Education & Training

Education & Training

Do you want to be up to date in your sector?

Do you want to better understand the latest trends and developments, find leading colleagues in your professional field and put new knowledge into practice?. 

Thanks to our e-learning programs and conferences, we help you make the most of your professional added value. 

Is there a new law or regulation that affects your sector? 

Do you need to acquire a certification to reach the next stage in your career? 

Are you still reading about new terminology and not sure what to do? 

Our goal is to help you to do your work with more inspiration and confidence. We focus 100% on hands-on experience and interaction.

E-learning & In Company

We can assist online (e-learning) or in company in the education and training of the staff involved in your projects. The main topics we can assist are the following:

CLINICAL OPERATIONS:

  • GCPS TO SITES AND CLINICAL STAFF
  • INFORMED CONSENT FORM
  • CASE REPORT FORM
  • STANDARD TEMPLATES TO BE USED IN CLINICAL OPERATIONS
  • CSR
  • MONITORING OF THE CLINICAL TRIAL
  • IMPD
  • PNTS ACCORDING TO GCPS

REGULATORY AFFAIRS:

  • LEGAL BASIS OF THE CTD: FROM MODULE 1 TO MODULE 5 (which are the contents and guidelines to follow to be fully compliant with Regulatory requirements in the EU region)
  • MEDICAL DEVICES (Main differences between the Directive and the New Regulation)
  • COSMETICS (how to notify cosmetics and main regulations to be applied)
  • BIOCIDES
  • HERBAL PRODUCTS
  • HOMEOPATHIC PRODUCTS
  • NON-PRESCRIPTION MEDICINAL PRODUCTS and how to switch from Prescription to Non-Prescription. Documentation to be included in the Dossier.
  • BIOLOGICALS (ATMP and Biosimilars)
  • CEP 2.0
  • NITROSAMINES
  • ALIMENTARY SUPPLEMENTS. Nutritional and Health Claims

QUALITY ASSURANCE AND AUDITS

  • GMPS FOR ATMP
  • GMPS FOR STERILE PRODUCTS
  • GMPS FOR MEDICINAL PRODUCTS
  • GDPS

For any other topic, please, let us know and we will design a tailored course for you →

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