Regulations

Regulations Regulations
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Pharmafield Groupe
  • Our profession
  • Why us?
  • Our specificities
  • Key figures
  • Recruitment
  • Testimonials
  • Contact
  • FR | EN

Regulations

Quality approach

Quality medical information is a major public health challenge, notably for information on medicines supplied to healthcare professionals.

In October 2014, the LEEM (Union of Medical Product Companies) and the CEPS (Economic Committee for Healthcare Products) signed the new Charter of information by direct contact or prospecting aimed at the promotion of medicinal products (the Charter) and, in March 2017, the HAS (French National Authority for Health) published new certification guidelines. The purpose of these documents is to ensure the quality of the information presented to healthcare professionals and to strengthen the proper use of medicinal products in the context of promotional information activities.

In order to ensure quality communication with other healthcare players in terms of good practices, compliance with ethical principles and the regulations (French Code of Public Health, rules laid down in France’s DMOS law and the Charter) during our promotional information activities for the medicinal products entrusted to us by our customer Laboratories, we have developed a quality approach over the years that is part of our continuous improvement process.

As part of this approach, we have defined a quality policy for information by direct contact or prospecting aimed at the promotion of our medicinal products that is reviewed every year, is distributed and is known by all of the company’s employees; it is a guarantee of our commitment to comply with and apply the Charter and the Guidelines, thus ensuring that our promotional information activities are in line with ethical principles and the regulations.

When our employees carry out their promotional information activity they are required to comply with these regulations – and notably the rules of ethical conduct – during each visit and in all places during meetings with healthcare professionals.

The Pharmafield Group is certified for its promotional information activity through an accredited certification organisation, thus guaranteeing the compliance of its commitments.

Compliance

One of Pharmafield’s strengths!

Pharmafield and its employees apply and follow:

  • The legal regulations,
  • All anticorruption laws,
  • The rules and procedures laid down by each partner Laboratory.

Pharmafield monitors its employees’ compliance with the legal regulations and in-house processes as well as those of our partner laboratories, notably in terms of PR. We train all of our employees in the anticorruption rules and we ensure that all anticorruption laws are followed by everyone. We have implemented a Code of anticorruption ethics that is distributed and is available to all employees on our intranet. The legal and quality manager is also the Compliance Officer.

Pharmacovigilance, complaints and Infomed

Pharmafield’s employees apply and follow all the legal regulations and procedures at the laboratories where they carry out their missions, they receive regular training in good practices and in the processes for pharmacovigilance, pharmaceutical quality complaints and requests for scientific information.

Pharmacovigilance and pharmaceutical quality complaint declarations, as well as requests for scientific information, are recorded in the database so as to able to respond to requests from our partner laboratories and the authorities.

Pharmafield keeps physical and computer archives of the pharmacovigilance and quality complaint declaration forms and a computer archive of the scientific information request forms.

GDPR, French Data Protection Act

Our compliance with the GDPR and the French Data Protection Act (Loi Informatique et Libertés) ensures:

  • The Pharmafield group’s compliance with the French Data Protection Act,
  • The safety and reliability of the data processed,
  • Our commitment to respect privacy and the rights of the people whose data are processed.
dpo@pharmafield.fr

Downloads

Certification guidelines

Charter of information by direct contact or prospecting aimed at the promotion of medicinal products

Pharmafield Certificate

Pharm French West Indies DOM Certificate

Pharm Indian Ocean DOM Certificate

Privacy policy

Please send your requests for information or your complaints to the following e-mail address: responsablequalite@pharmafield.fr

25 boulevard Vital Bouhot 92200 - Neuilly-sur Seine

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25 boulevard Vital Bouhot
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