ExPRESS Yourself! Expert Patients and Researchers EURORDIS Summer School Barcelona, Spain June 6-10, 2016

Transcription

1 ExPRESS Yourself! Expert Patients and Researchers EURORDIS Summer School Barcelona, Spain June 6-10, 2016 A capacity building programme for patient representatives and researchers on information and access to orphan, paediatric, advanced therapies and health technology assessment. Co-organised in 2016 with: Additional support provided by:

2 Programme Committee Members: COST ACTION BM1207 Nathalie Goemans Elizabeth Vroom The Summer School was co-organised with: COST Action BM2107 The European Medicine s Agency Platforma Malaties Minoritàries Co-funding: This Summer School has received funding under an operating grant from the European Union s Health Programme ( ). Financial support also provided by: AFM Telethon COST Action BM1207 ECRIN IA Inserm Platforma Malaties Minoritàries Venue: Hotel Front Maritim Barcelona, Spain EURORDIS Nancy Hamilton EURORDIS Training Manager nancy.hamilton@ Platforme Maladies Rare 96 rue Didot Paris, France www. COST Action BM1207 LUMC, Albinusdreef ZA Leiden The Netherlands A.M.Aartsma-Rus@lumc.nl Local Organiser: Iolanda Arbiol Platforma Malaties Minoritàries EUROPEAN MEDICINES AGENCY Nathalie Bere Maria Mavris Monica Ensini EURORDIS Nancy Hamilton Virginie Hivert Yann Le Cam PLATFORMA MALATIES MINORITÀRIES Josep Torrent

3 Monday June 6, :00-11:30 Session for Researchers: the EMA framework dedicated to academics: and Nathalie Goemans 12:00 Registration opens 12:30-12:40 Welcome: Nancy Hamilton and Virginie Hivert 12:40-13:00 Introduction to ExPRESS 2016: Yann Le Cam and Josep Torrent 13:00-14:30 Networking Session, trainees introduce themselves: and Elizabeth Vroom 14:30 15:00 Review of Key Concepts in Clinical Trial Methodology: Josep Torrent 15:00 15:30 COFFEE BREAK 15:30-17:30 Break-out Session on Clinical Trial Methodology: Josep Torrent, Cari Pontes (TBC) Rob Camp, Eric Koster, Elizabeth Vroom, Elisa Ferrer, Manel, Annemieke Aartsma-Rus (Four groups of 12 people) 17:30-18:00 Feedback Session: 5/6 minutes/group 18:00-18:15 Daily Wrap-Up: Elizabeth Vroom 19:00-22:00 Welcome Dinner Within Walking Distance of Hotel

4 Tuesday June 7, :45-08:50 Daily Overview: Nancy Hamilton 08:50-09:15 Review of Key Concepts on Ethical Considerations: Eric Koster 09:15-10:45 Break-out Session on Ethics Committee Eric Koster, Rob Camp, Josep Torrent, Elizabeth Vroom 10:45-11:15 COFFEE BREAK 11:15-11:45 Feedback Session: 5/6 minutes/group 11:45-12:15 European Clinical Research Infrastructures Network: Christine Kubiak 12:15-12:45 COST Actions: 12:45-13:00 Update on EURORDIS: Virginie Hivert 13:00-14:00 LUNCH 14:00-15:00 When patients take the lead Julian Isla-Gomez 15:00-16:00 Workshop on EU Funding opportunities for Researchers and Patient Expert: Mathieu Boudes 16:15-16:30 Daily Wrap-Up: 16:30-17:30 with afternoon tea Laboratory Experiment:

5 Wednesday June 8, :45-08:50 Daily Overview: Nancy Hamilton 08:50-09:30 Expert Involvement in European Medicines Agency Committees and Working Groups: Nathalie Bere 09:30-11:00 Round Table on EMA Committees: Kristina Larsson, Josep Torrent, Nicolas Ferry, Patrick Salmon 11:00-11:15 COFFEE BREAK 11:15-13:15 Mini COMP & SAWP (designation, PA, maintenance of orphan status) + How to get prepared: Nathalie Bere, Maria Mavris, Kristina Larsson, Elisa Ferrer 13:15-14:15 LUNCH 14:15 15:00 Review of Key Concepts in Benefit Risk "How to build a dossier" and Marketing authorization: Patrick Salmon 15:00 15:30 Two perspectives on benefit risk: Regulator and Patient: Patrick Salmon and 15:30-17:00 Workshop on Health Technology Assessment: Edmund Jessop 17:00-17:15 Daily Wrap-Up: Maria Mavris

6 Thursday June 9, :45-08:50 Daily Overview: Nancy Hamilton 08:50-09:15 Review of Key Concepts in Pharmacovigilance: 09:15 10:45 Mock written PRAC Consultation with Patients Nathalie Bere, Maria Mavris 10:45 11:15 COFFEE BREAK 10:15-11:45 Break-out Session on Pharmacovigilance: PRAC safety communication and SAG Eric Koster,, Rob Camp, Maria Mavris, Nathalie Bere 11:45 12:15 Feedback Session: 5/6 minutes/group 12:15-12:45 Review of Key Concepts in Post Marketing, Access and Health Technology Assessment: Driss Berdaï, Solange Rohou, François Maignen, Edmund Jessop 12:45-13:45 LUNCH 13:45-15:00 Break-out Session on HTA and Market Access: Edmund Jessop, Driss Berdaï, Solange Rohou, François Maignen 15:00-15:30 Feedback Session: 5/6 minutes/group 15:30-16:00 Round table of National Competent Authorities:) François Maignen, (TBC) Lena Ring(TBC,) 16:00-16:15 Daily Wrap-Up:

7 Friday June 10, :55-09:00 Daily Overview: Nancy Hamilton 09:00-09:45 New Initiatives in Early Dialogue / EUNetHTA: 09:45 10:30 Introduction to MoCA: Jean-Louis Roux, Elisa Ferrer, Chris Sotirelis 10:30-11:00 COFFEE BREAK 11:00-12:00 Social Media for Patients and Researchers Tom Koukoulis, Denis Costello, Rob Camp 12:00-13:00 Wrap-Up Session: How do you see yourself acting based on your participation in the training course Josep Torrent and Fernando de Andres-Trelles 13:00-14:00 Farewell Lunch