look out for in the country-specific mandatory eSubmission.
You will have been trained on how to successfully manage the regulatory lifecycle for APIs in Europe and beyond, e.g. Brazil, Russia, China, Japan, including a short excursion on new regulatory trends including ICH Q12, reliance and AI.
Based on their diverse know-how, our four experienced experts will give you valuable tips, highlight critical aspects and point out what is ultimately relevant for your CMC dossier. The focus is on the EU and US requirements, but the non-EU special features in the change control procedure are also discussed. Profit from the new excursion on regulatory trends including ICH Q12, reliance and AI, too.
Dr Cornelia Nopitsch-Mai
Biobreak
Dr Helmut Vigenschow
Lunch break
Dr Helmut Vigenschow
Dr Cornelia Nopitsch-Mai
Biobreak
Dr Helmut Vigenschow
Recap and outstanding questions
End of seminar day 1
Dr Henrietta Dehmlow
Biobreak
Dr Lisa Matzen
End of the seminar
This seminar can be taken as an elective module as part of our CMC Specialist in Regulatory Affairs qualification course.
The course concept:
- You attend our basic course "The CMC Manager in Regulatory Affairs"
- You then take part in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
- You will receive structured further training and comprehensive knowledge in CMC Regulatory Affairs
- You can specialize through the targeted selection of seminars according to your main area of activity
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