GMP-Update: Reform of EU Pharmaceutical Legislation - Live Online Session
The Commission Proposal to revise EU Medicines Legislation
Tuesday, 17 March 2026 13.00 - 17.45 h
Course No. 22608
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Fatima Bicane
Pharma Deutschland
GMP-RELATED CHANGES AND AMENDMENTS IN THE NEW REGULATION AND DIRECTIVE
Target Group
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
Objectives
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.
Programme
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
Further Information
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.
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.
Testimonials
