Practical preparation of compliant, sound documentation for drug- device combination products
Webcode 26112456
Dr. Matthias Kühnle
Freelance Health Care Consulting, Hochdorf
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
B2B Medical GmbH, Rastatt, GERMANY
Head of Quality Management
Senior People Leader with 10+ years of experience in the pharmaceutical and medical device industry, helping organizations navigate change, transformation, and regulatory challenges.
More information please click here.
24/11/2026
24/11/2026
from 9:00 am to 5:00 pm CET - online training
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
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.
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.
After having participated, you will be equipped with
Welcome, introduction, expectations
Bio break
Lunch break
Recap and outstanding questions
End of the seminar
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