Pharmaceutical sector training

Training in the pharmaceutical sector

the topics of the information interventions

 

The actual training interventions, which LNAge, through the different professionalisms present within its staff, provides to other CROs and to public and private research institutions, have as their object both specialized issues and transversal disciplines, in any case always closely linked to the research and development activity that our company carries out daily.

• Among the subjects that are often the subject of our training interventions in the pharmaceutical sector we remember:
• clinical trials and related legal aspects, in particular:
  • informed consents;
  • privacy;
  • contracts;
• Labour law and analysis of internal contracts of companies in the pharmaceutical and biomedical sector;
• project management and clinical monitoring activities;
• use of neurological and neuropsychological scales;
• use of neuroimaging in clinical trials;
• training of the sales force on medical products and devices;
• training on transversal skills such as pharmaceutical marketing and communication in companies in the healthcare and pharmaceutical sectors;

 

 

Training in the pharmaceutical sector

courses for freelancers

For some years now, LNAge has been a real point of reference for professionals looking for training opportunities in the pharmaceutical sector.
The profession of the monitor, in fact, thanks to the economic crisis that has afflicted our country for almost a decade, has undergone a profound mutation: from subordinate work it has, in many cases, turned into an independent activity.
Beyond the differences of a fiscal and contributory nature, this step does not affect, however, the training obligations that the monitor must fulfill, based on the dictates of the Ministerial Decree of 15 November 2011.

 

The training obligations of the Monitor

 

More precisely, the monitor, even if it decides to carry out professional activities of an autonomous nature, to become such is required to:

• carry out at least 40 hours of theoretical training carried out over the 12 months preceding the start of the monitoring activities, on topics such as:
  • the methodology and regulations of the clinical trial;
  • GCP;
  • Good Manufacturing Practice (GMP) standards with specific reference to the investigational drug;
  • pharmacovigilance;
  • quality systems and quality assurance;
  • tasks of the monitor referred to in paragraph 5.18 of Annex 1 to the Ministerial Decree of 15 July 1997;
• carry out at least 20 days of monitoring activities every year, of which at least 50% at Experimental Centers;

After obtaining the qualification, the Monitor is still required to follow specific annual updates lasting not less than 30 hours on one or more of the following topics:

• methodology and legislation on clinical trials;
• GCP;
• GMP with specific reference to the investigational drug;
• quality systems;
• pharmacovigilance;
• clinical-scientific topics related to clinical trials;
• other topics related to the tasks to be performed.

Precisely for this reason, a growing number of monitors outside our company, which carry out professional activities of an autonomous nature, are increasingly turning to LNAge to attend training courses in the pharmaceutical sector and, more generally, to comply with the obligations (described above) provided for by current legislation.

 

Training interventions in other CROs

LNAge also successfully carries out its training interventions at other CROs that, lacking adequate know-how in certain services or specific activities, central to our profession, turn to our company for the design and delivery of professional training courses at their company headquarters.
A need of a similar nature also arises in those CROs that are devoid of professional figures, such as that of the monitor, of fundamental importance in health and pharmaceutical research: these companies, which in many cases are also sponsors of LNAge, turn to our company for the training of monitors that, then, will have to operate in their corporate structure.

 

SAF Training School

an innovative LNAge project

 

Precisely to better meet the growing demand for training in the pharmaceutical sector, LNAge is currently engaged in an innovative project: in fact, a professional training school in the field of clinical, pharmaceutical and biomedical research is about to be launched where numerous courses will be offered on different specialized topics and on many key aspects of the monitor profession.

 

With the choice to devote increasing attention and commitment to training activities and to start a real training institution, with a special website and courses specially designed and developed for professionals in the pharmaceutical and clinical sector, LNAge chooses to institutionalize and, at the same time, to make it more professional and effective, the commitment that you have already made a long time with passion and high professionalism towards recent graduates and young professionals.