Join Health Action International and Public Eye (previously called the Berne Declaration) on Friday, 30 September, for a public conference to debate issues related to (1) the globalisation of clinical trials and ethics, (2) recent developments on clinical trial data transparency, (3) evidence generation requirements for marketing authorisation and new regulatory paradigms, such as adaptive pathways, and (4) the way forward for needs-driven biomedical research. Each panel session will consist of 3 to 4 short presentations followed by a Q&A discussion with the audience. Lunch will be provided. Refreshments will be served at the end of the day.

LOCATION
Salle communale du Môle, rue du Môle 21, Geneva, Switzerland. (See map.)

REGISTER
Please RSVP your attendance (also indicating whether you will join us for lunch) by 28 September, 2016, to Patrick Durisch at patrick.durisch@publiceye.ch.

DRAFT PROGRAMME (additional speakers will be confirmed)
9.00–9.10: Welcoming remarks
Patrick Durisch, Health Policy, Public Eye

9.10–9.30: Keynote address
Tom Jefferson, Honorary Research Fellow, Centre for Evidence Based Medicine and Cochrane Acute Respiratory Infections Group

9.30–10.50: Panel session 1–Globalisation of clinical drug trials & ethics
– Ayman Sabae, Right to Health Researcher, Egyptian Initiative for Personal Rights
– Patrick Durisch, Health Policy, Public Eye
– Samia Hurst, Director, Institut Ethique Histoire Humanités (iEH2), University of Geneva
– Françoise Jaquet, Head, Clinical Trials Division, Swissmedic

10.50–11.10: Break

11.10–12.30: Panel session 2–Transparency & access to clinical trial data
– Tom Jefferson, Honorary Research Fellow, Centre for Evidence Based Medicine and Cochrane Acute Respiratory Infections Group
– Jan Stadler, Legal Officer, Inquiry Coordination Unit, European Ombudsman
– Ancel.la Santos Quintano, Policy Advisor, Health Action International
– Ghassan Karam, International Clinical Trials Registry Platform, World Health Organization

12.30–13.30: Lunch (provided)

13.30–13.50: Keynote address
Teresa Alves, International Policy Advisor, La Revue Prescrire

13.50–15.10: Panel session 3–Evidence generation for marketing authorisation & adaptive pathways
– Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency
– Beate Wieseler, Head, Drug Assessment Department, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
– Jörg Schaaber, Past-president, International Society of Drug Bulletins and Managing Director, BUKO-Pharma Kampagne
– Mónica Cavagna, BEUC (European Consumers’ Organisation)
– Sophie Le Pallec, Chair, Amalyste

15.10–15.30: Break

15.30–16.50: Panel session 4–The way forward for needs-driven public health research
– Silvio Garattini, Founder, Mario Negri Institute for Pharmacological Research
– Joel Lexchin, Professor, Faculty of Health, York University (Toronto, Canada)
– Katy Athersuch, Policy Adviser, Médecins Sans Frontières Access Campaign
– Nathalie Strub-Wourgaft, Medical Director, Drugs for Neglected Diseases Initiative (DNDi)

16.50–17.15: Keynote address
Ruth Dreifuss, Co-chair, United Nations Secretary-General’s High-Level Panel on Access to Medicines

17.15–17.30: Closing remarks
Tim Reed, Executive Director, Health Action International

17.30: Happy Hour

This event received funding under an operating grant from the European Union’s Health Programme (2014–2020).