APIs in the dossier: Quality data, e-submission, global regulatory strategy
Includes updates on (Draft) ICH Q1, ICH M4Q(R2)), ICH Q12, Reliance, AI, etc
- Update: (Draft) ICH Q1, ICH M4Q(R2) und ASMF procedure
- Global RA: Brazil, Russia, China, Japan
- Regulatory trends: ICH Q12, Reliance, KI
- Officially certified: ISO 9001 + 21001
Online-Seminar
Ab
1.690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Buchungsdetails
Online-Seminar
Ab
1.690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the right seminar for you! Includes updates on (Draft) ICH Q1, (Draft) ICH M4Q(R2), and ASMF topics, as well as information on new regulatory trends such as ICH Q12, reliance, and AI.
Your speakers
What to Expect
- Overview and scope of ICH guidelines
- Manufacturing processes, impurities, specifications and stability
- Structure of CTD module 3.2.S, changes according to ICH M4Q(R2)
- ASMF and CEP procedures
- e-submission requirements to active ingredients
- Global approval relevant API changes: Challenges & opportunities
Who Should Attend
This seminar is designed for specialists and managers in Regulatory Affairs, CMC, R&D, and GMP-Quality who are responsible for integrating API quality data into marketing authorisation dossiers or managing API-related submissions and lifecycle activities.
The focus is on small molecules and current EU regulatory requirements.
Objective of the Event
The regulatory environment for active pharmaceutical ingredients (APIs) is changing rapidly.
Keeping pace requires more than just knowing the guidelines.
This seminar provides comprehensive, practice-oriented training on current and upcoming CMC documentation standards, including the revised CTD structure under ICH M4Q(R2), impurity control requirements, ASMF, CEP, as well as practical guidance on eCTD submissions and global post-approval change management. Real-world cases and expert insights support the understanding of the specific daily challenges to be mastered.
Attendees will leave with a solid understanding of EU/ICH requirements, global regulatory strategies, and emerging trends.
Your Benefit
Four experts with longtime and diverse experience will give you valuable tips, highlight critical aspects, and point out what is ultimately relevant for your CMC dossier. The focus will be on EU and US requirements, but non-EU specifics in the change control process will also be discussed. Benefit from the digression on regulatory trends, including ICH Q12, reliability, and AI.
Programme
Day 1: 09:00 until 05:00 pm CET
Day 2: 09:00 until 12:00 pm CET
Day 1
Dr Helmut Vigenschow
- ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
- ICH Q11 Development and manufacture of drug substances
- Concept paper on the revision of the EU GMP Annex 15
Dr Federico Marighetti and Dr Helmut Vigenschow
- Synthesis procedure description for GMP and CTD
- Definition of starting materials and intermediates
- Solvents
- Risk assessment of synthesis procedures
- Primary packaging
- Dealing with multiple API manufacturers in CMC
Additional flexible breaks can be arranged with the speakers.
Dr Federico Marighetti and Dr Helmut Vigenschow
- Impurities from synthesis and degradation
- Safety impact of impurities
- Elemental impurities
- Genotoxic impurities, including ICH M7 guideline
- Establishment of purge factors
- N-nitrosamines risk assessment update
- EMA reflection paper on the qualification of non-mutagenic impurities
Additional flexible breaks can be arranged with the speakers.
Dr Helmut Vigenschow
- Key aspects in the draft revision
Dr Helmut Vigenschow
- GMP-related specification
- API specification in the CTD
- Stability data and retest date
- Changes initiated by the new ICH Q1 stability guideline
Additional flexible breaks can be arranged with the speakers.
Dr Federico Marighetti and Dr Helmut Vigenschow
- 3.2.S Overview
- Other CTD sections related to APIs
- Overview on fundamental changes in the CTD structure for quality data
- What will be the structure for quality data related to APIs?
Dr Federico Marighetti
- Content and processes related to ASMF
- Proposed changes with the new draft EU directive
- Working with the CEP
- CEP 2.0
- Who is responsible for what?
- Questions and answers (Q&A): how to use a CEP in the context of a MAA or MAV
- Procedural differences to the US FDA DMF Type II
Overview and scope of ICH guidelines
Overview and scope of ICH guidelines
Dr Helmut Vigenschow
- ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
- ICH Q11 Development and manufacture of drug substances
- Concept paper on the revision of the EU GMP Annex 15
Development of API manufacturing processes
Development of API manufacturing processes
Dr Federico Marighetti and Dr Helmut Vigenschow
- Synthesis procedure description for GMP and CTD
- Definition of starting materials and intermediates
- Solvents
- Risk assessment of synthesis procedures
- Primary packaging
- Dealing with multiple API manufacturers in CMC
Biobreak
Biobreak
Additional flexible breaks can be arranged with the speakers.
Impurities
Impurities
Dr Federico Marighetti and Dr Helmut Vigenschow
- Impurities from synthesis and degradation
- Safety impact of impurities
- Elemental impurities
- Genotoxic impurities, including ICH M7 guideline
- Establishment of purge factors
- N-nitrosamines risk assessment update
- EMA reflection paper on the qualification of non-mutagenic impurities
Lunch break
Lunch break
Additional flexible breaks can be arranged with the speakers.
EMA Guideline on the chemistry of active substances
EMA Guideline on the chemistry of active substances
Dr Helmut Vigenschow
- Key aspects in the draft revision
API specification and stability
API specification and stability
Dr Helmut Vigenschow
- GMP-related specification
- API specification in the CTD
- Stability data and retest date
- Changes initiated by the new ICH Q1 stability guideline
Biobreak
Biobreak
Additional flexible breaks can be arranged with the speakers.
Current structure of CTD module 3.2.S, changes according to the draft guideline ICH M4Q(R2)
Current structure of CTD module 3.2.S, changes according to the draft guideline ICH M4Q(R2)
Dr Federico Marighetti and Dr Helmut Vigenschow
- 3.2.S Overview
- Other CTD sections related to APIs
- Overview on fundamental changes in the CTD structure for quality data
- What will be the structure for quality data related to APIs?
ASMF and CEP
ASMF and CEP
Dr Federico Marighetti
- Content and processes related to ASMF
- Proposed changes with the new draft EU directive
- Working with the CEP
- CEP 2.0
- Who is responsible for what?
- Questions and answers (Q&A): how to use a CEP in the context of a MAA or MAV
- Procedural differences to the US FDA DMF Type II
Recap and outstanding questions
End of seminar day I
Day 2
Dr Henrietta Dehmlow
- eCTD for APIs
- eCTD for CEP submission at EDQM
- Electronic submissions of DMF and ASMF
Additional flexible breaks can be arranged with the speakers.
Dr Lisa Matzen
- Typical regulatory relevant changes, e.g., API manufacturers, synthesis, analytical methods and regulatory consequences
- Global regulatory strategy and country-specific requirements
- Case studies including questions from authorities
- New regulatory trends, e.g., ICH Q12, reliance and AI
e-submission requirements to active ingredients
e-submission requirements to active ingredients
Dr Henrietta Dehmlow
- eCTD for APIs
- eCTD for CEP submission at EDQM
- Electronic submissions of DMF and ASMF
Biobreak
Biobreak
Additional flexible breaks can be arranged with the speakers.
Global approval relevant API changes: Challenges and opportunities
Global approval relevant API changes: Challenges and opportunities
Dr Lisa Matzen
- Typical regulatory relevant changes, e.g., API manufacturers, synthesis, analytical methods and regulatory consequences
- Global regulatory strategy and country-specific requirements
- Case studies including questions from authorities
- New regulatory trends, e.g., ICH Q12, reliance and AI
End of seminar
Downloads
brochure
All details and content at a glance.
Qualification course: CMC-Specialist in Regulatory Affairs
Qualification course: CMC-Specialist in Regulatory Affairs
HerunterladenWeitere Informationen
Qualification course - CMC Specialist in Regulatory Affairs
This seminar can be taken as an elective module as part of our CMC Specialist in Regulatory Affairs qualification course.
The course concept:
- You attend our basic course - The CMC Manager in Regulatory Affairs
- You will then take part in 3 additional seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
- You will receive structured training and comprehensive knowledge in CMC Regulatory Affairs
- You can specialize by selecting seminars that are tailored to your area of expertise
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Further Information
Your Contact Person
We are happy to advise you personally and individually.

Dr. Birgit Wessels
Konferenzmanagerin Pharma & Healthcare
+49 6221 500-652
b.wessels@forum-institut.de






