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Regulatory Affairs Training Courses

As already known to all professionals in the sector of medicines, biocides, medical devices, food supplements, cosmetics and similar products, national and European regulations are under continuous progress. This has gradually led toward the definition of a new highly-specialised role: the regulatory affairs specialist.

Sometimes, corporate managers cannot keep pace with the continuous growth of regulations and requirements to be implemented. Aware of the corporate dynamics, and the need of corporate managers to be familiar with the essential notions of these regulations, Di Renzo Regulatory Affairs has instituted specific courses held by their experts.

These individual or group courses can be held on-line or at our premises. On request, they can also be held at the client’s office. They can be focused on the sector’s regulations, concerning general themes or on specific topics proposed by the company.

The topics treated in our courses include:

  • Essential regulations and national and European registration procedures regarding the following sectors:
    • Medicinal products
    • Medical devices
    • Food supplements
    • Biocides
    • Cosmetics
  • Basic pharmacovigilance notions
  • Introduction to scientific information and related obligations
  • Specific regulatory courses for API and medicinal product manufacturing sites; regulatory requirements and AIFA procedures