Current Guideline Revisions in CMC
Understanding and applying new regulatory developments - from stability to ICH M4Q (R2)
- Update (Draft) ICH Q1, (Draft) ICH M4Q(R2), Variation Regulation, and more
- Practical knowledge for direct implementation
- Regulatory intelligence
- Officially certified: ISO 9001 + 2101
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 05:00 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 05:00 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
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.
Your speakers
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…
Your speaker
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,…
Your speaker
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.
What to Expect
- Revision planning for ICH guidelines and update on the current status
- Revision of the Variation Regulation
- New CTD structure for the quality dossier: ICH M4Q (R2), implementation in practice
- Update on the innovations introduced by ICH Q1 and ICH M13B + M13A
- Draft ICH Q3E and Concept Paper ICH 6A/B
- "Regulatory Intelligence": How can RA/CMC prepare for the innovations?
Who Should Attend
The seminar offers practical knowledge for
- CMC Managers
- Regulatory Affairs Professionals and
- Quality Managers,
who want to strategically prepare for upcoming regulatory requirements in drug development/approval.
Objective of the Event
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.
Your Benefit
- You'll receive a "practical roadmap" with implementation timelines (where already communicated) and priorities.
- You'll learn applicable strategies from proven practical examples.
- You'll gain compliance certainty with new guidelines.
- You'll save time thanks to complex content presented in an easy-to-understand way.
- You'll gain a strategic advantage by preparing early for upcoming requirements.
Programme
from 9:00 am until 05:00 pm CET
You may dial in 30 minutes before the session
Marcus Savsek
- Which guidelines are being revised?
- Where do we currently stand?
- Update: Titanium dioxide; nitrosamines and other nitroso compounds
Dr Helmut Vigenschow
- Innovations in the Variation Regulation
- "Classification Guideline": What's changing?
- Ãœberblick zu den wesentlichen Neuerungen und zum Implementierungszeitplan
Marcus Savsek
- Overview of the key innovations and implementation timeline
Dr Helmut Vigenschow
- Practical example: Changes to the current section 3.2.P.2 Pharmaceutical Development
- Practical example: Changes to the documentation on process validation
Marcus Savsek
- ICH Q1: Just a summary of the existing guidelines on stability, or are there also innovations?
- ICH M13B: Strength waiver: Changes to the requirements for dissolution profiles; What deviations in composition are permitted?
- ICH M13A: Significance of the wording for BE studies ("high-risk products")
- Ãœberblick zu den wesentlichen Neuerungen und zum Implementierungszeitplan
Dr Helmut Vigenschow
- ICH Q3E Extractables and Leachables
- ICH Q6 A/B Specifikations
Dr Helmut Vigenschow
Welcome, introduction, expectations
Revision planning for ICH guidelines and update on the current status
Revision planning for ICH guidelines and update on the current status
Marcus Savsek
- Which guidelines are being revised?
- Where do we currently stand?
- Update: Titanium dioxide; nitrosamines and other nitroso compounds
Revision of the Variation Regulation
Revision of the Variation Regulation
Dr Helmut Vigenschow
- Innovations in the Variation Regulation
- "Classification Guideline": What's changing?
Biobreak
Biobreak
- Ãœberblick zu den wesentlichen Neuerungen und zum Implementierungszeitplan
New CTD structure for the quality dossier: ICH M4Q (R2)
New CTD structure for the quality dossier: ICH M4Q (R2)
Marcus Savsek
- Overview of the key innovations and implementation timeline
Lunch break
Implementation of ICH M4Q(R2) in practice
Implementation of ICH M4Q(R2) in practice
Dr Helmut Vigenschow
- Practical example: Changes to the current section 3.2.P.2 Pharmaceutical Development
- Practical example: Changes to the documentation on process validation
Biobreak
Update on the innovations introduced by ICH Q1, ICH M13B + M13A
Update on the innovations introduced by ICH Q1, ICH M13B + M13A
Marcus Savsek
- ICH Q1: Just a summary of the existing guidelines on stability, or are there also innovations?
- ICH M13B: Strength waiver: Changes to the requirements for dissolution profiles; What deviations in composition are permitted?
- ICH M13A: Significance of the wording for BE studies ("high-risk products")
Biobreak
Biobreak
- Ãœberblick zu den wesentlichen Neuerungen und zum Implementierungszeitplan
Draft ICH Q3E and Concept Paper ICH Q6A/B
Draft ICH Q3E and Concept Paper ICH Q6A/B
Dr Helmut Vigenschow
- ICH Q3E Extractables and Leachables
- ICH Q6 A/B Specifikations
"Regulatory Intelligence": How can RA/CMC prepare for the innovations?
Q&As
End of seminar
Downloads
Request the documents using our form.
Brochure
Stability testing of drug products
Weitere Informationen
Qualification course "CMC-Specialist"
This seminar is the basic module of our qualification programme "CMC-Specialist".
The course concept:
- You attend our basic course "CMC Management in Regulatory Affairs"
- Afterwards you select and participate in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
- You will receive structured further training and comprehensive knowledge on topics relating to CMC management
- You can specialise according to your main field of interest through the targeted selection of seminars
Please visit our webpage Website
In-house seminars: Advanced training tailor-made!
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.
Benefits of a FORUM Institut training course
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.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
Technical requirements
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.
Access to and procedure for online events
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.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de