Strategic Approaches and Operational Excellence for Regulatory Affairs Manager
Webcode 24102502
Dr. Peter Bachmann
Senior Expert Regulatory Affairs, Bonn
Dr. Bachmann served for many years at the BfArM as a head of department in the European and International Affairs unit. He made a significant contribution to establishing the European DCP system.
Franziska Dukatz
Deloitte GmbH, Berlin
Senior Manager, Regulatory & Compliance; Franziska Dukatz is a Senior Manager in Deloitte's Risk Advisory Practice, specializing in Regulatory Risk and Compliance. She is a Life Sciences expert and consults Pharma and MedTech companies since 10 years. Her clients operate in highly regulated environments and continuously aim to improve their performance while ensuring compliance. Franziska and her team support them on their digital transformation journey, as well as with remediation and process improvement programs. For Regulatory Affairs specifically, Franziska leads projects around new regulation readiness, regulatory information management & systems implementations, as well as regulatory operations support.
Dr. Isabelle Stöckert
Bayer AG, Wuppertal
VP, Senior Advisor Regulatory Affairs; Dr. Stöckert has extensive experience in global pharmaceutical development, collaborating closely with the FDA and EMA.
09-10/10/2024
09-10/10/2024
Tag 1: 09:00 - 17:00 Uhr
Tag 2: 09:00 - 14:30 Uhr
online
online
Veranstaltung - 1,590 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting.
Veranstaltung - 1,590 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.
The aim of this seminar is to provide you with a comprehensive understanding of both the strategic and operational aspects of global regulatory affairs. The seminar will focus on worldwide Regulatory roll out of therapeutic innovations and the importance of aligning regulatory affairs with market access strategies to achieve optimal market acceptance. You will learn how to efficiently manage the creation and maintenance of regulatory dossiers while keeping pace with global trends and collaborative programs.
After the seminar, you will
08:45 Day one
09:15
Dr. Isabelle Stöckert
11:00
Franziska Dukatz, Dr. Isabelle Stöckert
13:00
Dr. Isabelle Stöckert
14:00
Dr. Peter Bachmann, Dr. Isabelle Stöckert
15:15 Workshop: Case Studies
16:00
Dr. Peter Bachmann
16:45 Q&A
08:45 Day two
09:10
Franziska Dukatz
10:30
Franziska Dukatz, Dr. Isabelle Stöckert
11:25
Dr. Isabelle Stöckert
13:00
Dr. Peter Bachmann, Dr. Isabelle Stöckert
Are you interested in an in-house training on the topic "Global Regulatory Affairs Manager"? Please contact us for more information.
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The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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