Combination products: From CMC and quality data to a submission-ready regulatory dossier
Practical preparation of compliant, sound documentation for drug-device combination products
- EU regulatory framework "demystified"
- CMC & quality data mastered
- Submission-ready dossier strategies
- Real-world case studies included
- Officially certified according to ISO 9001 and 21001
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am to 5:00 pm CET - online training
You may dial in 30 minutes before the lecture starts
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am to 5:00 pm CET - online training
You may dial in 30 minutes before the lecture starts
The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing authorisation and conformity assessment, equipping you with practical strategies for building compliant, submission-ready dossiers.
Your speakers
Dr. Matthias Kühnle
Freelance Health Care Consulting,
Hochdorf, GERMANY
Consultant, Owner Retail Pharmacies
After completing his studies in pharmacy, Dr Kühnle held various positions in the CMC and RA departments at Teva…
Your speaker
Dr. Matthias Kühnle
Freelance Health Care Consulting,
Hochdorf, GERMANY
Consultant, Owner Retail Pharmacies
After completing his studies in pharmacy, Dr Kühnle held various positions in the CMC and RA departments at Teva ratiopharm. His main areas of focus included the creation and consolidation of modules 2.3 and 3, as well as the coordination of interface issues between R&D, QA, CMC, and RA. This was followed by positions as team leader for Non-EU Regulatory Affairs and deputy head of the Regulatory Affairs department at Wörwag Pharma GmbH & Co. KG. Since 2017, Dr Kühnle has been working as an independent consultant specializing in global drug regulatory affairs, CMC, and interface issues between RA-QA and the pharmaceutical industry point of sale (pharmacies). He has also been the owner and manager of the Kirch Pharmacy in Hochdorf since 2017, and in 2020 and 2023 he took over the Eberhard Pharmacy in Notzingen and the Alb Pharmacy in Schlierbach as the new owner.
Dr. Jan Zaloga
Zaloga Consulting,
Ehningen, GERMANY
Contract Auditor, Principal Quality Advisor
Dr Jan Zaloga works as an auditor and independent consultant specialising in quality management, GMP and regulatory…
Your speaker
Dr. Jan Zaloga
Zaloga Consulting,
Ehningen, GERMANY
Contract Auditor, Principal Quality Advisor
Dr Jan Zaloga works as an auditor and independent consultant specialising in quality management, GMP and regulatory matters within the pharmaceutical and medical technology sectors. He has over ten years’ professional experience in senior roles at both large corporations and SMEs, as well as advising international clients. His work focuses on the interface between medicines and medical devices, encompassing the establishment and further development of quality management systems, ensuring regulatory compliance, audits and preparation for inspections, as well as the implementation of regulatory requirements within complex organisations. Thanks to his strong background in operational business and experience gained from numerous audits, he combines regulatory expertise with a deep understanding of operational processes. As a pharmacist with a PhD, he explains complex regulatory topics in a practical, solution-oriented manner, with a focus on the demands of day-to-day work.
What to Expect
- Key guidelines and requirements (Focus: EU)
- Marketing authorisation process for medicinal products
- Conformity assessment of medical devices
- Documentation strategy using quality related data as an example
- Regulatory strategy and common pitfalls/solutions
- Case studies/practical workshop
Who Should Attend
This seminar is designed for regulatory affairs and quality professionals working in the pharmaceutical, medical device, or combination product industry, particularly those involved in marketing authorisation, conformity assessment, or CMC documentation.
It is equally valuable for product managers, project leads, and legal/compliance specialists who need a solid understanding of the regulatory frameworks governing drug-device combination products in the EU and beyond.
Objective of the Event
Drug-device combination products sit at the intersection of two highly complex regulatory worlds. Knowing how to navigate and combine the very different regulatory requirements for medicinal products and medical devices is becoming increasingly critical.
In this seminar, you will gain a practice-oriented understanding of the EU regulatory landscape, from key guidelines and marketing authorisation to conformity assessment and documentation strategy.
Through real-world case studies, you will learn how to structure compliant, submission-ready dossiers and confidently manage common pitfalls in your day-to-day work.
Your Benefit
After having participated, you will be equipped with
- a thorough understanding of the EU regulatory framework for drug-device combination products, including MDR, EU GMP, and relevant ICH guidelines.
- the ability to determine the primary mode of action (PMOA) and select the appropriate regulatory pathway for your product.
- practical strategies for structuring compliant, submission-ready dossiers - and avoiding the most common pitfalls in your day-to-day work.
Programme
from 9:00 am to 5:00 pm CET
- Medicinal products: EU GMP Volume 4, Annexes, selected ICH guidelines and more
- Medical devices: MDR/IVDR and annexes, ISO 13485/ISO 14971, roles and responsibilities, CE marking/EU Declaration of Conformity/UDI
- Combination products: MDR Article 1 and Article 117, Annex IX, borderline classification rules (Article 2 of Directive 2001/83/EC), EMA 259165/2019, EMA 37991/2019, outlook on FDA (unified approach), COMBO Group
- Procedure types (national, MRP, DCP, CP)
- Application types (full dossier, generic applications)
- Marketing authorisation documentation (eCTD)
- Competent authorities
- Case study
- Medical device classification
- Roles and responsibilities (authorities, notified bodies, European Commission, etc.)
- Route selection (with or without notified body involvement)
- Technical documentation: Requirements, risk management, clinical evaluation, etc.
- QM system as an integral part of device file
- Intended use and design changes
- Case study
- Overall concept: Regulatory vs. GMP documentation
- Identification of relevant GMP data for regulatory purposes
- Documentation principles (GDocP, ALCOA+ vs. document control)
- Roles and responsibilities
- Practical examples: Typical differences in terminology and interpretation
- Case study: From GMP to regulatory document
- Regulatory distinction: Medicinal products vs. medical devices
- Primary Mode of Action (PMOA): Definition, regulatory classification (EU vs. US), impact on regulatory strategy
- Intended use and PMOA: Case examples
- Regulatory strategy development
- Responsibility for placing products on the market
- Process thinking: Intended use vs. standardised criteria/validated processes
- Data integrity: ALCOA+ and audit trails
- Risk management: ICH Q9 vs. ISO 14971
- Supplier management and supplier risk assessment
- "Death by Change Control": The risk of product changes for combination products
- Use of computerised systems and AI
- Lifecycle management and product maintenance
- Inspection readiness and regulatory reality
- Practical implementation of responsibility demarcation agreements
In small groups, participants perform a structured high-level assessment of realistic combination product scenarios using a regulatory decision tree to determine product classification, PMOA, the applicable EU regulatory pathway. Key regulatory risks and uncertainties are then identified and prioritised using a simplified risk matrix. Results are subsequently discussed in a plenary session.
Welcome, introduction, expectations
Key guidelines and requirements (Focus: EU)
Key guidelines and requirements (Focus: EU)
- Medicinal products: EU GMP Volume 4, Annexes, selected ICH guidelines and more
- Medical devices: MDR/IVDR and annexes, ISO 13485/ISO 14971, roles and responsibilities, CE marking/EU Declaration of Conformity/UDI
- Combination products: MDR Article 1 and Article 117, Annex IX, borderline classification rules (Article 2 of Directive 2001/83/EC), EMA 259165/2019, EMA 37991/2019, outlook on FDA (unified approach), COMBO Group
Bio break
Regulatory Affairs I: Marketing authorisation process for medicinal products
Regulatory Affairs I: Marketing authorisation process for medicinal products
- Procedure types (national, MRP, DCP, CP)
- Application types (full dossier, generic applications)
- Marketing authorisation documentation (eCTD)
- Competent authorities
- Case study
Regulatory Affairs II: Conformity assessment of medical devices
Regulatory Affairs II: Conformity assessment of medical devices
- Medical device classification
- Roles and responsibilities (authorities, notified bodies, European Commission, etc.)
- Route selection (with or without notified body involvement)
- Technical documentation: Requirements, risk management, clinical evaluation, etc.
- QM system as an integral part of device file
- Intended use and design changes
- Case study
Lunch break
Documentation strategies using quality related data as a role model
Documentation strategies using quality related data as a role model
- Overall concept: Regulatory vs. GMP documentation
- Identification of relevant GMP data for regulatory purposes
- Documentation principles (GDocP, ALCOA+ vs. document control)
- Roles and responsibilities
- Practical examples: Typical differences in terminology and interpretation
- Case study: From GMP to regulatory document
Combination products: Regulatory strategy
Combination products: Regulatory strategy
- Regulatory distinction: Medicinal products vs. medical devices
- Primary Mode of Action (PMOA): Definition, regulatory classification (EU vs. US), impact on regulatory strategy
- Intended use and PMOA: Case examples
- Regulatory strategy development
- Responsibility for placing products on the market
Bio break
Combination products: Common pitfalls and solutions
Combination products: Common pitfalls and solutions
- Process thinking: Intended use vs. standardised criteria/validated processes
- Data integrity: ALCOA+ and audit trails
- Risk management: ICH Q9 vs. ISO 14971
- Supplier management and supplier risk assessment
- "Death by Change Control": The risk of product changes for combination products
- Use of computerised systems and AI
- Lifecycle management and product maintenance
- Inspection readiness and regulatory reality
- Practical implementation of responsibility demarcation agreements
Case studies/practical workshop
Case studies/practical workshop
In small groups, participants perform a structured high-level assessment of realistic combination product scenarios using a regulatory decision tree to determine product classification, PMOA, the applicable EU regulatory pathway. Key regulatory risks and uncertainties are then identified and prioritised using a simplified risk matrix. Results are subsequently discussed in a plenary session.
Recap and pending questions
End of the seminar
Downloads
Request the documents using our form.
Abbreviations-Drug Regulatory Affairs and CMC
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