2025-04-03 2025-04-03 , online online, 1,690 € zzgl. MwSt. Dr. Cornelia Nopitsch-Mai https://www.forum-institut.de/seminar/25092450-apis-in-regulatory-affairs/referenten/25/25_09/25092450-seminar-pharma-apis-in-regulatory-affairs-cmc-know-how_nopitsch-mai-cornelia.jpg APIs in Regulatory Affairs

Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!

Topics
  • API and starting material: quality data for module 3, ASMF, CEP and US-DMF
  • Starting material: regulatory "hurdles", assessing suitability
  • Strategic CMC writing: which data is relevant for dossiers?
  • eSubmission requirements for active pharmaceutical ingredients
  • Global approval-relevant API changes: challenges & opportunities


Who should attend
This event is aimed at specialists and managers in the pharmaceutical industry who want to

  • Integrate quality data on APIs into the marketing authorization dossier
  • Submit marketing authorization applications under submission of an ASMF, CEP or US-DMF

and in particular work in the Regulatory Affairs, CMC Writing, Development, Analytics and Quality departments.

The focus is on small molecules, requirements for biotechnologically manufactured active substances are not addressed.
Aims and objectives
After the seminar, you will know the requirements for the presentation of quality data of active pharmaceutical ingredients (APIs) in the dossier in Europe and the USA. You will also be familiar with the presentation in the ASMF, CEP and US-DMF.

You will be able to assess the suitability of an API Starting Material and draw conclusions from common misinterpretations in case studies. You will also be able to put the regulatory requirements for the impurity profile into practice.

You will have received strategic tips for your CMC writing and will be able to distinguish between GMP-relevant and dossier-relevant data. You plan your Scientific Advice Meetings sensibly and purposefully.

You will have learned what to consider when submitting change notifications for active substances and know what to look out for in the country-specific mandatory eSubmission.
Your benefit

Based on their diverse know-how, our four experienced experts will give you valuable tips, highlight critical aspects and point out what is ultimately relevant for your CMC dossier. The focus is on the EU and US requirements, but the non-EU special features in the change control procedure are also discussed.

Seminar pharma - APIs in Regulatory Affairs - CMC know-how

APIs in Regulatory Affairs

- Online-training -

Benefits
  • EU and US requirements
  • Multiple perspectives: industry, authorities, consulting
  • Exchange with industry colleagues: how do others do it?
  • Officially certified according to ISO 9001 + 21001

Webcode 25092450

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

22-23/09/2025

22-23/09/2025

Zeitraum

Day 1: 09:00 am till 05:00 pm
Day 2: 09:00 am till 12:00 pm
You may dial-in 30 minutes before the session starts

Day 1: 09:00 am till 05:00 pm
Day 2: 09:00 am till 12:00 pm
You may dial-in 30 minutes before the session starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!

Topics

  • API and starting material: quality data for module 3, ASMF, CEP and US-DMF
  • Starting material: regulatory "hurdles", assessing suitability
  • Strategic CMC writing: which data is relevant for dossiers?
  • eSubmission requirements for active pharmaceutical ingredients
  • Global approval-relevant API changes: challenges & opportunities


Who should attend
This event is aimed at specialists and managers in the pharmaceutical industry who want to

  • Integrate quality data on APIs into the marketing authorization dossier
  • Submit marketing authorization applications under submission of an ASMF, CEP or US-DMF

and in particular work in the Regulatory Affairs, CMC Writing, Development, Analytics and Quality departments.

The focus is on small molecules, requirements for biotechnologically manufactured active substances are not addressed.

Aims and objectives

After the seminar, you will know the requirements for the presentation of quality data of active pharmaceutical ingredients (APIs) in the dossier in Europe and the USA. You will also be familiar with the presentation in the ASMF, CEP and US-DMF.

You will be able to assess the suitability of an API Starting Material and draw conclusions from common misinterpretations in case studies. You will also be able to put the regulatory requirements for the impurity profile into practice.

You will have received strategic tips for your CMC writing and will be able to distinguish between GMP-relevant and dossier-relevant data. You plan your Scientific Advice Meetings sensibly and purposefully.

You will have learned what to consider when submitting change notifications for active substances and know what to look out for in the country-specific mandatory eSubmission.

Your benefit

Based on their diverse know-how, our four experienced experts will give you valuable tips, highlight critical aspects and point out what is ultimately relevant for your CMC dossier. The focus is on the EU and US requirements, but the non-EU special features in the change control procedure are also discussed.

Detailed programme

Day 1: 09:00 am till 05:00 pm
Day 2: 09:00 am till 12:00 pm
You may dial-in 30 minutes before the session starts

Welcome, introductions and expectations

Dr Cornelia Nopitsch-Mai

Starting materials: Regulatory requirements
  • Guideline on Chemistry of active Substances, ICH Q11, ICH Q11 Q&A
  • Evaluation of the suitability of the starting material and its specification
  • Risk assessment according to ICH Q8-10
  • Common misinterpretations and difficulties, practical examples

Biobreak


Dr Helmut Vigenschow

Requirements for CMC data with APIs
  • Specification and analytical methodsRegulatory aspects (ICH, Pharmacopoeia)Determining specifications (IMPD/CTD)Critical issues, case studies
  • ImpuritiesEvaluation of impurities
    • Residual solvents
    • Risk assessment/justificationPractical approach in the dossier
  • Draft Revision of the guideline on Chemistry of active Substances
  • Stability

Lunch break


Dr Helmut Vigenschow

Strategical CMC Writing: Scientific Data vs. CMC Data
  • What data must be included in the module?
  • What is relevant to GMP/dossiers?
  • Timelines and strategic planning
  • Authority meetings: when and which?
  • Case studies

Dr Cornelia Nopitsch-Mai

Risk assessment of synthesis
  • Introduction into risk assessment
  • Risk Assessment: metals (ICH Q3D), mutagenic impurities (ICH M7)
  • Unexpected impurities including nitrosamines

Biobreak


Dr Helmut Vigenschow

Possible procedures for APIs: ASMF, CEP and US-DMF
  • Key aspects (contract manufacturer/authorisation holder)
  • Procedure, advantages and disadvantages
  • Differences between EU and US
  • Implementation into module 3
  • Dealing successfully with hurdles

Recap and outstanding questions


End of seminar day 1


Dr Henrietta Dehmlow

eSubmission requirements for APIs
  • eCTD for APIs
  • eCTD for CEP submission at EDQM
  • Electronic submissions of DMF and ASMF

Biobreak


Dr Lisa Matzen

Global approval-relevant API changes: challenges & opportunities
  • Typical changes, e.g. API manufacturers, synthesis, analytical methods and regulatory consequences
  • Dossier up-date, DMF, ASMF and CEP
  • Special features outside the EU/US, e.g. Brazil, Russia, China, Japan
  • Practical case studies incl. questions from authorities

End of the seminar


Zusatzinformationen

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 then take part in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
- You will receive structured further training and comprehensive knowledge in CMC Regulatory Affairs - You can specialize through the targeted selection of seminars according to your main area of activity

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