- Online training -
Webcode 24022451
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 Würzburg, 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 at the manufacturing site for biopharmaceuticals of 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.
Dr. Jakob Engel
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Head of CMC Expert Office II Dr Jakob Engel has been leading a team of Technical Regulatory Affairs Managers and CMC experts at Boehringer Ingelheim since May 2021, focusing on the preparation of CTD Module 3 documentation for the registration and lifecycle management of biopharmaceutical products. He has been involved in CMC development and regulatory affairs of biopharmaceuticals for many years and has held positions in analytical development, among others.
Joel Walderbach
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
Head of Chromatographic Special Technology Joel started his training as a chemical lab assistant at Boehringer Ingelheim in Sep/2004. After his training, he worked in the department Analytical Development Germany/Late stage drug substance analysis from Jul/2007 until Jun/2013. From Oct/2008 until Mai/2015, Joel studied Chemical Engineering (B.Sc. and M.Sc.) at the Provadis School of International Management and Technology. He joined his former position in CMC Management in July/2013 and was responsible for various products and held different positions. He and his team were responsible for the content of CMC documents (Module 3) of the regulatory submission documentation. The documentation is harmonized across products and sites and complies with the latest scientific and regulatory findings.
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.
07/02/2024
07/02/2024
9:00 am - 5:00 pm - online seminarYo...
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 the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
SPECIAL OFFERS
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 €
e-Learning: CTD Module 3
, 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 the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
SPECIAL OFFERS
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 €
e-Learning: CTD Module 3
, 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
You 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 small and for large molecules.
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
10:15 Coffee break
10:30
12:00 Lunch break
13:00
14:30 Coffee break
14:45
15:45
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:
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
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.
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
Dieses Seminar macht Sie regulatorisch fit in Sachen Packungsbeilage, Artworkmanagement und Qualitätskontrolle/Audit/Ins...
Online-Seminar mit Fokus: Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige?
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
Welche Literatur muss gescreent werden und welche Informationen müssen gesammelt werden? In diesem Online-Seminar erhalt...
Das Online PHARMA FORUM bietet seit vielen Jahren die Möglichkeit, sich einmal pro Monat über das Internet in den Themen...
