Medicines for Europe 24th Regulatory Affairs Conference 2026

Generics and biosimilars Initiative

Building trust in cost-effective treatments

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Medicines for Europe 24th Regulatory Affairs Conference 2026

INICIO/Congresos | Posted 29/09/2017 0 Post your comment

24th Regulatory Affairs Conference 2026
26‒27 February 2026
Hilton Amsterdam Airport Schiphol
Amsterdam, The Netherlands

What’s next in the regulatory landscape for generic medicines?

Join us for the 2026 Regulatory & Scientific Affairs Conference on 26-27 February in Amsterdam; stay informed and your share your views! Our 2026 Conference comes at a pivotal moment – after the pharmaceutical legislation outcome is decided. The industry and regulators face years of implementation and adaptation. The Conference will address preparing for upcoming changes, plus digitalisation, new responsibilities, and environmental requirements.

Key stakeholders, including leading regulators, industry experts, and European institution officials, will come together to engage in discussions and debate on the regulatory challenges and opportunities that lie ahead.

Looking to the future – What changes can we expect in the pharmaceutical environment in the years ahead?

Update on the Revision of the Pharmaceutical Legislation-where are we headed?
Critical Medicines Act and Biotech Act as tools to increase EU competitiveness and security of supply
Horizontal legislation and pharmaceutical specific legislation – how to achieve a coherent policy and address the impact on access to medicines?
Implementation of the EMA & HMA Strategy 2028

How to transition smoothly to modern methods of patient access to medicinal product information.

Watch this space! Changes in pharmaceutical legislation significantly affect operational activities of companies

The future implementation of the ASMF certification process and its co-existence with the EDQM’s CEP
Stronger quality, steady supply: navigating new regulatory requirements for sustainable access
Greater influence of competent authorities on the market and business decisions because of new legal provisions

Handling the life cycle management of medicinal products in the future

The Implementation of the revised Variations Regulation and Variations Classification Guideline
Opportunity to digitalise variation reporting via a database

The next five years in Regulatory Affairs

How to prepare for new challenges and translate them into internal business processes
CMDh and EMA work plans until 2028- what future opportunities are there for the off-patent sector?

Three webinars

Horizontal environmental legislation and the impact on pharmaceutical products
Say goodbye to the Art 57 database- the decommissioning of XEVMPD, PMS data enrichment and validation, the PMS API, and its effects on ESMP and ePI.
Pharmacovigilance – Signal detection and safety label changes

For more details, visit: www.medicinesforeurope.com/RAC26