Workshop direction: M. Lindquist, R. Chandler, C. Heneghan, R. Leone
Current approval of medicines is failing to detect the signals of harms within the evidence-base. Problems within the regulatory system have often led to the approval of ineffective and harmful drugs. Postmarketing is largely ineffective in detecting problems once a drug is on the market. New solutions to address these problems are needed, however, finding solutions to better detect, analyse and report harms will not be straightforward. Advance the detection and reporting/safety signals for medicines is critical to providing better healthcare for all.
This three-day forum focuses on the tasks ahead in order to provide solutions for better detection, analysis and reporting of harms.
Invited individuals have expertise
and/or experience in:
The next generation of problem solvers is also included to contribute to the solutions which will go far into the future.
Arrival of participants. All the invited persons must register in this website inserting their contact details and the details of their flights.
The transfer from the airport (Palermo or Trapani) to Erice will be organized by the Ettore Majorana Centre according to the information provided upon registration.
08:30 |
Registration & Coffee |
09:00 |
Welcome & introductions |
Carl and Marie open to discuss the purpose, aims and achievements for the meeting |
|
09:30 - 11:00 |
Identify problems with pre-marketing approvals |
Chair: Rebecca Chandler |
|
1A - Asger Sand Paludan-Muller |
|
1B - |
|
1C - Peter Gotzsche |
|
11:00 - 11:30 |
Break / Coffee |
11:30 - 13:00 |
Group Workshops 1: Brainstorm on the problems |
13:00 - 14:00 |
Lunch |
14:00 - 15:30 |
Identify potential solutions to the problems of pre-marketing approvals |
Chair: Robin Ferner |
|
2A - Tom Jefferson |
|
2B - Catherine Riva |
|
2C - Jeff Aronson |
|
15:30 - 16:00 |
Break / Coffee |
16:00 - 17:30 |
Group Workshops 2: Brainstorm on potential solutions |
17:30 - 18:30 | Sum up/overview of the day |
Chair: Carl Heneghan |
|
Group A, B, C nominated spokesperson |
09:00 - 10:30 | Identify problems with post-licensing |
Chair: Jamie Coleman | |
3A - Gilles Mignot | |
3B - Florence van Hunsel | |
3C - Joan-Ramon Laporte | |
10:30 - 11:00 | Break / Coffee |
11:00 - 12:30 | Group Workshops 3: Brainstorm on the problems |
12:30 - 14:00 | Lunch |
14:00 - 15:30 | Identify potential solutions to post-licensing problems |
Chair: Saad Shakir | |
4A - Mick Foy | |
4B - Luca Li Bassi | |
4C - David Healy | |
15:30 - 16:00 | Break / Coffee |
16:00 - 17:30 | Group Workshops 4: Brainstorm on potential solutions |
17:30 - 18:30 | Sum up/overview of the day |
Chair: Marie Lindquist | |
Group A, B, C nominated spokesperson | |
19:30 | Event Dinner |
9:00 - 10:30 | Identify the problems/ barriers to communicating/disseminating in pharmacovigilance |
Chair: Helen McDonald | |
5A - | |
5B - Kath Sansom | |
5C - Faye Kirkland | |
10:30 - 11:00 | Coffee |
11:00 - 12:30 | Group Workshops 5: Brainstorm on the problems |
12:30 - 14:00 | Lunch |
14:00 - 15:30 | Identify potential solutions to the problems of communication |
Chair: Kim Witzak | |
6A - Serena Tinari | |
6B - Anthony Cox | |
6C - Bruce Hugman | |
15:30 - 16:30 | Group reflections |
Chair: Carl Heneghan | |
A, B, C nominated spokesperson; Discussion and next steps | |
Close: Marie Lindquist |
Departure of participants. The transfer to the airport (Palermo or Trapani) will be organized by the Ettore Majorana Centre.
Meeting point and time for the departure transfer will be displayed on a panel at the E. Majorana Centre in San Rocco hall, according to the information given upon registration.
Rebecca Chandler
Jeff Aronson
Jamie Coleman
Anthony Cox
Nick De Vito
Kay Dickersin
Ivor Ralph Edwards
Robin Ferner
Mick Foy
Su Golder
Peter Gotzsche
David Healy
Carl Heneghan
Bruce Hugman
Tom
Jefferson
Lars Jorgensen
Faye Kirkland
Joan-Ramon Laporte
Tianjing Li
Luca Li Bassi
Marie Lindquist
Helen MacDonald
Giles Mignot
Georgia Richards
Catherine Riva
Gerard Ross
Asger Sand Paludan-Muller
Kath Sansom
Daniele Sartori
Saad Shakir
Serena Tinari
Florence van Hunsel
Kim Witczak
*to be onfirmed