Shaping the Future of EU Pharmaceutical Regulation: Current Framework, Reform, and Beyond

The European Union’s pharmaceutical regulatory framework has long been recognised by policymakers and experts alike as a global benchmark. It ensures that medicinal products are safe, effective, and accessible across the internal market. However, the rapidly evolving healthcare landscape, marked by technological innovation, growing public health demands, geopolitical tensions, and supply chain vulnerabilities, calls for critical reflection and reform. The European Commission has responded with the most significant legislative proposals in over two decades, aiming to make EU pharmaceutical law more flexible, responsive, and future proof.

In this context, the upcoming conference “Shaping the Future of EU Pharmaceutical Regulation: Current Framework, Reform, and Beyond” offers a unique and timely opportunity for stakeholders to come together and scrutinise not only the existing legal regime and the ambitious reform agenda currently on the table, chiefly represented by the Proposal for a Directive on the Union code relating to medicinal products for human use (COM(2023) 192 final) and the Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (COM(2023) 193 final), but also the broader regulatory ecosystem in which these reforms are unfolding.

The conference will also focus on parallel initiatives that are shaping the future of pharmaceutical policy and life sciences in the EU. These include the Critical Medicines Act, which aims to secure supply chains and enhance the EU’s resilience against medicine shortages; the Commission’s Recommendation on Antimicrobial Resistance, addressing one of the most pressing public health threats through coordinated action; and the Commission’s targeted initiatives to boost biotechnology and biomanufacturing, recognising their role in strengthening Europe’s strategic autonomy and fostering innovation in life sciences.

What you will learn

Attendees will leave with clear, practical knowledge about the EU pharmaceutical regulatory framework, the changes underway, and how these developments will affect their work.

Conference methodology

The conference will begin by exploring the pillars of the existing framework, highlighting the regulatory successes in promoting patient safety and innovation, while also addressing the structural deficiencies that require reform. Subsequent sessions will provide a deep dive into the legislative proposals presented by the Commission, evaluating their legal architecture and intended impact. A hallmark of the conference is the platform it provides for key stakeholders – national regulatory authorities, the pharmaceutical industry, patient advocacy groups, and legal experts – to express their views on the reform and assess its implications from their professional perspectives.

This event is not only a learning opportunity but also a strategic platform for dialogue and foresight. It is designed for a broad range of professionals:

• National authorities and regulators will gain clarity on their future roles, obligations, and opportunities to contribute to implementation.
• Industry professionals will deepen their understanding of upcoming regulatory changes, new compliance requirements, and how these changes may impact innovation pipelines, supply security, and market strategy.
• Patient associations and public health advocates will learn how the reform and accompanying initiatives aim to improve access to medicines, affordability, and patient-centred healthcare across the EU.
• Legal practitioners and pharmaceutical law experts will receive valuable insights into how the evolving legal landscape may influence regulatory advocacy, litigation, and compliance risk management.

This conference is designed for a diverse audience of professionals whose work intersects with pharmaceutical law, policy, and practice. Specifically, it is intended for:

• Senior officials and policymakers from national regulatory authorities and relevant ministries.
• Executives, regulatory affairs managers, legal counsel, and compliance officers from the pharmaceutical and biotechnology industries.
• Representatives of patient advocacy organisations and public health bodies.
• Legal professionals, including specialised pharmaceutical lawyers, litigators, and legal academics.
• Industry consultants, think tanks, and analysts focusing on health policy, innovation, and EU regulatory affairs.
• Members of European institutions, agencies, and stakeholders involved in pharmaceutical policy and governance.

Project number: 2550701

Course venue
Fondation Universitaire
11, Rue d’Egmont 11
1000 Brussels (BE)

Programme Organiser
Ms Elisa Dolci
Tel: +352 691 108 038
e.dolci@eipa.eu

Fee
The fee includes documentation and refreshments. Lunches, a reception or dinner are included if mentioned in the programme. Accommodation and travel costs are at the expense of the participants or their administration.

Discounts
EIPA member fee
EIPA offers a discount to all civil servants working for one of EIPA’s supporting countries, and civil servants working for an EU institution, body or agency.

Who are the supporting countries?
Civil servants coming from the following EIPA supporting countries are entitled to get the reduced fee: Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden.

For all other participants, the regular fee applies.

Early bird discount
The early bird discount is not cumulative with other discounts or promo codes, except for the EIPA member fee.

Loyalty coupon
As a token of appreciation we offer all our participants a loyalty coupon for one of our future courses. The offer can be shared with colleagues and relevant networks. The coupon will expire one year after its release. This discount is not cumulative with other discounts, except for the EIPA member fee.

Meals
Dietary preferences can be indicated on the registration form.

Confirmation
Confirmation of registration will be forwarded to participants on receipt of the completed online registration form.

Payment
Prior payment is a condition for participation.

Cancellation policy
For administrative reasons you will be charged €150 for cancellations received within 15 days before the activity begins. There is no charge for qualified substitute participants.

EIPA reserves the right to cancel the activity up to 2 weeks before the starting date. In that case, registration fees received will be fully reimbursed. EIPA accepts no responsibility for any costs incurred (travel, accommodation, etc.).

A few days before the start of the course you will receive the log-in details for accessing the course materials. You can log in here.