- Online training -
Webcode 25022450
Katrin Bräckow
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
Head of Scientific CMC Documentation Drug Substance & Customer Services Until October 2021, Anne Katrin Bräckow initially held various quality functions in CMC (including as CMC Expert Operations) and Change Control Management at Boehringer Ingelheim Pharma GmbH & Co. KG. Since October 2021, she has been leading the divisional CMC Writing Team, which deals with document creation for NCEs' API dossiers.
Dr. Christina Juli
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Head of CMC Management CMB Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined the ratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working in the Tech RA department at Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of CMC Management CMB, she focuses on the CMC development for biologics and is responsible for the definition, compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups).
Nora Wild
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, GERMANY
Head of Scientific CMC Documentation DP Nora is a biologist. Her professional career started by a consultancy in Germany in 2004. From 2007 to 2010 she worked at Abbott as a manager in quality assurance. From 2010 to 2011she worked as a manager at Wilmar Schwabe in CMC and regulatory department. After this period she joined again Abbott from 2011 to 2017 again in quality assurance. From 2017 to 2023 she worked as a senior manager in CMC regulatory at Pharmalex. Nora joined Boehringer Ingelheim in 2024 and has been working in the CMC Management Department as head of scientific CMC documentation DP. She and her team are responsible for the content of CMC documents (Module 3) of the regulatory submission documentation for Drug Product. The CMC documentation is harmonized across products and sites and complies with the latest scientific and regulatory findings.
18/02/2025
18/02/2025
9:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.
Our training will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.
After an introduction on the general structure and presentation of CMC documents in Module 3 and Module 2, our experts will dive deeper into different relevant CTD sections sharing practical examples and their experiences with you.
You will learn about the specific requirements for NCEs and generics.
Furthermore our experts will address details on country specific CMC documents.
After attending the seminar you will be able to present data clearly and in compliance with the regulations, and you will be able to sew a "golden thread" through your CMC documents.
Profit from the in-depth know-how and the practical examples that our four experts will share with you! Develop a guideline to efficiently manage the challenges in your own daily business! Feel more secure writing CMC documents!
09:00 Welcome, expectations, introduction
09:15
All experts
10:15 Biobreak
10:30
All experts
12:00 Lunch break
13:00
All experts
14:30 Biobreak
14:45
All experts
15:45
All experts
16:30 Summary and outstanding questions
17:00 End of seminar
This course can be choosen as an elective module within the modular qualification course "CMC-Specialist in Regulatory Affairs".
The concept:
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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