Publicity and Compliance

We support you in ensuring compliance of the promotional materials for your medicinal and healthcare products and of the promotional activities you sponsor or organize.

Publicity

As defined in Art 98 of Directive 2001/83 as amended, Marketing Authorisation Holders shall establish a scientific service for Medical Information.
In Belgium, this requirement is transposed in a Royal Decree that requires a Qualified Person Responsible for Information and Publicity (QP RIP) to be appointed and notified to the Health Authorities. IN2Pharma staff can act as QP RIP for your business in Belgium but also in the Netherlands and Luxembourg review and approve promotional material in compliance with applicable EU and local legislation.
IN2pharma offers support in all publicity for your medicinal and healthcare products in compliance with the applicable local legislation and regulatory requirements in Belgium, Luxembourg and the Netherlands. This includes (but is not limited to) the following tasks:

  • Act as primary contact person for publicity to the local health authorities
  • Review, suggest changes and/or approve local promotional material in compliance with local legislation on advertising
  • Obtain approval from Authorities for advertising to the general public
  • Establish or maintain local SOPs on Publicity, medical questions and Sample management to ensure these activities are compliant with local legislation and the Deontological Codes: Mdeon, Pharma.be, MedTech, CGR, … as applicable
  • Facilitate the implementation and training of concerned staff in these SOPs
  • Establish or maintain a control system for medical sample monitoring
  • Control the distribution of medical samples to healthcare professionals and report to the Belgian Authorities as required
  • Sign-off the declaration of conformity, certifying that any translations of the (scientific) leaflet of your medicinal products are conform to the respective current approved (scientific) leaflet
  • Oversee the training of medical sales representatives to ensure an adequate medical education
Interested? Get in touch!

Compliance & Transparency

Following several scandals on corruption in Big Pharma, healthcare compliance is a hot topic in most pharmaceutical and healthcare companies. According to recent local legislation, transfers of value from these companies to Healthcare Professionals (HCP) and Organizations (HCO) must be publicly disclosed on betransparent.be (B), Transparantieregister Zorg (NL) and via APL (Lux) every year.
IN2Pharma is well experienced in healthcare compliance and transparency requirements in Benelux. The support we offer includes (but is not limited to) the following tasks:

  1. Act as primary contact person for transparency to the local health authorities
  2. Provide training and advice on local healthcare compliance requirements
  3. Review and approve promotional activities and premiums & benefits: Compensation of services (speaker & consulting services by HCPs), Sponsorships and grants, Gifts and Hospitality in the context of scientific events
  4. Establish or maintain local SOPs on Promotional activities, Premiums & Benefits to HCP/Os to ensure these activities are compliant with local legislation and the Deontological Codes (Mdeon, Pharma.be, MedTech, CGR,…)
  5. Facilitate the implementation and training of concerned staff in these SOPs
  6. Review Mdeon visum applications in order to obtain the required visum in time
  7. Support in the establishment of contracts with HCPs and HCOs
  8. Upload or facilitate the preparation of the transparency file to be disclosed on national platforms
Interested? Get in touch!

Phone

+32 16 891 600

Location

Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium

Email

info@in2pharma.com

Social Media

Junior Consultant vacancy

Are you keen to discover the pharmaceutical industry and to get introduced to Quality Assurance, Pharmacovigilance, Regulatory Affairs and/or Promotion & Publicity for pharma and healthcare products? As Junior Consultant at IN2Pharma, you will be trained in several of these domains and depending on your skills and interest, we will find out together where your passion lies. Do you hold a Master degree in pharmaceutical or other sciences and are you eager to learn? Apply by sending your CV and motivation to jobs@in2Pharma.com

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Medical Affair Vacancy

We are looking to expand our team with a Medical Affairs colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people
and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.

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QA Consultant

We are looking to expand our team with a Quality Assurance colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.

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