Understanding and applying new regulatory developments - from stability to ICH M4Q (R2)
Webcode 26112454
Marcus Savsek
- requested - Expert for Pharmaceutical Quality & Pharmacokinetics, Bonn, GERMANY
After studying pharmacy, Marcus Savsek worked in the development department of Madaus AG. Since 2001, he has been an assessor for the approval of chemically defined medicinal products and, since 2018, has been deputy head of department in the Neurology, Psychiatry and Ophthalmology Department at the Federal Institute for Drugs and Medical Devices in Bonn. For many years, he has been an expert and trainer on regulatory topics related to pharmaceutical quality and pharmacokinetics, has been involved in the preparation of relevant guidelines, and holds a lectureship at the University of Nicosia.
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.
25/11/2026
25/11/2026
from 9:00 am until 05:00 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.
How do you keep track of the numerous guideline changes?
This seminar provides you with a compact, understandable overview of current and upcoming revisions in the CMC environment and saves you valuable time when analysing new requirements. You will recognise regulatory changes early on so that you can plan strategically.
With practical case studies and direct implementation aids for guidelines such as ICH M4Q(R2) and the new Variation Regulation, you will strengthen your confidence in the regulatory environment.
09:00 Welcome, introduction, expectations
09:15
Marcus Savsek
09:45
Dr Helmut Vigenschow
11:15
11:30
Marcus Savsek
12:15 Lunch break
13:00
Dr Helmut Vigenschow
13:50
14:00
Marcus Savsek
15:20
15:30
Dr Helmut Vigenschow
16:15
Dr Helmut Vigenschow
16:45
17:00
This seminar is the basic module of our qualification programme "CMC-Specialist".
The course concept:
You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!
We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.
We will be happy to send you a non-binding offer.
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
of 5 stars of all ratings from 2025
of 5 stars on Trustpilot = good
This seminar provides newcomers and career changers with a comprehensive introduction to European medical device regulat...
- Registration possible until 09.03.26 - Are you new to pharmacovigilance and looking to kick-start your career? Then th...
We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documenta...
- Registration possible until 17.02.26 - This two-day online course strengthens your skills in writing key pharmacovigil...
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with...
Stay ahead of proposed regulatory changes in pharmaceutical stability testing. This "practical guide" helps you navigate...
Details
Our modular qualification courses top seminars, flexible selection and cost savings.
Details
More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.
Details
