Strategic Approaches and Operational Excellence for Regulatory Affairs Manager
Webcode 25032500
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.
10-11/03/2025
10-11/03/2025
Tag 1: 09:00 - 17:00 Uhr
Tag 2: 09:00 - 14:30 Uhr
online
online
Event - 1,690 € plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting.
Event - 1,690 € plus tax
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
09:00
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
16:00
Dr. Peter Bachmann
16:45 Q&A
09:00
09:10
Franziska Dukatz
10:30
Franziska Dukatz, Dr. Isabelle Stöckert
11:25
Dr. Peter Bachmann, 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.
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
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.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submi...
CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half d...
Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and b...
To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how...
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
