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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 medications.
In October 2014, the LEEM (pharmaceutical industry union) and the CEPS (healthcare products economic committee) signed the new Charter for information through canvassing or prospecting aimed at promoting medications, and in March 2017 the HAS (high authority of health) published a new certification reference framework. These documents aim to guarantee the quality of information provided to healthcare professionals and to strengthen the appropriate use of medications within the scope of promotional information activities.
To ensure high‑quality communication with healthcare stakeholders, guaranteeing proper use, ethical standards, and compliance with regulations (Public Health Code, DMOS rules, and Charter) during our promotional information activities on medications entrusted to us by our client laboratories, we have implemented for several years a quality approach framed in a continuous improvement process.
As part of this approach, we define a quality policy regarding information through canvassing or prospecting aimed at promoting our medications, reviewed annually, published and known to all company employees, ensuring our commitment to comply with and apply the Charter and the Reference Framework, thereby ensuring the adequacy of our promotional information activities with ethics and regulations.
As a result, our employees engaged in promotional information activities are required to comply with this regulation and, in particular, ethical rules during each visit and in all locations when meeting with healthcare professionals.
Pharmafield Group is certified for its promotional information activity by an accredited certifying body, thus guaranteeing compliance with its commitments.
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Compliance
One of Pharmafield's strengths !
Pharmafield and it’s employees apply and respect:
- Legal Rules
- All anti‑corruption laws
- Rules and procedures established by each partner Laboratory
Pharmafield monitors compliance by its employees with legal rules and internal processes as well as those of partner laboratories, especially regarding PR. We train all our employees on anti‑corruption rules and ensure compliance with all anti‑corruption laws. We have established an Anti‑Corruption Code of Ethics published and available on the intranet for all employees. The Legal and Quality Manager also serves as the Compliance Officer.
Pharmacovigilance, Complaints, and Med Info
Pharmafield's employees adhere to and implement legal regulations and procedures established by the laboratory for which they are on assignment. They receive regular training on best practices and processes related to pharmacovigilance, pharmaceutical quality complaints, and requests for scientific information.
Reports on pharmacovigilance, pharmaceutical quality complaints, and requests for scientific information are recorded in its database to address inquiries from partner laboratories and regulatory authorities.
Pharmafield digitally and physically archives pharmacovigilance declaration forms, pharmaceutical quality complaint forms, and maintains digital archives of forms for requests for scientific information.
GDPR, Data Protection and Privacy Law
Our compliance with the GDPR and the Data Protection Act ensures:
- Compliance of Pharmafield Group with the Data Protection Act,
- Security and reliability of processed data,
- Our commitment to respecting privacy and the 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 the DPO (Data Protection Officer) of PHARMAFIELD 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 legal grounds described below:
PURPOSE | LEGAL BASIS |
|---|---|
Leading and monitoring training, information, and communication activities, such as inviting to symposiums, conferences, seminars, debates, and conducting market studies, establishing scientific collaborations, or research initiatives. | Our legitimate interest in developing and maintaining our relationships with you. |
Communicating with you about new and existing products and tailoring our communication to you based on your expertise and professional interests. | Notre intérêt à communiquer sur les produits que nous vous présentons |
Managing the contracts we have with you and, in some cases, handling compensation. | The need to execute our contract with you.
|
Organizing and scheduling medical and pharmaceutical visits and meetings (both remotely and in person) and handling complaints and feedback related to the quality of visits. | Our interest in communicating about the products we present to you. |
Analysis of the adequacy of skills/mission in view of signing a service contract (consultant, speaker, investigator, expert, etc.). | Compliance with our legal obligations. |
Managing reports on adverse effects of products, handling and responding to requests for medical information. | Compliance with our legal obligations. |
Gérer les commandes, demandes et réclamations produits pour les pharmaciens uniquement | The necessity to execute our contract with you. |
Conducting statistics. | Our legitimate interest in developing our relationship with you. |
Complying with all legal obligations including transparency obligations or those related to anti‑gift laws. | Compliance with our legal obligations. |
Vos données peuvent être collectées indirectement auprès de sources externes. Ces données sont relatives à votre vie professionnelle et peuvent être transmises à des sources publiques (ex : plateforme des données publiques françaises, site internet du fichier national des établissements sanitaires et sociaux) ou privées (achat de base de données auprès de prestataires). Vos données peuvent être communiquées aux personnes habilitées de Pharmafield Groupe et de ses laboratoires partenaires (Affaires médicales, Pharmacovigilance, Marketing, Qualité, Clients, Ventes, Juridiques, Informatiques), aux prestataires et sous‑traitants mandatés par nos soins ou aux autorités compétentes.
Your data may be collected indirectly from external sources. These data relate to your professional life and may be obtained from public sources (e.g., the French public data platform, the website of the national file of health and social establishments) or private sources (databases purchase from providers). Your data may be disclosed 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 competent authorities.
Pharmafield uses the collected data to manage its relationship with healthcare professionals and to 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 duration in accordance with the regulations on this matter. Healthcare professionals have the right to access, rectify, or delete their personal data, to request its portability if applicable, to obtain the limitation of the processing of their personal data, to object to such processing, and to give instructions regarding the use of their data after their death. They also have the right to withdraw their consent at any time. However, for the purposes of pharmacovigilance and transparency, there is no right to object or delete data. If you wish to ask 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 (French national data protection authority https://www.cnil.fr/) in case of violation of your rights.
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