Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
CMC compliance: What to do now and what ICH Q3E will bring
- E&L: Regulatory expectations as currently in place to ICH Q3E
- Global regualtory strategy: Harmonisation with USP chapters + BPOG
- First-hand information
- Officially certified: ISO 9001 + 21001
Seminar
Ab
690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 9:00 am until 1:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
Buchungsdetails
Seminar
Ab
690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 9:00 am until 1:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.
Your speakers
Dr. Katrin Buss
Expert pharmaceutical quality and regulatory affairs, Bonn, GERMANY
Your speaker
Dr. Katrin Buss
Expert pharmaceutical quality and regulatory affairs, Bonn, GERMANY
Samo Kuzmič
Lek d.d. (Sandoz),
Ljubljana, SLOVENIA
Project Manager | Global Development Center of Excellence for Extractables & Leachables Lead
Samo Kuzmic is a Project Manager, currently (since 2025) serving as…
Your speaker
Samo Kuzmič
Lek d.d. (Sandoz),
Ljubljana, SLOVENIA
Project Manager | Global Development Center of Excellence for Extractables & Leachables Lead
Samo Kuzmic is a Project Manager, currently (since 2025) serving as Global Center of Excellence Lead for Extractables & Leachables (E&L) at Lek, a Sandoz company.
He has been with the Sandoz group for over seven years, progressing through scientific roles in analytical development and mutagenic impurity assessment, building deep expertise in analytical chemistry, regulatory compliance, and pharmaceutical product safety.
What to Expect
- Regulatory expectations and CMC requirements (as currently in place to ICH Q3E)
- Industry strategies for current global E&L requirements
- ICH Q3E under development: Scope and key principles from an authority perspective
- From draft to operations: How industry can prepare for ICH Q3E
Who Should Attend
This seminar is designed for experienced professionals in Regulatory Affairs and CMC who are responsible for regulatory submissions, dossier preparation, and quality documentation.
Professionals that need to navigate today's E&L regulatory landscape while anticipating tomorrow's guideline(s) will particularly benefit from participating.
Objective of the Event
This seminar provides you with a comprehensive overview of the draft regulatory framework of the ICH Q3E, specific CMC requirements, and practical implementation strategies based on both authority and industry perspectives.
The seminar covers the regulatory framework and CMC-specific requirements outlined in the draft guideline, including study design, safety assessments, and Module 3 documentation.
Beyond that, the seminar will also explore how ICH Q3E integrates with the existing E&L guidance documents, such as the USP E&L chapters and BPOG, providing a clear understanding of how these standards work together to support a robust global regulatory strategy.
After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.
Your Benefit
After having participated in the course, you are equipped to
- master current and future CMC-specific E&L requirements
,
- avoid deficiencies - authority and industry view, and
- implement a global regulatory strategy.
Programme
from 9:00 am until 1:00 pm CET
Dr Katrin Buss
- E&L studies: When and what is required?
- Analytical methods and validation requirements
- Documentation requirements for regulatory submissions (CTD Module 3)
- Assessment perspective: What regulators look for in submissions
- Common deficiencies and how to avoid them
Samo Kuzmic
- Global E&L landscape: Navigating requirements and expectations across major regulatory markets
- Designing robust E&L studies: Practical testing strategies that meet regulatory and technical needs
- Material selection, qualification, and supplier management (CMC perspective)
- Cross-functional workflows: Coordinating RA, CMC, analytical, and toxicology teams
Dr Katrin Buss
- Scope of application
- Risk-based approach and quality risk management principles
- Integration with existing ICH guidelines (Q3A-D, Q6A, M7)
- Timelines and transition considerations
- Further perspectives and ongoing developments
Samo Kuzmic
- End-to-end workflow for manufacturing components
- Packaging and delivery components/systems workflow
- Safety assessment workflow
- Lifecycle management
- Global harmonisation in practice: How ICH Q3E integrates with existing E&L frameworks, including USP 1663>, 1664>, 1665>, 665>, and BPOG
- Lessons learned and next steps for implementation
Welcome, introduction, expectations
Regulatory expectations and CMC requirements (as currently in place to ICH Q3E)
Regulatory expectations and CMC requirements (as currently in place to ICH Q3E)
Dr Katrin Buss
- E&L studies: When and what is required?
- Analytical methods and validation requirements
- Documentation requirements for regulatory submissions (CTD Module 3)
- Assessment perspective: What regulators look for in submissions
- Common deficiencies and how to avoid them
Biobreak
Industry strategies for current E&L requirements
Industry strategies for current E&L requirements
Samo Kuzmic
- Global E&L landscape: Navigating requirements and expectations across major regulatory markets
- Designing robust E&L studies: Practical testing strategies that meet regulatory and technical needs
- Material selection, qualification, and supplier management (CMC perspective)
- Cross-functional workflows: Coordinating RA, CMC, analytical, and toxicology teams
ICH Q3E under development: Scope and key principles from an authority perspective
ICH Q3E under development: Scope and key principles from an authority perspective
Dr Katrin Buss
- Scope of application
- Risk-based approach and quality risk management principles
- Integration with existing ICH guidelines (Q3A-D, Q6A, M7)
- Timelines and transition considerations
- Further perspectives and ongoing developments
Biobreak
From draft to operations: How industry can prepare for ICH Q3E
From draft to operations: How industry can prepare for ICH Q3E
Samo Kuzmic
- End-to-end workflow for manufacturing components
- Packaging and delivery components/systems workflow
- Safety assessment workflow
- Lifecycle management
- Global harmonisation in practice: How ICH Q3E integrates with existing E&L frameworks, including USP 1663>, 1664>, 1665>, 665>, and BPOG
- Lessons learned and next steps for implementation
Recap and Q&As
End of seminar
Downloads
Request the documents using our form.
Brochure
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Qualification course - CMC Specialist in Regulatory Affairs
This seminar can be taken as elective module as part of our qualification course program to become a CMC Specialist.
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