LOS DONES DE SERVICIO DEL ESPÍRITU SANTO
PARA ESTUDIO ADICIONAL: Los ejemplos de servir:
5.1 Monitoring
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5.2 If you have concerns
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5.3 Appendix 1: GSK written standards
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for activities and interactions with audience
groups not covered by this code
5.4 Appendix 2: Key written standards
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for external interactions
5.5 Appendix 3: Glossary
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5.6 Appendix 4: Abbreviations
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• POL-GSK-409: Medical
governance framework www.gsk.com/integrity Go to Connect GSK Find: Who we are Search for: Business Unit Compliance Officer External references relating to this section
Our Code of Practice for promotion and scientific engagement
5
Fu rth er in fo rma tion an d ap pe nd ic es5.1
Monitoring
5.3Appendix 1: GSK written standards for activities and
interactions with audience groups not covered by this code
Management monitoringLocal management is responsible for ensuring effective change and embedding plans are in place. A review of this procedure occurs every two years for improvement.
Independent business monitoring
Risk owners are accountable for ensuring that independent business monitoring expectations are clear for this standard. If you have concerns about how to apply this written standard bring them to the attention of your manager and/or raise them through the Medical governance framework (see POL-GSK-409). If you are aware of violations of this written standard, please report them to Compliance or through speak up channels.
To find your local speak up integrity line number or to report online, please visit: www.gsk.com/integrity
If you are out of compliance or feel you are unable to comply with the procedure please contact your Business Unit Compliance Officer.
5.2
If you have
concerns
POL-GSK-409: Medical governance framework www.gsk.com/integrity Go to Connect GSK Find: Who we are Search for: Business Unit Compliance OfficerActivity/audience group GSK written standard
Approving promotional
materials • SOP-GSKF-414: Copy approval process for materials under the GSK Code of Practice for promotion and customer interactions
Medical Information • SOP_54813: Medical Information responses to healthcare professionals and consumers
Providing grants
and donations • POL-GSK-016: Policy on grants and donations• SOP-GSK-016: Grants and donations SOP
Clinical research • POL-GSKF-408: Human subject research
Compassionate use • POL-GSK-406: Compassionate use of GSK investigational medicines
Market research • Guidance on the conduct of primary market research in GSK Pharma
• SOP_297780: US Pharma market research: criteria for designing and executing market research conducted in the US
Using digital channels
for external engagement • POL_132175: Policy for use of digital channels Engaging healthcare
professionals and other healthcare staff to provide a service
• SOP_344448: Engaging with healthcare professionals (HCPs) to provide services
• SOP-GSKF-417: Disclosure of transfers of value to HCPs and HCOs domiciled in Europe/Russia/Ukraine/Turkey
Humanitarian product
donations • POL-GSK-303: Humanitarian product donations policy• SOP-GSK-303: Humanitarian product donations standard operating procedure and emergency response
Interacting with
government officials • SOP-GSK-007: Interactions with officials from government and inter governmental agencies
Interacting with the media • POL-GSK-301: Policy on protecting and mitigating risk from internal and external communication activities • SOP-GSK-301: Procedure on protecting and mitigating
risk from internal and external communication activities • SOP-CGA-100: Global product and pipeline media
materials development and approval procedure
Interacting with patient
groups • STD_340448: Standard for interacting with patient organisations
Procurement for meetings • STD-GSK-512: Travel, meetings and expense standard for GSK employees
Our Code of Practice for promotion and scientific engagement
Section 5 Further information and appendices
5
Fu rth er in fo rma tion an d ap pe nd ic esTopic area Written standard
ABAC framework for
engaging third parties • ABAC
Safety reporting • POL-GSK-400: Management of human safety information for GSK products
• SOP-GSKF-400: Procedure for identification and tracking of patient support programmes, market research, and interactive digital media that may generate human safety information for GSK products
Engagement of third
parties • POL-GSK-007: Anti-bribery and corruption policy• Anti-bribery and corruption framework. Third party procedures and guidance
Disclosure of transfers
of value • SOP-GSKF-417: Disclosure of transfers of value to HCPs and HCOs domiciled in Europe/Russia/Ukraine/Turkey • POL-TDOR-001: Transparency data operations and
reporting (TDOR) policy
Sanctions and
export control • POL-GSK-014: Policy on sanctions and export control• SOP-GSK-014: Procedure on sanctions and export control
Maintaining privacy
and confidentiality • POL-GSK-010: Privacy of personally identifiable information
Interactions with US healthcare professional (HCPs) and a US government reimbursed product
• SOP-GSKF-420: Planning, tracking and execution of US HCP/HCI engagements
5.4
Appendix 2: Key written standards for external interactions
Abbreviated prescribing information
refers to a shortened or ‘abbreviated’ version of the full prescribing information (eg the product label/summary of product characteristics).
Donation refers to a non-monetary award, such as products, services, equipment, subsidies, employee’s time or other assets.
Grant refers to a financial award.
Stand-alone promotional meetings are meetings we initiate, intended for HCPs/ OHS, hosted independently of a congress or other third party meeting, which relate to our medicines and uses, and/or related disease or therapy areas.
Sponsored satellite symposia are
symposia which we fund and organise within the infrastructure of, and officially recognised by, a medical congress.
Healthcare organisation (HCO) means any private or public sector organisation, institution or association that is comprised of HCPs and/or that provides healthcare services, and also includes a clinic or medical practice consisting of one or more HCPs.
Healthcare professional (HCP) refers to an individual who in the course of their professional activities is authorised to prescribe, purchase, supply, administer or dispense medicines or medical devices.
Other healthcare staff (OHS) means any person who, in the course of their employment may recommend, purchase, supply or use, or influence the purchase, supply or use, of medicines. Other
healthcare staff includes but is not limited to pharmacy assistants, hospital management, primary care managers, members of formulary committees, and payer bodies such as staff in health appraisal agencies, reimbursement bodies, pricing bodies and sick funds.
Medical education comprises programmes or activities which have the intent to provide education to HCPs which is across the range of scientific information and therapeutic/prophylactic options relevant to a disease state, balanced, comprehensive and up-to-date, and which may or may not result in the award of continuing medical education (CME) points to participants. These activities are intended to improve and enhance the HCP’s skill to engage their patients and deliver care.
Medical society means a body of HCPs that specialise in a particular aspect of medicinal practice and who meet to discuss data/policies/guidelines and other matters of mutual interest to advance patient care within that discipline.
Medicine refers, for the purposes of this Code, to prescription and non-prescription medicines and vaccines
On label means that promotional material must be consistent with the approved conditions of use (eg local product label).
5.5
Appendix 3: Glossary
Our Code of Practice for promotion and scientific engagement
Section 5 Further information and appendices
5
Fu rth er in fo rma tion an d ap pe nd ic es AbbreviationABAC Anti-bribery and corruption
API Abbreviated prescribing information
CDC The Centers for Disease Control and Prevention
CET Corporate Executive Team
CMD Country Medical Director
CME Continuing Medical Education
CPD Continuing Professional Development
FMV Fair market value
GMAL Global Medical Affairs Leader
HCO Healthcare organisations
ICMJE International Committee of Medical Journals Editors
IFPMA International Federation of Pharmaceutical Manufacturers & Associations
IDM Interactive digital media
IME Independent Medical Education
LOC Local Operating Companies
MDL Medicine Development Leader
MR Market research
NICE National Institute for Clinical Excellence
NIH National Institutes of Health
PI Prescribing information
PSP Patient support programmes
RMCB Risk Management and Compliance Board
TDOR Transparency data operations and reporting
VDL Vaccine Development Leader
WHO World Health Organization
5.6
Appendix 4: Abbreviations
5.5
Appendix 3: Glossary
continued
Promotion refers to any activity undertaken by GSK or on its behalf that advertises or promotes the prescription, supply, sale, distribution or use of GSK products.
Promotional activity/material is any activity/branded material that advertises or promotes the prescription, supply, sale, distribution or use of GSK products.
Transfer of value means any transfer of value, whether of money, in kind or otherwise, made directly or indirectly to or for the benefit of a recipient.
• Direct transfers of value are those made directly by GSK to or for the benefit of a recipient.
• Indirect transfers of value are those made on behalf of GSK to or for the benefit of a recipient, or transfers of value made through an intermediate and where GSK knows or can identify the recipient.
Our Code of Practice for promotion and scientific engagement
Section 5 Further information and appendices
www.gsk.com
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