European Medicines Agency Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting
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Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting on 4 June 2015 (PDF/151.59 KB)
Draft
First published: 27/05/2015
Last updated: 01/09/2015
EMA/167496/2015 -
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List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 4 June 2015 (PDF/97.52 KB)
First published: 01/09/2015
Last updated: 01/09/2015
EMA/167550/2015 -
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Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 4 June 2015 (PDF/104.64 KB)
First published: 01/09/2015
Last updated: 01/09/2015
EMA/167556/2015 -
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EU network strategy to 2020 (Noel Wathion and Monica Dias) (PDF/163.93 KB)
First published: 01/09/2015
Last updated: 01/09/2015 -
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Update on product shortages due to manufacturing/GMP and quality issues (Brendan Cuddy) (PDF/543.34 KB)
First published: 01/09/2015
Last updated: 01/09/2015
The Agency invites all stakeholders (e.g. healthcare professionals, patients' organisations, the general public) to submit data relevant to this procedure. This is in accordance with Article 107j(1) of Directive 2001/83/EC.
The following requirements apply for data to be considered:
- Submissions must be accompanied by the submission form below, with all fields completed. The form must be used with Adobe Reader X+ or Adobe Acrobat X+:
Stakeholder's submission form
- Data submitted should make reference to the Pharmacovigilance Risk Assessment Committee (PRAC) questions:
PRAC list of questions to be addressed by stakeholders
- The submission of all data should take place by 11 March 2013.
Submitting data
Send the completed form electronically to the stakeholders' submission inbox (public@ema.europa.eu). Specify the name of the medicine in the subject line of the e-mail.
The size of the submission file should not exceed 25 MB. If your attempt to send your data package to the dedicated e-mail address is unsuccessful, please use alternative submission means.
It is of the utmost importance that data are provided promptly, to avoid undermining the safety review. Due to the urgent nature of the procedure, you are strongly advised to submit your data in English.
Protection of personal data
Personal data submitted are subject to data-protection rules as established by Regulation (EC) 45/2001. They will be treated in accordance with the specific privacy statement for public consultations (EMA/310325/2012).
Treatment and publication of data
Data submitted will be received and recorded by the Agency.
The Agency will prepare a list of all submissions received, which will be published as an annex to the PRAC assessment report for transparency purposes and public awareness.
Please note that all data submitted in the context of this procedure may be shared and disclosed in the public domain.