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

The EU’s pharmaceutical framework has long been a global benchmark for safety, innovation, and access to medicines. Yet rapid scientific advances, growing public health needs, and persistent supply challenges now demand significant reform.

In response, the European Commission has tabled its most ambitious legislative package in over two decades. The proposed Directive and Regulation aim to modernise EU pharmaceutical law, balancing patient access, innovation, competitiveness, and strategic autonomy. Alongside this, initiatives such as the Critical Medicines Act, measures on antimicrobial resistance, and actions to strengthen biotechnology and biomanufacturing will further shape Europe’s health and life sciences landscape.

Against this backdrop, the conference “Shaping the Future of EU Pharmaceutical Regulation: Reform, Stakeholder Perspectives, and Legal Challenges” offers a timely platform to discuss the drivers, objectives, and consequences of reform. It begins with a keynote address outlining the crossroads at which the EU pharmaceutical system stands today. The first session then provides insights from senior European Commission officials on the Union’s legislative priorities and their intended impact on patient access, innovation, and competitiveness. The afternoon sessions give the floor to patient organisations, industry representatives, and legal practitioners, who will share their perspectives on how the reforms should be implemented, what challenges they may create, and what risks or opportunities they hold for different stakeholders. Each session includes substantial discussion with the audience, ensuring an interactive exchange.

What will you learn?

• A clear understanding of the European Commission’s pharmaceutical reform proposals and how they will reshape access, innovation, and regulatory oversight.
• Insights into how patient associations and the pharmaceutical industry view the ongoing debate around affordability, availability, and competitiveness.
• An overview of the legal and compliance challenges arising from the forthcoming legislative package, and how they may affect litigation, regulatory advocacy, and compliance management

Course methodology

The event is delivered fully online and is structured around thematic sessions. Each session features expert presentations followed by open discussion, enabling participants to engage directly with policymakers, industry leaders, legal experts, and patient advocates. This combination of structured input and interactive dialogue ensures that participants gain both authoritative insights and practical perspectives.

This conference is both a learning opportunity and a forum for forward-looking exchange. Participants will:

• Gain clarity on the EU’s legislative priorities and their likely impact on health systems, industry, and regulatory authorities.
• Anticipate how reforms may affect their professional responsibilities, whether in policy design, regulatory oversight, compliance, or advocacy.
• Hear directly from patients, industry, and legal practitioners about the practical challenges of implementing reform.
• Build foresight on how the pharmaceutical framework will evolve in the coming years, enabling better preparation for strategic decisions.

This event is designed for professionals whose work intersects with pharmaceutical law, policy, and practice, including:

• Senior officials and policymakers from national regulatory authorities and ministries.
• EU institutional staff and policy officers involved in health and pharmaceutical governance.
• Regulatory affairs managers, compliance officers, and legal counsel in the pharmaceutical and biotechnology industries.
• Patient organisations, public health advocates, and healthcare NGOs.
• Legal practitioners, litigators, and academic experts specialising in EU pharmaceutical and health law.
• Consultants, analysts, and think tanks focusing on health policy, regulatory affairs, and innovation strategy.

Project number: 2550701

Online Course
For this online course we make use of Zoom

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

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.

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 € 50 for cancellations received within 7 days before the activity begins. There is no charge for qualified substitute participants.

EIPA reserves the right to cancel the activity up to 1 week before the starting date. In that case, registration fees received will be fully reimbursed.

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.