ABPI Guidance On PV And Digital Media
Guidance notes on the management of adverse events and product complaints from digital media
Guidance notes on the management of adverse events and product complaints from digital media
ABPI Pharmacovigilance Expert Network
Approval Status
Authors: The ABPI Pharmacovigilance Expert Network
Version: 2.0
Date: 8 April 2013
Acknowledgements: We thank the many stakeholders from industry, regulators and professional organisations who provided feedback in response to our consultation on the 2013 revision of this guidance document.
Guidance notes on the management of adverse events and product complaints from digital media
Table of contents
1.
Introduction
1
2.
Scope
1
3.
Legal framework and guidance
1
4.
Social media activities
4.1. Listening
4.2. Broadcasting
4.3. Engaging
3
3
3
3
5.
General points for consideration
5.1. Project management and oversight
5.2. Declaration of company involvement and responsibilities
5.3. Data privacy
4
4
4
5
6.
Training
5
7.
Collection and follow-up of AEs and PCs from company-sponsored sites
5
8.
Collection and follow-up of AEs and PCs from non-company-sponsored sites
6
Annex 1:
Abbreviations
7
Annex 2:
Definitions
8
Annex 3:
Revision history
10
Guidance notes on the management of adverse events and product complaints from digital media
1. Introduction
Digital media is used by individuals and organisations as a component of overall communication with patients and customers to create or raise awareness about diseases and treatments or for other strategic objectives. Pharmaceutical companies also use digital media for corporate awareness, clinical trial enrolment, and patient support programmes.
Consideration of company values, public expectation, legal and policy requirements are necessary for successful participation in the digital media environment. Additionally, Marketing Authorisation Holders
(MAH) have an obligation to monitor, collect and manage product safety (or quality) information which
Guidance notes on the management of adverse events and product complaints from digital media
ABPI Pharmacovigilance Expert Network
Approval Status
Authors: The ABPI Pharmacovigilance Expert Network
Version: 2.0
Date: 8 April 2013
Acknowledgements: We thank the many stakeholders from industry, regulators and professional organisations who provided feedback in response to our consultation on the 2013 revision of this guidance document.
Guidance notes on the management of adverse events and product complaints from digital media
Table of contents
1.
Introduction
1
2.
Scope
1
3.
Legal framework and guidance
1
4.
Social media activities
4.1. Listening
4.2. Broadcasting
4.3. Engaging
3
3
3
3
5.
General points for consideration
5.1. Project management and oversight
5.2. Declaration of company involvement and responsibilities
5.3. Data privacy
4
4
4
5
6.
Training
5
7.
Collection and follow-up of AEs and PCs from company-sponsored sites
5
8.
Collection and follow-up of AEs and PCs from non-company-sponsored sites
6
Annex 1:
Abbreviations
7
Annex 2:
Definitions
8
Annex 3:
Revision history
10
Guidance notes on the management of adverse events and product complaints from digital media
1. Introduction
Digital media is used by individuals and organisations as a component of overall communication with patients and customers to create or raise awareness about diseases and treatments or for other strategic objectives. Pharmaceutical companies also use digital media for corporate awareness, clinical trial enrolment, and patient support programmes.
Consideration of company values, public expectation, legal and policy requirements are necessary for successful participation in the digital media environment. Additionally, Marketing Authorisation Holders
(MAH) have an obligation to monitor, collect and manage product safety (or quality) information which