Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Dr Peter Stilkenböhmer
Bela-Pharm
An Overview on the New EU Regulations 2025/2154 and 2025/2091
In around three and a half hours, two experienced speakers will present key content, interpretations and practical aspects of the new EU Regulations 2025/2154 and 2025/2091. Participants will have the opportunity to ask their own questions and discuss them with the experts.
In around three and a half hours, two experienced speakers will present key content, interpretations and practical aspects of the new EU Regulations 2025/2154 and 2025/2091. Participants will have the opportunity to ask their own questions and discuss them with the experts.
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 Live Online Training, 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
Question and Answer Session
A live Q&A Session will give you the possibility to interact with the speakers and get answers to your Questions.
A live Q&A Session will give you the possibility to interact with the speakers and get answers to your Questions.
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members € 590
APIC Members € 690
Non-ECA Members € 690
EU GMP Inspectorates € 490
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Ms Sarah Schmidt (Operations Director), +49(0)62 21 84 44 16, s.schmidt@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec (Organisation Manager), +49(0)62 21 84 44 24, nemec@concept-heidelberg.de.
Datum & Uhrzeiten
Wed, 06 May 2026, 9:00 – 12:30 h
All times mentioned are CEST
All times mentioned are CEST
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
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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