EU PHARMA FORUM

OPENING OF THE CONFERENCE   

08:30 – 09:00

Registration

09:00 – 09:05

Opening Remarks

Silva Stazić, Paradigma Agency

09:05 – 09:10

Introduction into event

Ana Soldo, President of Croatian Chamber of Pharmacists

09:10 – 09:20

The role of the EU Pharma Package for Croatia

• What can we expect from the EU Pharma Package for the Croatian healthcare system?

Maja Cvetojević, Ministry of Health of Croatia

Session 1 – The future of the European Health Union

09:20 – 09:30

Single European market for medicines

• Reform of EU Pharmaceutical Legislation: How will the Pharma Package impact the European and Croatian healthcare systems and patients?

Keynote speaker: Tomislav Sokol, Member of EU Parliament

09:30 – 09:40

Croatian perspective on the EU Pharma Package

• HALMED’s role in the context of the new pharmaceutical regulatory framework

Keynote speaker: Siniša Tomić, Head of Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

09:40 – 09:50

Slovenia’s perspective on the EU Pharma Package

• JAZMP’s role in the context of the new pharmaceutical regulatory framework

Keynote speaker: Momir Radulović, Director of Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Session 2 – Regulatory Data Protection and Proposal for a new incentive’s framework

09:50 – 10:00

Regulatory Data Protection and Proposal for a new incentive’s framework

Keynote speaker: Nathalie Moll, EFPIA and Goranka Marušić Kontent,HALMED

10:00 – 10:40

Panel discussion: “Ensuring the availability of medicines while supporting the competitiveness of the EU’s pharmaceutical industry”

• Discussion on the EU’s proposal to shorten regulatory data protection and orphan market exclusivity baseline for innovative pharmaceuticals
• Implications & analysis

Panel participants: Soon

10:40 – 10:55 COFFEE BREAK

Session 3 – The Role of Legislation on Investment for Innovation

10:55 – 11:05

The Role of Legislation on Investment for Innovation – Introduction into discussion

Keynote speaker: Claus Runge, Bayer

11:05 – 11:45

Panel discussion: “Challenges and opportunities in drugs availability”

• Mandatory drug launch across the EU member states
• Impact on member states, particularly regarding orphan drugs
• Obligation to launch orphan drugs process
• Member states’ concerns about imposed regulations
• How to build on past legislations to incentivize more innovation?
• What are the most important EU legislations pending adoption and what recommendations participants must make sure these incentivise innovation and attract investments.
• What are the legislations ahead and how can these be leveraged?

Panel participants: Soon

Session 4 – The Role of Generic and Biosimilar Medicines in Enhancing Access

11:45 – 11:55

The Role of Generic and Biosimilar Medicines in Enhancing Access – Introduction into discussion

Keynote speaker: Adrian van den Hoven, General Director of Medicines for Europe

11:55 – 12:35

Panel discussion: Will the EU pharmaceutical legislation reform lower the price of the medicines in the EU and ensure new drugs are more accessible?

• Analysis of the patent expiration gap and generic availability
• Discussion on improving access to medications
• Bridging the gap: Ensuring equitable access to medicines across the EU
• The Role of Generic and Biosimilar Medicines in Enhancing Access

Panel participants: Soon 

12:35 – 13:35 (60 minutes) LUNCH BREAK

Session 5 – Clinical Trials in the EU & Innovative Therapies for Smaller Markets

13:35 – 13:45

Clinical Trials in the EU & Innovative Therapies for Smaller Markets – Introduction into discussion

Keynote speaker: Soon

13:45 – 14:25

Panel discussion: “What can we do to become an attractive market for clinical trials, either as Croatia or as Europe?

• Examination of the need for innovative therapies in smaller markets
• Critique of current reforms and their failure to achieve this goal
• Overview of the regulatory impact on clinical trials
• Discussion on how increased costs might deter innovative research

Panel participants: Soon

Session 6 – Challenges in health market supply chain

14:25 – 14:35

Challenges in health market supply chain – Introduction into session

Keynote speaker: Yannis Natsis, European Social Insurance Platform (ESIP)

14:35 – 15:15

Panel discussion: The EU response to the health market supply chain

• Can the EU respond to all challenges in the potential new health crisis
• Resilience and cohesion of the EU health market
• Towards a unified future: Strengthening health systems in Europe
• Role of health insurance in the formation of a single European health market in the medicines’ availability

Panel participants: Soon

Session 7 – Closing Remarks and Q&A

15:15 – 15:30

Closing remarks: Ana Soldo, President of Croatian Chamber of Pharmacists

• Summary of key points discussed
• Next steps and action items
• Q&A session

15:30 – 16:00 After Work Networking – Coffee break