Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referierende
Dr Peter Stilkenböhmer
Bela-Pharm
Two experienced speakers will present key content, interpretations and practical aspects of the new EU Regulations 2025/2154 and 2025/2091.
Zielgruppe
The Training is addressed to:
- Qualified Persons (QPs) and Responsible Persons for Veterinary Medicinal Products
- QA/QC and Regulatory Affairs Professionals in the Veterinary and API Sector
- Manufacturing and Production Managers, including Sterile Products
- API Manufacturers, Suppliers, and Contract Manufacturers
- Auditors in the field of Veterinary Medicinal Products
- Companies and Individuals preparing for implementation of the New EU Veterinary GMP Regulations
Zielsetzung
In this Recording, participants will:
- Understand the EU's completed legal framework for veterinary medicinal products and related APIs
- Identify what has changed and what remains the same under the new veterinary GMP regulations
- Clarify the applicability of Q&As, MRAs, PIC/S and ICH in the new regulatory context
- Understand the specific requirements for QP certification, sterile manufacturing and the Site Master File
- Recognise potential national differences despite the existence of directly applicable EU regulations
- Learn practical approaches for managing the transition and implementing the new requirements
- Gain insight into typical challenges and best practices from examples of industry implementation
Background
On 17 October 2025, the European Commission published two new GMP Implementing Regulations: (EU) 2025/2091 for veterinary medicinal products, and (EU) 2025/2154 for active substances used as starting materials in veterinary medicinal products. These regulations implement the requirements of Regulation (EU) 2019/6. These legally binding Regulations will take effect on 16 July 2026, replacing the former veterinary GMP provisions in EudraLex Volume 4 and establishing an independent regulatory framework for veterinary GMP.
On 17 October 2025, the European Commission published two new GMP Implementing Regulations: (EU) 2025/2091 for veterinary medicinal products, and (EU) 2025/2154 for active substances used as starting materials in veterinary medicinal products. These regulations implement the requirements of Regulation (EU) 2019/6. These legally binding Regulations will take effect on 16 July 2026, replacing the former veterinary GMP provisions in EudraLex Volume 4 and establishing an independent regulatory framework for veterinary GMP.
Programm
New EU Regulations for Veterinary Medicinal Products & Related APIs
- The veterinary medicinal legal framework is now complete – overview
- Applicability of Q&As, MRAs, PIC/S, ICH
What is New, What Stayed Unchanged
- The language – does it matter?
- QP certification
- Production of sterile veterinary medicinal products
- Site Master File
- National differences despite EU regulations?
Managing the Change - Practical Experience/Implementation – Examples
- How to implement the new EU veterinary GMP requirements in practice
- Key changes, challenges and solutions
- Lessons learned from real-life implementation
Weitere Informationen
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Ms Sarah Schmidt, +49 62 21 84 44-16, s.schmidt@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec, +49 62 21 84 44-24, nemec@concept-heidelberg.de.
Recording from 6 May 2026
Duration of recording: 2h 45m
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 490,- |
| APIC Member Discount*: | € 690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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