2026-03-11 2026-03-11 , online online, 1,690 € zzgl. MwSt. Dr. Federico Marighetti https://forum-institut.de/seminar/26092452-apis-in-the-dossier-quality-data-e-submission-global-regulatory-strategy/referenten/26/26_09/26092452-seminar-pharma-apis-in-the-dossier,-global-regulatory-strategy_marighetti-federico.jpg APIs in the dossier: Quality data, e-submission, global regulatory strategy

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.

Topics
  • 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.
Aims and objectives
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.

Seminar pharma - APIs in the dossier - (global) regulatory strategy

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.

Benefits
  • 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

Webcode 26092452

Jetzt buchen

JETZT Buchen
Referenten

Dr. Federico Marighetti

- requested - Bonn , GERMANY

Expert for Pharmaceutical Quality

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.

Dr. Henrietta Dehmlow

F. Hoffmann La Roche AG, Basel, SWITZERLAND

Head of Submission Management Small Molecules Basel

Dr. Lisa Matzen

Boehringer Ingelheim International GmbH, Ingelheim, GERMANY

Head of Global CMC Regulatory Affairs

Alles auf einen Blick

Termin

29 - 30/09/2026

29 - 30/09/2026

Zeitraum

Day 1: 09:00 until 05:00 pm CET
Day 2: 09:00 until 12:00 pm CET
You may dial in 30 minutes before the lecture starts

Day 1: 09:00 until 05:00 pm CET
Day 2: 09:00 until 12:00 pm CET
You may dial in 30 minutes before the lecture starts
Veranstaltungsort

online

online

Downloads
Qualification course: CMC-Specialist in Regulatory Affairs
Qualification course: CMC-Specialist in Regulatory Affairs
Gebühr

Event - 1,690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.

Event - 1,690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

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.

Topics

  • 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.

Aims and objectives

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.

Detailed programme

Day 1: 09:00 until 05:00 pm CET
Day 2: 09:00 until 12:00 pm CET
You may dial in 30 minutes before the lecture starts

Dr Helmut Vigenschow

Overview and scope of ICH guidelines
  • 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

Development of API manufacturing processes
  • 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
Additional flexible breaks can be arranged with the speakers.

Dr Federico Marighetti and Dr Helmut Vigenschow

Impurities
  • 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
Additional flexible breaks can be arranged with the speakers.

Dr Helmut Vigenschow

EMA Guideline on the chemistry of active substances
  • Key aspects in the draft revision

Dr Helmut Vigenschow

API specification and stability
  • GMP-related specification
  • API specification in the CTD
  • Stability data and retest date
  • Changes initiated by the new ICH Q1 stability guideline

Biobreak
Additional flexible breaks can be arranged with the speakers.

Dr Federico Marighetti and Dr Helmut Vigenschow

Current structure of CTD module 3.2.S, changes according to the draft guideline ICH M4Q(R2)
  • 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

ASMF and CEP
  • 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


Dr Henrietta Dehmlow

e-submission requirements to active ingredients
  • eCTD for APIs
  • eCTD for CEP submission at EDQM
  • Electronic submissions of DMF and ASMF

Biobreak
Additional flexible breaks can be arranged with the speakers.

Dr Lisa Matzen

Global approval relevant API changes: Challenges and opportunities
  • Typical changes, e.g., API manufacturers, synthesis, analytical methods and regulatory consequences
  • Dossier up-date, DMF, ASMF and CEP
  • Global regulatory strategy and country-specific requirements outside the EU/US
  • Case studies including questions from authorities
  • New regulatory trends, e.g., ICH Q12, reliance and AI

End of seminar


More information

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

Please visit our Website

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.

This distinguishes our events

of 5 stars of all ratings from 2025

of 5 stars on Trustpilot = good

Recommendations

Änderungsgesuche

Holen Sie sich Ihr Update in Sachen Schweiz-nationale Änderungsgesuche und europäische Variations gemäss EU Regulation 2...

22.04.2026 in
Details

Dossierbewertung bei Lizenzierung, Zulassungs- und Produktkauf

Dieses Seminar vermittelt umfassendes Wissen zur Dossierbewertung bei Lizenzierungen, Zulassungs- und Produktkäufen, von...

11.03.2026 in
Details

Informationsbeauftragte in internationalen Unternehmen

Arzneimittelkommunikation - Globale Märkte, nationale Gesetze?

11.03.2026 in
Details

All about ATMP

The online training with details on development, quality, CMC, approval and market access (including an update on the up...

23. - 24.03.2026 in
Details

Pharmazeutische Entwicklung

Pharmazeutische Entwicklung - Von der Idee bis zur Zulassung und Marktreife im GMP-Umfeld. Regulatorische Anforderungen ...

17.03.2026 in
Details

Go forward

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...

Details
Whitepaper: Stability Testing of Drug Products - Focus: EU and ICH Requirements
Qualification course: CMC-Specialist in Regulatory Affairs

The modular training courses offered by the FORUM Institute for Management: Top seminars Flexible selection Cost sa...

Details
Qualification course: CMC-Specialist in Regulatory Affairs
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.

Details
Our rating in 2025