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Quality & Regulatory
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Quality approach
The quality of medical information is a major public health issue, particularly regarding the information provided to healthcare professionals about medicines.
In October 2014, LEEM (Association of Pharmaceutical Companies) and CEPS (Economic Committee for Healthcare Products) signed the new Charter on Information by Canvassing or Prospecting for the Promotion of Medicines (the Charter), and in March 2017, HAS (French Health Authority) published a new certification framework. These documents are intended to ensure the quality of information provided to healthcare professionals and to strengthen the proper use of medicines in the context of promotional activities.
To ensure that healthcare stakeholders receive high‑quality communication; guaranteeing proper use, ethical compliance, and adherence to regulations (Public Health Code, LEA rules (Regulatory Framework for Benefits), and the Charter)‑during our promotional information activities on medicines entrusted to us by our partner laboratories, we have implemented, over several years, a quality approach grounded in continuous improvement.
As part of this approach, we define a quality policy for promotional activities, reviewed annually, communicated to all employees, and fully integrated into our corporate practices. This policy guarantees our commitment to comply with and apply the Charter and certification framework, ensuring that all our promotional information activities adhere strictly to ethical and regulatory standards.
Consequently, all employees engaged in promotional information activities are required to comply with these regulations, including ethical standards, during every visit and at every interaction with healthcare professionals.
Pharmafield Group is certified for its promotional information activities by an accredited certification body, thereby formally guaranteeing the fulfillment of its commitments.
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Compliance
One of Pharmafield's strengths!
Pharmafield and its employees rigorously apply and adhere to:
- All applicable laws and regulations
- All anti‑corruption legislation
- The rules and procedures established by each partner laboratory
Pharmafield monitors its employees' compliance with legal requirements, internal processes, and partner laboratory standards, particularly regarding public relations. All employees receive training on anti‑corruption rules, and adherence to all relevant anti‑corruption laws is strictly enforced. We have implemented an Anti‑Corruption Code of Ethics, which is distributed and made available on the intranet for all employees.
Pharmacovigilance, complaints and medical information
Pharmafield employees comply with and apply the legal requirements and procedures of the laboratory to which they are assigned. They receive regular training on best practices and processes in pharmacovigilance, pharmaceutical quality complaints, and scientific information requests.
All pharmacovigilance reports, quality complaints, and scientific information requests are recorded to ensure timely responses to partner laboratories and regulatory authorities.
Pharmafield archives pharmacovigilance and quality complaint forms both digitally and physically, and ensures that scientific information request forms are effectively archived digitally.
SPECIALIST IN THE HEALTHCARE ECOSYSTEM
Pharmafield offers a comprehensive solution for the outsourcing of your LEA (Law on the Regulation of Benefits) & Transparency activities, including:
• Opening accounts with official regulatory bodies
• Managing and monitoring events:
- Impromptu meals
- Staff meetings / public relations
- Congresses
- Booth rentals
• Declarations to official regulatory bodies
• Transparency publications
Pharmafield ensures full regulatory compliance while providing exemplary representation of the laboratory's image.
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GDPR, Data Protection Act
Our compliance with the GDPR and the Data Protection Act guarantees:
- Pharmafield Group's compliance with the Data Protection Act,
- The security and reliability of the data processed,
- Our commitment to respecting the privacy and rights of individuals whose data is processed.
For any questions regarding the processing of your personal data, to obtain additional information or to exercise your rights, please contact Pharmafield's DPO (Data Protection Officer) by sending an email to: dpo@pharmafield.fr
In accordance with current data protection legislation, your data is processed by Pharmafield Group for the purposes and on the grounds described below:
PURPOSE | LEGAL BASIS |
|---|---|
Conduct and monitor training, information and communication activities, for example to invite participants to conferences, seminars, debates, and conduct market studies, set up scientific collaborations or research activities. | Our legitimate interest in developing and maintaining our relationship with you. |
Communicate with you about new and existing products, and tailor our communication to you based on your expertise and professional interests. | Our interest in communicating about the products we present to you. |
Manage the contracts we have with you and in some cases manage remuneration. | The need to perform our contract with you. |
Organize and plan medical and pharmaceutical visits and meetings (remotely and in person) and manage complaints and comments related to the quality of visits. | Our interest in communicating about the products we present to you. |
Analysis of the suitability of skills/mission with a view to signing a service provision contract (consultant, speaker, investigator, expert, etc.). | Compliance with our legal obligations. |
Manage feedback regarding adverse product effects, manage and respond to requests for medical information. | Compliance with our legal obligations. |
Manage product orders, requests and complaints for pharmacists only. | The need to perform our contract with you. |
Create statistics. | Our legitimate interest in developing our relationship with you. |
Comply with all legal obligations, including transparency obligations or those relating to the anti‑gift law. | Compliance with our legal obligations. |
Your data may be collected indirectly from external sources. This data relates to your professional life and may be transmitted to public sources (e.g., French public data platform, website of the national file of health and social establishments) or private sources (purchase of databases from service providers). Your data may be communicated to authorized persons of Pharmafield Group and its partner laboratories (Medical Affairs, Pharmacovigilance, Marketing, Quality, Customers, Sales, Legal, IT), to service providers and subcontractors mandated by us or to the competent authorities.
Pharmafield uses the data collected to manage its relationship with healthcare professionals and meet transparency obligations. They will be kept for the time necessary to manage this relationship and, in the case of a pharmacovigilance report, for a period in accordance with the relevant regulations. You, healthcare professionals, have the right to access, rectify or delete your personal data, to request portability where applicable, to obtain the limitation of the processing of your personal data, to object to this processing, and to give instructions on the fate of your data after your death. You also have the right to withdraw your consent at any time. However, for the purpose relating to pharmacovigilance and transparency, you do not have the right to object or delete. If you wish to send us a question and/or exercise your rights, you can contact us at the following email address: dpo@pharmafield.fr . You can also submit a complaint to the CNIL ( https://www.cnil.fr/ ) in the event of a violation of your rights.
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