<> Date:  7 October 2022   |   09:00 - 17:00 (Eastern European Time – Sofia, Bulgaria)

<> Topic: IMPACT OF EU HTA REGULATION ON RARE DISEASES AND ORPHAN DRUGS

<> Format: hybrid event (in-person in Sofia (Bulgaria) and online streaming)

<> Summary:  The central topic of this event is the recently adopted EU Regulation on HTA and its impact on rare diseases and orphan drugs. This document is considered a key milestone to all rare diseases and orphan drugs stakeholders in Europe, as this is largely meant to improve access to innovative treatments. The regulation is expected to strengthen the quality of HTA across the EU and ensure the long-term sustainability of EU HTA cooperation.

The 9th International Symposium on HTA aims to be a platform for representatives of health authorities, patient organizations, industry and European reference networks for rare diseases to share best practices and foster collaboration in light of the upcoming implementation of the EU Regulation.

<> Language: The symposium will be held in English.

<> Access and registration:

- On site attendance in Sofia (Bulgaria): By personal invitation from the Organizing committee  

- Virtual attendance (academic, health authorities, patient groups representatives): Please, register by completing the short form bellow. The organizing committee will send detailed instructions how to connect and participate online in the event.

- Industry representatives: Please, contact the Organizing committee at g.stefanov@raredis.org 

<> Organizers:

This event is jointly organized by the Institute for Rare Diseases (IRD) - Bulgaria and the International Conference on Rare Diseases and Orphan Drugs (ICORD) 

<> For more infromation and questions: g.stefanov@raredis.org 

Draft Agenda by 29.09.2022

| REGISTRATION & WELCOME COFFEE (9:00 – 9:30 h)

| Morning session (9:30 - 12:00 h)

“EU HTA REGULATION – INTERMEDIATE CHALLENGES AND TASKS AT EU AND NATIONAL LEVEL”

Moderated by Domenica Taruscio (ICORD) and Rumen Stefanov (IRD/ICORD)

Marcus Guardian (EUnetHTA): EU HTA Regulation – Intermediate Challenges and Tasks at EU Level

Francis Arickx (Belgium): The case of Belgium

Marco Marchetti (Italy): The case of Italy

Iga Lipska (Poland): The case of Poland

Ilko Getov (Bulgaria): The case of Bulgaria

| LUNCH BREAK (12:00 – 13:30 h)

| Afternoon sessions (13:30 - 16:40 h)

“EU HTA REGULATION – IMPACT ON THE ACCESS TO INNOVATIVE THERAPIES”

Moderated by Domenica Taruscio (ICORD) and Rumen Stefanov (IRD/ICORD)

Sheela Upadhyaya (UK): The case of orphan therapies

Angelica Carletto (Italy): Access to orphan drugs in Italy and the role of AIFA

Oriol Solà-Morales (Spain): The case of cancer therapies

Panel discussion

| COFFEE BREAK (15:30 – 16:00 h)

“EU HTA REGULATION – IMPACT ON ACCESS IN BULGARIA”

Moderated by Luka Chichov (IQVIA)

Panel discussion: 

Deyan Denev (ARPharM)

Iliya Nikolov (ISPOR Bulgaria)

|  AWARD OF CERTIFICATES & CLOSURE (16:40 – 17:00 h)