Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Dr Fatima Bicane
Pharma Deutschland
GMP-RELATED CHANGES AND AMENDMENTS IN THE NEW REGULATION AND DIRECTIVE
Zielgruppe
- Professionals involved in GMP-relevant activities within the pharmaceutical Industry
- Personnel responsible for preparing for or implementing regulatory updates in their organisations
- Anyone who wants an overview of the expected GMP-related changes proposed in the revision of EU Medicines Legislation
Zielsetzung
On 10th December 2025 co-legislators reached a provisional agreement on revamping the EU’s pharmaceutical policy framework, to boost competitiveness, innovation and security of supply.
The reform aims to improve availability, accessibility and affordability of medicines, while promoting higher environmental standards and increasing competitiveness of the pharmaceutical industry in the EU. Key elements include reducing administrative burdens, promoting innovation and competitiveness, addressing shortages, ensuring environmental sustainability and tackling antimicrobial resistance.
There are also GMP-relevant changes, which will be discussed in this Live Online Session.
The reform aims to improve availability, accessibility and affordability of medicines, while promoting higher environmental standards and increasing competitiveness of the pharmaceutical industry in the EU. Key elements include reducing administrative burdens, promoting innovation and competitiveness, addressing shortages, ensuring environmental sustainability and tackling antimicrobial resistance.
There are also GMP-relevant changes, which will be discussed in this Live Online Session.
Programm
Status and Overview of the Revision of the Pharmaceutical Legislation in the EU
- Part I: Legal Instrument and legislative process
- Part II: New Directive of the European parliament and the council on the Union code relating to medicinal products for human use
- Part III: New Regulation of the European parliament and the council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency
GMP-relevant Consequences from Directive and Regulation
- The manufacturer, the QP and the new directive 2023/192
- The manufacturer, the QP and the new regulation 2023/193
- Discussion and observations
- The QP and the new Annex III to directive 2023/192
- ECA-EQPA comments
- Early and expected impacts on GMP rules and applicability
- Conclusion
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At 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 EUR 590
APIC Members EUR 640
Non-ECA Members EUR 690
EU GMP Inspectorates EUR 590
The conference fee is payable in advance after receipt of invoice.
The Registration does not include ECA Membership.
ECA Members EUR 590
APIC Members EUR 640
Non-ECA Members EUR 690
EU GMP Inspectorates EUR 590
The conference fee is payable in advance after receipt of invoice.
The Registration does not include ECA Membership.
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:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
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:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 17 March 2026
13:00–17:45 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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