Improving the detection, analysis and reporting of harms in medicines

October 06 th - 10 th 2019

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:

  • Pharmacovigilance
  • Drug regulation
  • the reporting and communicating of medicine harms 

The next generation of problem solvers is also included to contribute to the solutions which will go far into the future.




Timetable

Sun, 06 th Oct 2019

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.

Mon, 07 th Oct 2019

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


Tue, 08 th Oct 2019

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

Wed, 09 th Oct 2019

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

Thu, 10 th Oct 2019

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.


Documents

Click on the name of the file to download it


Attendees

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