Medical affairs

All employees in Medical Affairs Department possess high scientific background. They have global experience and are familiar with the international standards and guidelines. The department provides high quality scientific contribution and can undertake tasks that cover the whole spectrum of Medical Affairs function (like medical writing, product advocacy, scientific training/presentations etc). In addition, it supports on a regular basis all the other departments of the Company (Pharmacovigilance, Clinical Operations, Regulatory affairs).

Medical support and advice during study conduct

  • Child B

Clinical and non-clinical regulatory guidance for the development of a health technology

  • Orphan Drug Designation
  • Advanced Therapy Medicinal Products
  • Medical Devices
  • Food supplements
  • Dermo-cosmetics

Medical Writing Services

  • Translation of medical documents
  • Clinical study report preparation
  • Preparation of CTD Module 2, 4 and 5 documents (Clinical and Non‐Clinical Summaries and Overviews)
  • Dissemination of study results (manuscripts, posters and presentations)
  • Medical review of PV reports
  • Clinical Evaluation and Biological Assessment Reports according to EU MDR - Regulation (EU) 2017/745

Medical and Scientific Training

  • Training of health care professionals about drugs, devices and biologics
  • Training of sale force for newly launched drugs
  • Training of nurses, physicians and pharmacists

Product Advocacy

  • Identification of Key Opinion Leaders
  • Liaison with medical co-operative groups and Hellenic Medical Societies
  • Liaison with Patient Advocacy Groups
  • Supervision and/or management of disease awareness campaigns
  • Early access programs
  • Support in management and organization of Scientific Advisory Boards