CMC for Biologicals
With a focus on proteins
- Including an outlook on the new (Draft) ICH Q1, ICH M4Q(R2)
- In-depth know-how from different perspectives
- Considerations for the implementation of QbD
- Certified according to ISO 9001 + 21001
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 PreMeeting.
Period:
9:00 am - 5:30 pm CET - Online training
You may dial in 30 minutes in advance
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 PreMeeting.
Period:
9:00 am - 5:30 pm CET - Online training
You may dial in 30 minutes in advance
Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).
Your speakers
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI),
Langen
Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for…
Your speaker
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI),
Langen
Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for marketing authorisation applications, scientific advices and clinical trial applications.
Dr. Michael Jandke
Independent consultant
Since August 2024, Dr Jandke has been serving as an independent consultant.
Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs…
Your speaker
Dr. Michael Jandke
Independent consultant
Since August 2024, Dr Jandke has been serving as an independent consultant.
Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs across the European Union. Before his tenure at Miltenyi Biomedicine, Michael held various leadership roles within innovative healthcare companies, focusing on areas such as somatic cell-based medicinal products (sCBMP), tissue-engineered products (TEP), and gene therapeutics, as well as in the generic pharmaceutical sector.
Dr Jandke studied Pharmacy at Humboldt University in Berlin and earned a Doctorate in Molecular Medicine from the same institution.
Dr. René Thürmer
Expert for Pharmaceutical Quality, Bonn, GERMANY
Dr. René Thürmer studied chemistry at the University of Tübingen, where he obtained his doctorate in 1999. He has been working in a public institution…
Your speaker
Dr. René Thürmer
Expert for Pharmaceutical Quality, Bonn, GERMANY
Dr. René Thürmer studied chemistry at the University of Tübingen, where he obtained his doctorate in 1999. He has been working in a public institution since 2000. He is currently Deputy Head of the Department of Pharmaceutical Biotechnology, Inspection and Quality. He is the author and co-author of numerous articles in the fields of peptide, carbohydrate and natural product chemistry as well as mass spectrometry.
What to Expect
- Regulatory framework: ICH guidelines (including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2))
- Essential data for biologics for Module 3
- Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins
- Comparability requirements for changes
- Critical data: Which data must be included in the dossier, which not?
Who Should Attend
This online training is aimed at specialists and managers in the biopharmaceutical industry who are responsible for creating and maintaining the quality module in the CTD or who make a significant contribution to this.
Especially addressed are the departments of regulatory affairs, medical science, quality assurance and quality control.
Objective of the Event
The requirements for Module 3 of the CTD differ fundamentally for biotech products from those for non-biologics.
During this online training, you will gain knowledge with regard to CMC management specifically for biologicals.
After participating in the seminar, you will be familiar with the ICH guidelines, which form the regulatory framework (including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2)). You will know which data are required for Module 3 and which significant differences exist to non-biologics. You will know the specifics of the documentation for antibodies, immunoglobulins and recombinant proteins and have been provided with practical solutions. Our experts will discuss the comparability requirements in the event of a change by means of a case study.
Finally, you will work out in the workshop which data is mapped in the dossier and how, and learn how to skilfully avoid common mistakes.
Your Benefit
- The references to regulatory requirements/guidelines, the overview of required studies that are reviewed by the authorities prior to market authorisation" were extremely helpful for participants last year.
- "A very good overview of the relevant topics" is how one person would characterise the event to their colleagues.
Programme
9:00 am - 5:30 pm CET - Online training
09:00
Dr Michael Jandke
- Overview of the regulatory requirements
- Which institutions are involved in the approval process?
- Biologics vs. non-biologics: Elementary differences
- What data are required for Module 3? Among others for:
- Manufacture, characterisation
- Reference standards, stability
- Excipients
- ATMPs: The specifics
10:30
10:45
Dr Steffen Groß
- Process validation
- Regulatory requirements (including outlook on the new (Draft) ICH M4Q(R2))
- Process evaluation and verification
- Continuous vs. traditional approach
- Characterisation
- Potency
- Contaminants
- Container Closure Systems
- Stability (including outlook on the new (Draft) ICH Q1)
- Implementation "Quality by Design"
- FMEA tools
- RTRT (Real Time Release Testing)
12:15
Dr Steffen Groß
- Requirements through the Variation Regulation
- Case study
13:00
14:00
Dr René Thürmer
- Analytics, validation of analytical methods
- Case studies
15:15
15:30
Dr Michael Jandke
- Common shortcomings in dossier evaluation:Which data must be in the dossier, which not?
- CMC relevant essentials on the procedural steps of the submission
- Planning resources within the company
- Back-up data for Module 3 for the clock stop phase
17:15
17:30
09:00
Quality dossier biotech medicines: The regulatory framework
Quality dossier biotech medicines: The regulatory framework
Dr Michael Jandke
- Overview of the regulatory requirements
- Which institutions are involved in the approval process?
- Biologics vs. non-biologics: Elementary differences
- What data are required for Module 3? Among others for:
- Manufacture, characterisation
- Reference standards, stability
- Excipients
- ATMPs: The specifics
Bio break
10:45
Challenges in Module 3: Focus on antibodies and immunoglobulins
Challenges in Module 3: Focus on antibodies and immunoglobulins
Dr Steffen Groß
- Process validation
- Regulatory requirements (including outlook on the new (Draft) ICH M4Q(R2))
- Process evaluation and verification
- Continuous vs. traditional approach
- Characterisation
- Potency
- Contaminants
- Container Closure Systems
- Stability (including outlook on the new (Draft) ICH Q1)
- Implementation "Quality by Design"
- FMEA tools
- RTRT (Real Time Release Testing)
12:15
Comparability requirements for changes
Comparability requirements for changes
Dr Steffen Groß
- Requirements through the Variation Regulation
- Case study
Lunch break
14:00
Challenges in Module 3: Focus on recombinant proteins
Challenges in Module 3: Focus on recombinant proteins
Dr René Thürmer
- Analytics, validation of analytical methods
- Case studies
Bio break
15:30
CMC Writing, submission strategy and resource planning
CMC Writing, submission strategy and resource planning
Dr Michael Jandke
- Common shortcomings in dossier evaluation:Which data must be in the dossier, which not?
- CMC relevant essentials on the procedural steps of the submission
- Planning resources within the company
- Back-up data for Module 3 for the clock stop phase
Q&As and outstanding questions
End of online training
Downloads
Request the documents using our form.
Abbreviations-Drug-Regulatory-Affairs-and-CMC
Further Informations
Modular qualification course to become "Development Experts Biologics"
This seminar is elective module of our qualification course to become a "Development Experts Biologics.
The program structure:
- You will attend our basic course "Biopharmaceuticals" (day I+II; day III is an elective module)
- Afterward, you'll participate in 3 additional elective seminar modules (= 3 seminar days), which you'll select individually from the program curriculum
- You'll receive structured professional development and comprehensive knowledge on topics related to the development and manufacture of biologics
- You can specialise by selecting seminars tailored to your specific area of focus
For more information (in German language) please feel free to visit our 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
Free pre-meeting and technology check
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.
Customer Testimonials
What satisfied participants say
Our Recommendations
Further Information
Qualification course CMC-Specialist in Regulatory Affairs
Our modular qualification courses top seminars, felxible selection and cost savings.
Whitepaper: Stability Testing of Drug Products - Focus: EU and ICH Requirements
Stay ahead of proposed regulatory changes in pharmaceutical stability testing. This "practical guide" helps you navigate…
Our rating in 2025
More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.
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