Workshop on patient-support programmes (PSPs) and market-research programmes (MSPs) – Understanding the diversity of such programmes and the management of safety information

• Date:
  Friday, 7 June 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This workshop's objective is to bring together stakeholders responsible for the protection of public health and the conduct of PSPs and the MRPs with the following objectives: understanding the spectrum of programmes that fall under the terms of PSPs and MRPs and the type of safety information that is collected in those programmes; assessing the optimum way to collect safety data from PSPs and MRPs. Registration by invitation only. Registration closed.

Documents

Agenda - Workshop on patient-support programmes and market-research programmes – Understanding the diversity of such programmes and the management of safety information

Reference Number: EMA/254698/2013

Presentation - Management of safety data from patient-support programmes and market-research programmes: Overview of legal requirements applicable to marketing-authorisation holders' (Gilles Touraille)

Presentation - An inspector’s perspective – Considerations for patient-support and reimbursement programmes (Anya Sookoo)

Presentation - Considerations on the assessment of safety data originating from patient-support programmes (Qun-Ying Yue)

Presentation - Spectrum of market-research programmes: Type of safety data collected

Presentation - Reporting adverse events from solicited sources to the Food and Drug Association (Gerald Pan)

Presentation - Adverse-reaction reporting and patient-support programmes / market-research programmes at Health Canada (Christopher Turner)

Presentation - Patient-support programmes and market-research programmes in pharmacies: Managing safety information (Suzete Costa)

Presentation - Workshop on patient-support programmes and market-research programmes: Reflections from the patient side (David Haerry)

Presentation - Workshop on patient-support programmes and market-research programmes: Spectrum of programmes falling under the terms of patient-support and market-research programmes and the type of safety data collected...

Presentation - International regulators’ perspectives in handling patient-support programmes and market-research programmes (Junko Sato)

Presentation - Management of safety data originating from patient-support programmes and market-research programmes - Current challenges from pharmaceutical industry and proposals to move forward