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

Buchungsdetails

Online-Seminar

Ab 1.690,00 € zzgl. MwSt.
Leistungen & Ablauf

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

Dr. Federico Marighetti

Dr. Federico Marighetti

- requested -
Bonn , GERMANY

Expert for Pharmaceutical Quality
Dr. Federico Marighetti is a pharmaceutical regulatory professional with extensive experience in the quality assessment of active substances…

Dr. Helmut Vigenschow

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,…

Dr. Henrietta Dehmlow

Dr. Henrietta Dehmlow

F. Hoffmann La Roche AG,
Basel, SWITZERLAND

Head of Submission Management Small Molecules Basel

Dr. Lisa Matzen

Dr. Lisa Matzen

Boehringer Ingelheim International GmbH,
Ingelheim, GERMANY

Head of Global CMC Regulatory Affairs

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

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
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

Additional flexible breaks can be arranged with the speakers.

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

Additional flexible breaks can be arranged with the speakers.

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

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

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)
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
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

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

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

Additional flexible breaks can be arranged with the speakers.

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

Additional flexible breaks can be arranged with the speakers.

EMA Guideline on the chemistry of active substances

Dr Helmut Vigenschow

  • Key aspects in the draft revision

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

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)

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

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

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

Additional flexible breaks can be arranged with the speakers.

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

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

Additional flexible breaks can be arranged with the speakers.

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

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Qualification course: CMC-Specialist in Regulatory Affairs

Weitere 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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