Confidence Beyond Compliance
Marketing Authorization Holders are legally required to have a dedicated medical information service in place for their marketed medicinal products (Article 98 of Directive 2001/83/EC indicates that “the marketing authorization holder shall establish, within his undertaking, a scientific service in charge of information about the medicinal products which he places on the market”).
The legislation also reinforces the importance of regulating the quality of the information made available to patients and healthcare professionals, as well as setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products (Article 88a of Directive 2004/27/EC amending Directive 2001/83/EC).
PharmaLex can help clients to consolidate their local presence worldwide through a dedicated network of Medical Information Experts, speaking more than 40 languages and with extensive industry expertise. We are committed to developing Medical Information departments to become the leading source of high-quality, balanced and constructive information.
Medical Information Services
- Service managed by Medical Information experts with long-term experience in different therapeutic areas
- Provision of Medical Information Officers with native language skills for all EU countries
- Provision and set up of a fully compliant Medical Information database
- Preparation and maintenance of Frequently Asked Questions (FAQ) and Standard Response Letters (SRL)
- Provision of a full FIRST line multi-lingual call center support for medical information inquiry management
- Provision of SECOND line support by an in-house medical team (Health Care Professionals and Safety Physicians)
- Compliance with local/global legislation and client procedures and requirements
- Management of product complaints, adverse events, device incidents and non-medical inquiries
- Promotional material review handling
- Review of training materials
- Scientific statements consistent with product labeling and regulatory guidance